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| Name | Class |
|---|---|
| Synthes Asia Pacific | INDUSTRY |
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Case series of tibial plateau fractures using Norian Drillable.
This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norian Drillable Bone Void Filler | Device | Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment | Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR) | Day 0 (Day of surgery) |
| Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment | Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss) | Day 0 (Day of surgery) |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device | At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative | |
| Ease of Use Score Measured With a Surgeon Questionnaire: Drill | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. | Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: K-wire | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Function Assessed With the Lysholm Knee Scale | The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee. |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Zsolt Balogh, MD | John Hunter Hospital, New Lambton, NSW, Australia | Principal Investigator |
| Ian Harris, MD | Liverpool Hospital, Liverpool, NSW, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia | ||
| John Hunter Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients enrolled and treated with Norian Drillable Bone Void Filler.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment | Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR) | Posted | Median | Full Range | Minutes | Day 0 (Day of surgery) |
|
Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AORTIC VALVE STENOSIS | Cardiac disorders | MedDra (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDra (16.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Synthes GmbH | +41619656592 | clinicalaffairs.emea@synthes.com |
Not provided
| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D000092463 | Tibial Plateau Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D000092443 | Knee Fractures |
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|
|
| Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: Tap | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone. | Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. | Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Day 0 (Date of surgery) |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Day 0 (Date of surgery) |
| Surgeons Overall Satisfaction With Norian Drillable | The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon. | Surgery |
| 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only) |
| Radiographic Parameters: Depression at Baseline | The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Baseline |
| Radiographic Parameters: Depression at Surgery | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Surgery |
| Radiographic Parameters: Depression at 6 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 6 week |
| Radiographic Parameters: Depression at 12 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 12 weeks |
| Radiographic Parameters: Depression at 26 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 26 weeks |
| Radiographic Parameters:: Depression at 52 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 52 weeks |
| Radiographic Parameters: Depression at 78 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 78 weeks |
| Radiographic Parameters: Condylar Widening at Baseline | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Baseline |
| Radiographic Parameters: Condylar Widening at Surgery | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Surgery |
| Radiographic Parameters: Condylar Widening at 6 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 6 weeks |
| Radiographic Parameters: Condylar Widening at 12 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 12 weeks |
| Radiographic Parameters: Condylar Widening at 26 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 26 weeks |
| Radiographic Parameters: Condylar Widening at 52 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 52 weeks |
| Radiographic Parameters: Condylar Widening at 78 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 78 weeks |
| Radiographic Parameters: Angulation (Valgus/Varus) at Baseline | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Baseline |
| Radiographic Parameters: Angulation (Valgus/Varus) at Surgery | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Surgery |
| Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 6 weeks |
| Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 12 weeks |
| Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 26 weeks |
| Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 52 weeks |
| Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | 78 weeks |
| Knee Function and Stability: Extension at Baseline | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Baseline |
| Knee Function and Stability: Extension at 6 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 6 weeks |
| Knee Function and Stability: Extension at 12 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 12 weeks |
| Knee Function and Stability: Extension at 26 Week | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 26 weeks |
| Knee Function and Stability: Extension at 52 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 52 weeks |
| Knee Function and Stability: Extension at 78 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 78 weeks |
| Knee Function and Stability: Total Range of Motion at Baseline | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Baseline |
| Knee Function and Stability: Total Range of Motion at 6 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 6 weeks |
| Knee Function and Stability: Total Range of Motion at 12 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 12 weeks |
| Knee Function and Stability: Total Range of Motion at 26 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 26 weeks |
| Knee Function and Stability: Total Range of Motion at 52 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 52 weeks |
| Knee Function and Stability: Total Range of Motion at 78 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | 78 weeks |
| Knee Function and Stability: Extension Stability at Baseline | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | Baseline |
| Knee Function and Stability: Extension Stability at 6 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | 6 weeks |
| Knee Function and Stability: Extension Stability at 12 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | 12 weeks |
| Knee Function and Stability: Extension Stability at 26 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | 26 weeks |
| Knee Function and Stability: Extension Stability at 52 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | 52 weeks |
| Knee Function and Stability: Extension Stability at 78 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | 78 weeks |
| New Lambton |
| New South Wales |
| 2305 |
| Australia |
| Queen Mary Hospital | Hong Kong | China |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 | Netherlands |
| St. Elisabeth Ziekenhuis | Tilburg | 5022 | Netherlands |
| Sykehuset I Vestfold | Tønsberg | 3103 | Norway |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height (n=32) | Mean | Standard Deviation | centimeter |
|
| Weight (n=32) | Mean | Standard Deviation | kilogram |
|
| BMI (n=32) | Mean | Standard Deviation | kg/m2 |
|
| Exercise per week | Number | participants |
|
| Occupation | Number | participants |
|
| Health status | Number | participants |
|
| Smoking status | Number | participants |
|
| Injury characteristics: side of fracture | Number | participants |
|
| Mechanism of injury | Patients may had an injury in more than one category. | Number | participants |
|
| Orthopaedic Trauma Association (OTA) fracture type | OTA = orthopaedic trauma association B2 = partial articular fracture classified as pure depression B3 = partial articular fracture classified as split depression C3 = complete articular fracture classified as multifragmentary | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment | Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss) | Posted | Mean | Standard Deviation | Cubic Centimeters | Day 0 (Day of surgery) |
|
|
|
| Primary | Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device | Posted | Number | participants | At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Drill | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Secondary | Pain and Function Assessed With the Lysholm Knee Scale | The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Median | Full Range | units on a scale | 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: K-wire | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Tap | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Primary | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. | Posted | Number | Cases | Day 0 (Date of surgery) |
|
|
|
| Secondary | Radiographic Parameters: Depression at Baseline | The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Radiographic Parameters: Depression at Surgery | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Surgery |
|
|
|
| Secondary | Radiographic Parameters: Depression at 6 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 6 week |
|
|
|
| Secondary | Radiographic Parameters: Depression at 12 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Radiographic Parameters: Depression at 26 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Radiographic Parameters:: Depression at 52 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 52 weeks |
|
|
|
| Secondary | Radiographic Parameters: Depression at 78 Weeks | The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 78 weeks |
|
|
|
| Secondary | Radiographic Parameters: Condylar Widening at Baseline | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Radiographic Parameters: Condylar Widening at Surgery | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Surgery |
|
|
|
| Secondary | Radiographic Parameters: Condylar Widening at 6 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Radiographic Parameters: Condylar Widening at 12 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Radiographic Parameters: Condylar Widening at 26 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Radiographic Parameters: Condylar Widening at 52 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 52 weeks |
|
|
|
| Secondary | Radiographic Parameters: Condylar Widening at 78 Weeks | The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 78 weeks |
|
|
|
| Secondary | Radiographic Parameters: Angulation (Valgus/Varus) at Baseline | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Radiographic Parameters: Angulation (Valgus/Varus) at Surgery | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Surgery |
|
|
|
| Secondary | Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 52 weeks |
|
|
|
| Secondary | Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks | The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 78 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension at Baseline | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Knee Function and Stability: Extension at 6 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension at 12 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension at 26 Week | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension at 52 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 52 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension at 78 Weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 78 weeks |
|
|
|
| Secondary | Knee Function and Stability: Total Range of Motion at Baseline | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Knee Function and Stability: Total Range of Motion at 6 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Knee Function and Stability: Total Range of Motion at 12 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Knee Function and Stability: Total Range of Motion at 26 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Knee Function and Stability: Total Range of Motion at 52 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 52 weeks |
|
|
|
| Primary | Surgeons Overall Satisfaction With Norian Drillable | The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon. | Posted | Number | Cases | Surgery |
|
|
|
| Secondary | Knee Function and Stability: Total Range of Motion at 78 Weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 78 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension Stability at Baseline | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Knee Function and Stability: Extension Stability at 6 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 6 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension Stability at 12 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension Stability at 26 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 26 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension Stability at 52 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 52 weeks |
|
|
|
| Secondary | Knee Function and Stability: Extension Stability at 78 Weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. | Five major protocol violations were excluded in the efficacy analysis. | Posted | Number | participants | 78 weeks |
|
|
|
| 15 |
| 33 |
| 15 |
| 33 |
| CARDIAC FAILURE | Cardiac disorders | MedDra (16.0) | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDra (16.0) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDra (16.0) | Systematic Assessment |
|
| DUODENAL ULCER | Gastrointestinal disorders | MedDra (16.0) | Systematic Assessment |
|
| DEVICE EXTRUSION | General disorders | MedDra (16.0) | Systematic Assessment |
|
| INFLAMMATION | General disorders | MedDra (16.0) | Systematic Assessment |
|
| PAIN | General disorders | MedDra (16.0) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDra (16.0) | Systematic Assessment |
|
| HEPATIC CIRRHOSIS | General disorders | MedDra (16.0) | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDra (16.0) | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | MedDra (16.0) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDra (16.0) | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDra (16.0) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTION | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| MOBILITY DECREASED | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| OSTEOLYSIS | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| TENDON PAIN | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (16.0) | Systematic Assessment |
|
| LUNG NEOPLASM MALIGNANT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra (16.0) | Systematic Assessment |
|
| MULTIPLE SCLEROSIS | Nervous system disorders | MedDra (16.0) | Systematic Assessment |
|
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDra (16.0) | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDra (16.0) | Systematic Assessment |
|
| MEDICAL DEVICE PAIN | General disorders | MedDra (16.0) | Systematic Assessment |
|
| PAIN | General disorders | MedDra (16.0) | Systematic Assessment |
|
| DEVICE EXTRUSION | General disorders | MedDra (16.0) | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTION | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| WOUND DEHISCENCE | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| WOUND HAEMORRHAGE | Injury, poisoning and procedural complications | MedDra (16.0) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| FRACTURE DELAYED UNION | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDra (16.0) | Systematic Assessment |
|
| PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDra (16.0) | Systematic Assessment |
|
| MEDICAL DEVICE REMOVAL | Surgical and medical procedures | MedDra (16.0) | Systematic Assessment |
|
Not provided
| D007718 |
| Knee Injuries |
| Title | Measurements |
|---|
|
| n/a |
|
| Title | Measurements |
|---|---|
|
| Week 52, n=24 |
|
| Week 78, n=21 |
|
| Week 104, n=4 |
|
| Title | Measurements |
|---|
|
| n/a |
|
| Title | Measurements |
|---|
|
| n/a |
|
| Title | Measurements |
|---|
|
| n/a |
|
| Title | Measurements |
|---|---|
|
| Average |
|
| Fair |
|
| Somewhat difficult |
|
| Very difficult |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Average |
|
| Fair |
|
| Somewhat difficult |
|
| Very difficult |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Average |
|
| Fair |
|
| Somewhat difficult |
|
| Very difficult |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Average |
|
| Fair |
|
| Somewhat difficult |
|
| Very difficult |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Average |
|
| Fair |
|
| Somewhat difficult |
|
| Very difficult |
|
| Missing |
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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| Title | Measurements |
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
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| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| At least 60 degrees |
|
| At least 30 degrees |
|
| At least 0-30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| At least 60 degrees |
|
| At least 30 degrees |
|
| At least 0-30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| At least 60 degrees |
|
| At least 30 degrees |
|
| At least 0-30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| At least 60 degrees |
|
| At least 30 degrees |
|
| At least 0-30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| At least 60 degrees |
|
| At least 30 degrees |
|
| At least 0-30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Average |
|
| Not dissatisfied |
|
| Somewhat dissatisfied |
|
| Very dissatisfied |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| At least 60 degrees |
|
| At least 30 degrees |
|
| At least 0-30 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Instability in extension >10 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Instability in extension >10 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Instability in extension >10 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Instability in extension >10 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Instability in extension >10 degrees |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Instability in extension >10 degrees |
|
| Missing |
|