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Due to slow enrollment and not being able to reach the primary endpoint
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This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (>30 cases/year) and low volume surgeons (<10 cases/year).
The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Signature Custom Guides | Active Comparator | Oxford Partial Knee implanted using Signature Custom Guides |
|
| Conventional Instrumentation | Active Comparator | Oxford Partial Knee implanted using Conventional Instrumentation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Signature Custom Guides | Device | Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Knees Achieving Optimal Alignment | Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Instruments Used During Surgery | Number of Instrument cases used to complete index surgery. | Operative |
| Knee Society Functional Score | Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Russell Schenck, Ph.D. | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic and Sports Medicine Center | Elkhart | Indiana | 46514 | United States | ||
| The Orthopaedic Center |
Bi-lateral treatment was not recorded. Each treated knee is counted as 1 participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Signature Custom Guides | Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI). |
| FG001 | Conventional Instrumentation | Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients that completed the index surgery. Bilateral treatment was not recorded, all patients are counted as 1 treated knee.
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| ID | Title | Description |
|---|---|---|
| BG000 | Signature Custom Guides | Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 5 patients age not reported |
| 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 | Percentage of Knees Achieving Optimal Alignment | Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles. | Data from all patients as treated | Posted | Number | percentage of total | 12 weeks |
|
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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 | Signature Custom Guides | Oxford Partial Knee implanted using Signature Custom Guides Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PERFORATED DIVERTICULITIS, HINCHEY IV | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 2 MM BLOOD BLISTER ON INCISION ON OPERATIVE KNEE | Injury, poisoning and procedural complications | 2 MM BLOOD BLISTER ON INCISION ON OPERATIVE KNEE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Meijer, Clinical Operations Manager | Zimmer Biomet | +31786292935 | linda.meijer@zimmerbiomet.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| D010020 | Osteonecrosis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
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|
| Conventional Instrumentation | Procedure | Traditional partial knee arthroplasty without the use of Signature technology. |
|
| 1 Year |
| Leg Alignment Femoral Varus/Valgus | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative |
| Blood Loss | Blood Loss during surgery | Right after surgery (up to 2 hours after surgery) |
| Knee Society Objective Score | Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | 1 Year |
| Oxford Knee Score | Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome | 1 Year |
| EQ5D Score | EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome. | 1 Year |
| Leg Alignment Femoral Flexion/Extension | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative |
| Leg Alignment Tibial Varus/Valgus | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative |
| Leg Alignment Tibial Flexion/Extension | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle | Directly Postoperative |
| Rockville |
| Maryland |
| 20850 |
| United States |
| University of Missouri-Columbia Hospital and Clinics | Columbia | Missouri | 65212 | United States |
| Duke University Medical Center | Durham | North Carolina | 27703 | United States |
| Joint Implant Surgeons | Columbus | Ohio | 43054 | United States |
| Texas Institute for Hip & Knee Surgery | Austin | Texas | 78751 | United States |
| Advanced Orthopedics | Richmond | Virginia | 23294 | United States |
| BG001 | Conventional Instrumentation | Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 5 patient conventional age missing | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | 5 patients gender not reported | Count of Participants | Participants |
|
| Region of Enrollment | 5 subjects no region data available | Number | participants |
|
| Conventional Instrumentation |
Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology. |
|
|
| Secondary | Instruments Used During Surgery | Number of Instrument cases used to complete index surgery. | All patients as treated | Posted | Mean | Standard Deviation | Instrument cases | Operative |
|
|
|
| Secondary | Knee Society Functional Score | Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score score completed | Posted | Mean | Standard Deviation | units on a scale | 1 Year |
|
|
|
| Secondary | Leg Alignment Femoral Varus/Valgus | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle | All patients as treated with post-operative CT collected | Posted | Mean | Standard Deviation | Degrees | Directly Postoperative |
|
|
|
| Secondary | Blood Loss | Blood Loss during surgery | All patients as treated for which blood loss is recorded | Posted | Mean | Standard Deviation | ml | Right after surgery (up to 2 hours after surgery) |
|
|
|
| Secondary | Knee Society Objective Score | Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions | All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score completed | Posted | Mean | Standard Deviation | units on a scale from 0 to 100 | 1 Year |
|
|
|
| Secondary | Oxford Knee Score | Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome | All patients, as treated, reaching the 1 year follow up datapoint with Oxford Knee Score completed | Posted | Mean | Standard Deviation | units on a scale | 1 Year |
|
|
|
| Secondary | EQ5D Score | EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome. | All patients, as treated, reaching the 1 year follow up datapoint with EQ5D score completed | Posted | Mean | Standard Deviation | units on a scale from 0 to 1 | 1 Year |
|
|
|
| Secondary | Leg Alignment Femoral Flexion/Extension | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle | All patients as treated with post-operative CT collected | Posted | Mean | Standard Deviation | Degrees | Directly Postoperative |
|
|
|
| Secondary | Leg Alignment Tibial Varus/Valgus | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle | All patients as treated with post-operative CT collected | Posted | Mean | Standard Deviation | Degrees | Directly Postoperative |
|
|
|
| Secondary | Leg Alignment Tibial Flexion/Extension | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle | All patients as treated with post-operative CT collected | Posted | Mean | Standard Deviation | Degrees | Directly Postoperative |
|
|
|
| 0 |
| 133 |
| 3 |
| 133 |
| 12 |
| 133 |
| EG001 | Conventional Instrumentation | Oxford Partial Knee implanted using Conventional Instrumentation Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology. | 0 | 133 | 6 | 133 | 18 | 133 |
| DEHISCENCE OF PROXIMAL MEDIAL CAPSULAR SUTURE | Musculoskeletal and connective tissue disorders |
|
| LAPARAOSCIPIC GASTRIC BYPASS | Gastrointestinal disorders |
|
| ARTHROSCOPIC PROCEDURE | Musculoskeletal and connective tissue disorders | PAIN AND SWELLING DUE TO LOOSE BODY RESULTING IN OUTPATIENT ARTHROSCOPIC PROCEDURE. SYNOVITIS, SMALL LATERAL MENISCAL TEAR AND PIECE OF CEMENT WERE IDENTIFIED AND REMOVED. PATIENT WENT HOME THE SAME DAY |
|
| SHOULDER PAIN | Musculoskeletal and connective tissue disorders | PAIN LEFT SHOULDER RESULTING IN SHOULDER SURGERY ON 6 OCT 2014 (IMPINGEMENT SYNDROME AND ACROMIOCLAVICULAR ARTHRITIS) |
|
| Patient Fall | General disorders | PATIENT FELL GETTING OUT OF BED DUE TO LEG NUMBNESS FROM BL SOCIAL ADMISSION TO HOSPITAL BECAUSE FALL AND NUMBNESS. SLIPPED OUT OF BED. |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | PERSISTANT PAIN PROBLEM RIGHT KNEE |
|
| Knee Gonarthrosis | Musculoskeletal and connective tissue disorders | TOTAL KNEE PROSTHESIS Contralateral ON 27 FEB 2015 DUE TO MEDIAL GONARTHROSIS LEFT |
|
| Unkown event | General disorders | Unknown description |
|
|
| Constipation | Gastrointestinal disorders |
|
| DEGENERATIVE DISC DISEASE LUMBAR SPINE | Musculoskeletal and connective tissue disorders |
|
| DELAYED WOUND HEALING | Injury, poisoning and procedural complications | DELAYED WOUND HEALING |
|
| Disease Progression | Musculoskeletal and connective tissue disorders | LATERAL COMPARTMENT DISEASE PROGRESSION |
|
| Fall | General disorders | PATIENT FALLS ON HIS KNEE |
|
| FEELING OF RIGHT KNEE GIVING WAY | Musculoskeletal and connective tissue disorders |
|
| Knee pain | Musculoskeletal and connective tissue disorders |
|
| Knee popping/clicking | Musculoskeletal and connective tissue disorders |
|
| Knee Swelling | Musculoskeletal and connective tissue disorders | Postoperative swelling |
|
| PATELLA TENDONITIS | Musculoskeletal and connective tissue disorders |
|
| POST-OP NAUSEA | Injury, poisoning and procedural complications |
|
| Rib Fracture | Injury, poisoning and procedural complications |
|
| Skin Irritation | Skin and subcutaneous tissue disorders |
|
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| D009336 |
| Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |