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The medical device has been withdrawn from the market due to technical issues.
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The purpose of this study is to evaluate the performance of Dynamic Locking Screws (DLS) used to stabilize the shaft component of distal femur fractures in comparison to standard locking screws (SLS). The hypothesis is that DLS will lead to better functional outcomes (WOMAC score) due to increased and more symmetrical callus formation and fewer non-unions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLS 5.0 (Dynamic Locking Screws) | Active Comparator | ORIF with DLS 5.0 (Dynamic Locking Screws) |
|
| SLS (Standard locking screw) | Active Comparator | ORIF with SLS (Standard locking screw) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLS 5.0 (Dynamic locking screws) | Device | Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Index (WOMAC) | To assess pain, stiffness, and physical function | 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up-and-go Test (TUG) | The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. Gardner, MD | Washington University School of Medicine | Principal Investigator |
| Sean E. Nork, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States | ||
| University of Missouri Orthopaedics |
Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits.
The multicenter international study enrolled patients with distal femur fractures which were either stabilize with a Dynamic Locking Screw or a standard locking screw. The study was stopped due to implant breakages observed after planned implant removals in non-study patients treated with the DLS 5.0mm.
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| ID | Title | Description |
|---|---|---|
| FG000 | DLS 5.0 (Dynamic Locking Screws) | ORIF with DLS 5.0 (Dynamic Locking Screws) DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0 |
| FG001 | SLS (Standard Locking Screw) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| SLS (Standard locking screw) | Device | Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw) |
|
| 12 weeks ± 7 days, 6 months ± 30 days |
| Quality of Life (EuroQol-5D) | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
| Range of Motion (ROM) | Assessment of passive ROM of the knee (flexion - extension) | 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
| Full Weight-bearing Status | Assessment of the timepoint when the patient :
| weekly measurement at home |
| WOMAC | To assess pain, stiffness, and physical function | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
| Columbia |
| Missouri |
| 65212 |
| United States |
| Washington University Orthopedics | St Louis | Missouri | 63110 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Wilhelminenspital | Vienna | Austria |
| Charité Berlin, Campus Virchow Klinikum | Berlin | 13353 | Germany |
| Universitätsklinikum des Saarlandes | Homburg | 66421 | Germany |
| BGU Tübingen | Tübingen | 72076 | Germany |
| Cantonal Hospital Chur | Chur | 7000 | Switzerland |
| Luzerner Kantonsspital | Lucerne | 6000 | Switzerland |
| Universitätsspital Zürich | Zurich | 8091 | Switzerland |
ORIF with SLS (Standard locking screw) SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw) |
| COMPLETED |
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| NOT COMPLETED |
|
|
Study was stopped
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| ID | Title | Description |
|---|---|---|
| BG000 | DLS 5.0 (Dynamic Locking Screws) | ORIF with DLS 5.0 (Dynamic Locking Screws) DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0 |
| BG001 | SLS (Standard Locking Screw) | ORIF with SLS (Standard locking screw) SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Western Ontario and McMaster Universities Index (WOMAC) | To assess pain, stiffness, and physical function | Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available. | Posted | 12 months after surgery |
|
| ||||||||||||||||||||||
| Secondary | Timed Up-and-go Test (TUG) | The TUG measures the time (in seconds) that it takes for an individual to rise from an armchair (chair seat height = 45 cm / 1.5 feet), walk 3 meters (= 10 feet) to a line drawn on the floor, turn around and return to the chair. The time is measured from a seated position (back against the backrest) with a stopwatch started on the command "ready - go" and stopped when the seated position is reached again. | Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available. | Posted | 12 weeks ± 7 days, 6 months ± 30 days |
| |||||||||||||||||||||||
| Secondary | Quality of Life (EuroQol-5D) | Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available. | Posted | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
|
| |||||||||||||||||||||||
| Secondary | Range of Motion (ROM) | Assessment of passive ROM of the knee (flexion - extension) | Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available. | Posted | 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
|
| ||||||||||||||||||||||
| Secondary | Full Weight-bearing Status | Assessment of the timepoint when the patient :
| Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available. | Posted | weekly measurement at home |
| |||||||||||||||||||||||
| Secondary | WOMAC | To assess pain, stiffness, and physical function | Five patients signed the informed consent form and were enrolled in the study before it was terminated. Three of the five patients were post-enrollment drop-outs and only two patients completed all study follow-up visits. No analysis was done. Due to the low number of patients an analysis was not indicated, therefore no results are available. | Posted | Preoperative, 6 weeks ±7 days, 12 weeks ± 7 days, 6 months ± 30 days, 12 months up to 425 days after surgery |
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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 | DLS 5.0 (Dynamic Locking Screws) | ORIF with DLS 5.0 (Dynamic Locking Screws) DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0 | 0 | 2 | 0 | 2 | ||
| EG001 | SLS (Standard Locking Screw) | ORIF with SLS (Standard locking screw) SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw) | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Manager of Clinical Investigation and Documentation | AO Foundation | 0041 44 200 24 67 | andreas.faeh@aofoundation.org |
| ID | Term |
|---|---|
| D000092524 | Femoral Fractures, Distal |
| D005264 | Femoral Fractures |
| D057068 | Periprosthetic Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| >=65 years |
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| Male |
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| Germany |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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