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| Name | Class |
|---|---|
| Synthes Canada | INDUSTRY |
| AO Research Fund | OTHER |
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The purpose of this study is to determine whether the rate of fracture healing and fracture union, repaired with the LISS device, will be as good as or better than the usual fracture fixation systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LISS | Active Comparator | Treatment of distal femur fracture with less invasive stabilization system |
|
| Standard Treatment | Active Comparator | Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plates to treat fractures of the distal femur | Device | use of dynamic condylar screws or locking condylar plates in the treatment of distal femur fractures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delayed union or nonunion of the distal femur | Determined via radiographic analysis | 12 months post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical healing | assessed by weight-bearing ability and pain | 12 months |
| Function as assessed by patient | Assessed using LEM, SMFA, and SF-36 questionnaires |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ross K Leighton, MD, FRCS(C) | Capital Health, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QEII Health Sciences Centre | Halifax | Nova Scotia | B3H 3A7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36197809 | Derived | Claireaux HA, Searle HKC, Parsons NR, Griffin XL. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2022 Oct 5;10(10):CD010606. doi: 10.1002/14651858.CD010606.pub3. |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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| LISS | Device | treatment of distal femur fractures with less invasive stabilization systems |
|
| 6 months, 12 months |
| Frequency of adverse events | 12 months |
| Range of motion | Post-op, 6 weeks, 3 months, 6 months, 12 months |
| Gait analysis | 12 months |