NCT00552331
Completed
Phase 4
Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
ConditionsFemoral Fractures
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Femoral Fractures
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Delayed union or nonunion of the distal femur
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient has read and agree to the consent
- •Patient is 16 years or older (bones have finished growing)
- •The injury happened in the last 14 days
Exclusion Criteria
- •The patient taking part in another study
- •The patient has an infection at the operative site
- •The patient has a health condition that affects bone healing or interferes with their ability to complete the study requirements (questionnaires, examinations), for example Paget's disease or osteomalacia
- •The patient is taking medication that affects bone healing (such as systemic steroids)
- •The patient has malignant (tumor) disease
- •The patient is unable to attend follow-up clinic visits
Outcomes
Primary Outcomes
Delayed union or nonunion of the distal femur
Time Frame: 12 months post operative
Determined via radiographic analysis
Secondary Outcomes
- Time to clinical healing(12 months)
- Function as assessed by patient(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)
Study Sites (1)
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