NCT00552331CompletedPhase 4
Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Techniques in Distal Femoral Fractures
Nova Scotia Health Authority1 site in 1 country150 target enrollmentStarted: March 1, 2003Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Delayed union or nonunion of the distal femur
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
LISS
Active Comparator
Treatment of distal femur fracture with less invasive stabilization system
Intervention: LISS (Device)
Standard Treatment
Active Comparator
Treatment of distal femoral fractures using locking condylar plates or dynamic condylar screws
Intervention: Plates to treat fractures of the distal femur (Device)
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)
Investigators
Study Sites (1)
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