Intramedullary Nailing Versus External Ring Fixation for Surgical Treatment of Tibial Shaft Fractures in Adults and Their One Year Outcome on Recovery: Study Protocol for a Pragmatic Randomized Controlled Trial (The IMVEX Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tibial Shaft Fracture
- Sponsor
- Aalborg University Hospital
- Enrollment
- 67
- Locations
- 3
- Primary Endpoint
- The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.
Detailed Description
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures. The primary aim of the project is to compare the one-year Knee Injury and Osteoarthritis Outcome Score - Sport (KOOS-Sport) after standard intramedullary nailing with external ring fixation for patients with tibial shaft fractures. The explorative aim is to report the effect of the two surgical procedures on the development of complications, time to bone union, pain reactions, muscle strength, activity of daily living and time to return to work.
Investigators
Rasmus Elsøe
Head of Orthopaedic trauma
Aalborg University Hospital
Eligibility Criteria
Inclusion Criteria
- •Fracture of the tibial shaft
- •OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3
- •The fracture type is deemed operable by intramedullary nail
Exclusion Criteria
- •Below 18 years of age
- •Open fracture
- •History of severe systemic diseases or cancer
- •Bilateral tibial shaft fracture
- •Multi fracture patients
- •Pregnancy
- •Patients without gait function prior to fracture
Outcomes
Primary Outcomes
The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
Time Frame: 12 month follow up
KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Secondary Outcomes
- Patient Acceptable Symptom State (PASS)(3+6+12 months)
- Radiological alignment(6 weeks, 3+6+12 months)
- Patient-reported pain reactions(6 weeks, 3+6+12 months)
- Pain sensitivity(6 weeks, 3+6+12 months)
- Health related QOL(6 weeks, 3+6+12 months)
- Health economic evaluation(12 months)
- Perceived Pain(6 weeks, 3+6+12 months)
- Gait assessment(3+6+12 months)
- Muscle strength(6+12 months)
- Time to bone union(6 weeks, 3+6+12 months)
- The Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 weeks, 3+6+12 months)
- Time to return to work(6 weeks, 3+6+12 months)
- Foot And Ankle Outcome Score (FAOS)(6 weeks, 3+6+12 months)