Vascularized vs. Non-vascularized Bone Grafting in the Treatment of Proximal Pole Scaphoid Non Unions: A Prospective Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Scaphoid Non-Unions
- Sponsor
- Hand and Upper Limb Clinic, Canada
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Patient Rated Wrist Evaluation
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to investigate whether treatment of scaphoid non-unions with a vascularized bone grafts improves patient reported pain and disability compared to treatment with a non-vascularized bone graft. Secondary objectives are to examine if there is any difference in the overall rate and time to union, range of motion, grip strength, or complication rates between the two groups.
In addition, this is the first prospective randomized study to directly compare the two techniques. This is also the first study to use standardized methods of assessing union (based on computerized tomography), standardized methods of collecting objective patient data, and utilizing validated patient questionnaires to assess pain and disability.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The primary inclusion criterion is any scaphoid waist or proximal pole non-union in a patient receiving a recommendation for operative treatment. Non-union is defined as \<10% bony union across the fracture site on sagittal computerized tomography (CT) after at least 16 weeks of appropriate non-operative treatment or morphologic features on plain x-ray and CT (resorption and sclerosis at the fracture site, significant cyst formation) confirming non-union.
Exclusion Criteria
- •radiologic evidence of significant scaphoid non-union advanced collapse (SNAC) wrist arthritis
- •fragmentation of the proximal pole
Outcomes
Primary Outcomes
Patient Rated Wrist Evaluation
Time Frame: Change in PRWE score at time of Surgery (day 1) compared to two years post operation.
Patients will fill out the patient rated wrist Evaluation Questionnaire
Secondary Outcomes
- Objective Measures(Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.)