Vascularized Versus Non-Vascularized Bone Grafts in Treating Proximal Pole Scaphoid Non Unions

Not Applicable

• Conditions: Scaphoid Non-Unions

• Registration Number: NCT01419808
• Lead Sponsor: Hand and Upper Limb Clinic, Canada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2011-08
• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-17
• Last Update Submitted: 2011-08-17
• Study First Posted: 2011-08-18
• Last Update Posted: 2011-08-18
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Rated Wrist Evaluation	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 Outcome Measures

Name	Time	Method
Objective Measures	Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.	* ROM; * Grip Strength; * Dexterity

Trial Locations

Locations (1)

Hand and Upper Limb Centre, St Joseph's Health Care; 🇨🇦 London, Ontario, Canada