Vascularized Versus Non-Vascularized Bone Grafts in Treating Proximal Pole Scaphoid Non Unions
This study is currently recruiting participants.
Verified August 2011 by Hand and Upper Limb Clinic, Canada
Sponsor:
Hand and Upper Limb Clinic, Canada
Information provided by:
Hand and Upper Limb Clinic, Canada
ClinicalTrials.gov Identifier:
NCT01419808
First received: August 9, 2011
Last updated: August 17, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Scaphoid Non-Unions |
Procedure: Vascularized Bone Graft Procedure: Non-Vascularized Bone Graft |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vascularized vs. Non-vascularized Bone Grafting in the Treatment of Proximal Pole Scaphoid Non Unions: A Prospective Randomized Trial |
Resource links provided by NLM:
Further study details as provided by Hand and Upper Limb Clinic, Canada:
Primary Outcome Measures:
- Patient Rated Wrist Evaluation [ Time Frame: Change in PRWE score at time of Surgery (day 1) compared to two years post operation. ] [ Designated as safety issue: No ]Patients will fill out the patient rated wrist Evaluation Questionnaire
Secondary Outcome Measures:
- Objective Measures [ Time Frame: Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation. ] [ Designated as safety issue: No ]
- ROM
- Grip Strength
- Dexterity
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Vascularized Bone Graft
Patients randomized to a vascularized bone graft will undergo a 1, 2-ICRSA vascularized bone graft based upon the 1,2 supra-retinacular vessels as described by Zaidemberg . (9. Zaidemberg C, Siebert JW, Angrigiani C. A new vascularized bone graft for scaphoid nonunion. J Hand Surg. 1991; 16A: 474-478.)
|
Procedure: Vascularized Bone Graft
Vascularized bone graft in the treatment of Scaphoid Non-Union
|
|
Active Comparator: Non-Vascularized Bone Graft
Patients randomized to the non-vascularized group will undergo trapezoidal bone grafting from the iliac crest as described by Fernandez . (10. Fernandez DL. A technique for anterior wedge-shaped grafts for scaphoid nonunions with carpal instability. J Hand Surg [Am]. 1984 Sep;9(5):733-7.)
|
Procedure: Non-Vascularized Bone Graft
Non-Vascularized Bone Graft in the treatment of Scaphoid Non-unions
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419808
Contacts
| Contact: Ruby Grewal, MD, FRCSC | 519-646-6286 | ruby.grewal@sjhc.london.on.ca |
| Contact: Joy MacDermid, BScPT, MSc, PhD | 519-646-6100 ext 64636 | joy.macdermid@sjhc.london.on.ca |
Locations
| Canada, Ontario | |
| Hand and Upper Limb Centre, St Joseph's Health Care | Recruiting |
| London, Ontario, Canada, N6A4L6 | |
| Contact: James H Roth, MD, FRCSC, FACS 519-646-6050 james.roth@sjhc.london.on.ca | |
| Contact: Joy C MacDermid, MScPT, PhD 519-646-6100 ext 64636 joy.macdermid@sjhc.london.on.ca | |
Sponsors and Collaborators
Hand and Upper Limb Clinic, Canada
Investigators
| Principal Investigator: | Ruby Grewal, MD, FRCSC | Hand and Upper Limb Centre, St. Joseph's Health Care |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Ruby Grewal, Hand and Upper limb Centre, St Joseph's Health Care |
| ClinicalTrials.gov Identifier: | NCT01419808 History of Changes |
| Other Study ID Numbers: | HULCscaphoid |
| Study First Received: | August 9, 2011 |
| Last Updated: | August 17, 2011 |
| Health Authority: | Canada: Health Sciences Research Ethics Board, The University of Western Ontario |
Keywords provided by Hand and Upper Limb Clinic, Canada:
|
Scaphoid Non-Union Proximal pole Bone Graft |
Vascularized Non-Vascularized PREE |
ClinicalTrials.gov processed this record on June 17, 2013