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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vascularized Bone Graft | Active Comparator | 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.) |
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| Non-Vascularized Bone Graft | Active Comparator | 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.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascularized Bone Graft | Procedure | Vascularized bone graft in the treatment of Scaphoid Non-Union |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Rated Wrist Evaluation | Patients will fill out the patient rated wrist Evaluation Questionnaire | Change in PRWE score at time of Surgery (day 1) compared to two years post operation. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Measures |
| Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruby Grewal, MD, FRCSC | Contact | 519-646-6286 | ruby.grewal@sjhc.london.on.ca | |
| Joy MacDermid, BScPT, MSc, PhD | Contact | 519-646-6100 | 64636 | joy.macdermid@sjhc.london.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ruby Grewal, MD, FRCSC | Hand and Upper Limb Centre, St. Joseph's Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hand and Upper Limb Centre, St Joseph's Health Care | Recruiting | London | Ontario | N6A4L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36861269 | Derived | Fan S, Suh N, MacDermid JC, Ross D, Grewal R. Vascularized versus non-vascularized bone grafting for scaphoid nonunion without avascular necrosis: a randomized clinical trial. J Hand Surg Eur Vol. 2023 Jul;48(7):648-653. doi: 10.1177/17531934231158992. Epub 2023 Mar 1. |
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| ID | Term |
|---|---|
| D009389 | Neovascularization, Pathologic |
| ID | Term |
|---|---|
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Non-Vascularized Bone Graft | Procedure | Non-Vascularized Bone Graft in the treatment of Scaphoid Non-unions |
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