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

Study Overview
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Brief Summary
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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.

Official Title
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Vascularized vs. Non-vascularized Bone Grafting in the Treatment of Proximal Pole Scaphoid Non Unions: A Prospective Randomized Trial

Conditions
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Scaphoid Non-Unions

Intervention / Treatment
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* Procedure: Vascularized Bone Graft
* Procedure: Non-Vascularized Bone Graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vascularized Bone Graft<br>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<br>* Vascularized bone graft in the treatment of Scaphoid Non-Union<br>|
| Active Comparator: Non-Vascularized Bone Graft<br>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<br>* Non-Vascularized Bone Graft in the treatment of Scaphoid Non-unions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Measures | ROM Grip Strength Dexterity | Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scaphoid, Non-Union, Proximal pole, Bone Graft, Vascularized, Non-Vascularized, PREE