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

Sponsor

Hand and Upper Limb Clinic, Canada (Other)

Overall Status

Unknown status

CT.gov ID

NCT01419808

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scaphoid Non-Unions	Procedure: Vascularized Bone Graft Procedure: Non-Vascularized Bone Graft	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2007

Anticipated Primary Completion Date :

Jul 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

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

Objective Measures [Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.]
ROM Grip Strength Dexterity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.