Recruiting

Vascularized & Non-Vascularized

Sponsor:

Hand and Upper Limb Clinic, Canada

Code:

NCT01419808

Conditions

Scaphoid Non-Unions

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vascularized Bone Graft

Non-Vascularized Bone Graft

Study Details

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.

Conditions

Scaphoid Non-Unions

Study ID

NCT01419808

Start date

Sep, 2007

Status verified date

Aug, 2011

Completion date

Jul, 2012

Anticipated

Primary completion date

Jul, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.)

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.)

Interventions

Vascularized Bone Graft

Vascularized bone graft in the treatment of Scaphoid Non-Union

Non-Vascularized Bone Graft

Non-Vascularized Bone Graft in the treatment of Scaphoid Non-unions

Primary outcome measure

  • Patient Rated Wrist Evaluation [ Time Frame: Change in PRWE score at time of Surgery (day 1) compared to two years post operation. ]

Central Contacts and Locations

Central contacts

Ruby Grewal, MD, FRCSC

519-646-6286ruby.grewal@sjhc.london.on.ca

Joy MacDermid, BScPT, MSc, PhD

519-646-6100joy.macdermid@sjhc.london.on.ca

Locations

Hand and Upper Limb Centre, St Joseph's Health Care

Recruiting

London, Ontario, Canada, N6A4L6

Contacts

James H Roth, MD, FRCSC, FACS

519-646-6050james.roth@sjhc.london.on.ca

Joy C MacDermid, MScPT, PhD

519-646-6100joy.macdermid@sjhc.london.on.ca

More Information

Sponsor

Hand and Upper Limb Clinic, Canada

Last update posted

Aug 18, 2011

Last verified

Aug, 2011

Keywords

  • Scaphoid
  • Non-Union
  • Proximal pole
  • Bone Graft
  • Vascularized
  • Non-Vascularized
  • PREE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hand and Upper Limb Clinic, Canada on 2011-08-18.