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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419808
Recruitment Status : Unknown
Verified August 2011 by Hand and Upper Limb Clinic, Canada.
Recruitment status was:  Recruiting
First Posted : August 18, 2011
Last Update Posted : August 18, 2011
Information provided by:
Hand and Upper Limb Clinic, Canada

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2007
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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

Primary Outcome Measures :
  1. Patient Rated Wrist Evaluation [ Time Frame: 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 :
  1. Objective Measures [ Time Frame: Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation. ]
    • ROM
    • Grip Strength
    • Dexterity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419808

Contact: Ruby Grewal, MD, FRCSC 519-646-6286
Contact: Joy MacDermid, BScPT, MSc, PhD 519-646-6100 ext 64636

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   
Contact: Joy C MacDermid, MScPT, PhD    519-646-6100 ext 64636   
Sponsors and Collaborators
Hand and Upper Limb Clinic, Canada
Principal Investigator: Ruby Grewal, MD, FRCSC Hand and Upper Limb Centre, St. Joseph's Health Care

Additional Information:
Responsible Party: Dr. Ruby Grewal, Hand and Upper limb Centre, St Joseph's Health Care Identifier: NCT01419808     History of Changes
Other Study ID Numbers: HULCscaphoid
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: August 2011

Keywords provided by Hand and Upper Limb Clinic, Canada:
Proximal pole
Bone Graft