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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Hand and Upper Limb Clinic, Canada.
Recruitment status was:  Recruiting
Information provided by:
Hand and Upper Limb Clinic, Canada Identifier:
First received: August 9, 2011
Last updated: August 17, 2011
Last verified: August 2011

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 Intervention
Scaphoid Non-Unions Procedure: Vascularized Bone Graft Procedure: Non-Vascularized Bone Graft

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Hand and Upper Limb Clinic, Canada:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 40
Study Start Date: September 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: August 9, 2011
Last Updated: August 17, 2011

Keywords provided by Hand and Upper Limb Clinic, Canada:
Proximal pole
Bone Graft
PREE processed this record on July 19, 2017