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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Hand and Upper Limb Clinic, Canada.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hand and Upper Limb Clinic, Canada
ClinicalTrials.gov Identifier:
NCT01419808
First received: August 9, 2011
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

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
Endpoint Classification: Efficacy Study
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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    • 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419808

Contacts
Contact: Ruby Grewal, MD, FRCSC 519-646-6286 ruby.grewal@sjhc.london.on.ca
Contact: Joy MacDermid, BScPT, MSc, PhD 519-646-6100 ext 64636 joy.macdermid@sjhc.london.on.ca

Locations
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    james.roth@sjhc.london.on.ca   
Contact: Joy C MacDermid, MScPT, PhD    519-646-6100 ext 64636    joy.macdermid@sjhc.london.on.ca   
Sponsors and Collaborators
Hand and Upper Limb Clinic, Canada
Investigators
Principal Investigator: Ruby Grewal, MD, FRCSC Hand and Upper Limb Centre, St. Joseph's Health Care
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Ruby Grewal, Hand and Upper limb Centre, St Joseph's Health Care
ClinicalTrials.gov Identifier: NCT01419808     History of Changes
Other Study ID Numbers: HULCscaphoid
Study First Received: August 9, 2011
Last Updated: August 17, 2011
Health Authority: Canada: Health Sciences Research Ethics Board, The University of Western Ontario

Keywords provided by Hand and Upper Limb Clinic, Canada:
Scaphoid
Non-Union
Proximal pole
Bone Graft
Vascularized
Non-Vascularized
PREE

ClinicalTrials.gov processed this record on April 17, 2014