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

NCT01419808 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-08-18

No results posted yet for this study

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

Interventions

PROCEDURE

Vascularized Bone Graft

Vascularized bone graft in the treatment of Scaphoid Non-Union

PROCEDURE

Non-Vascularized Bone Graft

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

Sponsors & Collaborators

  • Hand and Upper Limb Clinic, Canada

    lead NETWORK

Principal Investigators

  • Ruby Grewal, MD, FRCSC · Hand and Upper Limb Centre, St. Joseph's Health Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01419808 on ClinicalTrials.gov