NCT01419808

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 18, 2011

Status Verified

August 1, 2011

Enrollment Period

4.8 years

First QC Date

August 9, 2011

Last Update Submit

August 17, 2011

Conditions

Scaphoid Non-Unions

Keywords

ScaphoidNon-UnionProximal poleBone GraftVascularizedNon-VascularizedPREE

Outcome Measures

Primary Outcomes (1)

  • Patient Rated Wrist Evaluation

    Patients will fill out the patient rated wrist Evaluation Questionnaire

    Change in PRWE score at time of Surgery (day 1) compared to two years post operation.

Secondary Outcomes (1)

  • Objective Measures

    Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.

Study Arms (2)

Vascularized Bone Graft

ACTIVE COMPARATOR

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

Non-Vascularized Bone Graft

ACTIVE COMPARATOR

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

Interventions

Vascularized Bone GraftPROCEDURE

Vascularized bone graft in the treatment of Scaphoid Non-Union

Vascularized Bone Graft
Non-Vascularized Bone GraftPROCEDURE

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

Non-Vascularized Bone Graft

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • radiologic evidence of significant scaphoid non-union advanced collapse (SNAC) wrist arthritis
  • fragmentation of the proximal pole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

London, Ontario, N6A4L6, Canada

RECRUITING

Related Publications (1)

  • Fan S, Suh N, MacDermid JC, Ross D, Grewal R. Vascularized versus non-vascularized bone grafting for scaphoid nonunion without avascular necrosis: a randomized clinical trial. J Hand Surg Eur Vol. 2023 Jul;48(7):648-653. doi: 10.1177/17531934231158992. Epub 2023 Mar 1.

    PMID: 36861269DERIVED

MeSH Terms

Conditions

Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

MetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ruby Grewal, MD, FRCSC

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruby Grewal, MD, FRCSC

CONTACT

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

Joy MacDermid, BScPT, MSc, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

August 9, 2011

First Posted

August 18, 2011

Study Start

September 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 18, 2011

Record last verified: 2011-08

Locations

CA(1)