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

Vascularized vs. Non-vascularized Bone Grafting in the Treatment of Proximal Pole Scaphoid Non Unions: A Prospective Randomized Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419808

Enrollment

Registered

2011-08-18

Start date

2007-09-30

Completion date

2012-07-31

Last updated

2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scaphoid Non-Unions

Keywords

Scaphoid, Non-Union, Proximal pole, Bone Graft, Vascularized, Non-Vascularized, PREE

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.

Interventions

PROCEDUREVascularized Bone Graft

Vascularized bone graft in the treatment of Scaphoid Non-Union

PROCEDURENon-Vascularized Bone Graft

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient Rated Wrist Evaluation	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

Measure	Time frame	Description
Objective Measures	Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.	* ROM * Grip Strength * Dexterity

Countries

Canada

Contacts

Primary ContactRuby Grewal, MD, FRCSC

ruby.grewal@sjhc.london.on.ca519-646-6286

Backup ContactJoy MacDermid, BScPT, MSc, PhD

joy.macdermid@sjhc.london.on.ca519-646-6100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026