Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

Not Applicable

Completed

• Conditions: Extraarticular Distal Radius Malunion
• Interventions: Procedure: Computer-Assisted Surgical Planning; Procedure: distal radius osteotomy

• Registration Number: NCT01193010
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study is designed as a multi-center randomized controlled trial, comparing two groups of patients with symptomatic extra-articular malunited distal radius fractures. One group of patients will undergo corrective surgery of the distal radius, with preoperative computer-assisted planning and virtual osteotomy, and the other group will undergo corrective surgery, with conventional (non-computer-assisted) preoperative planning. The investigators hypothesize that computer-assisted surgical planning will result in a better functional outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-09-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2019-03
• Results First Submitted: 2019-03-18
• Results First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Results First Posted: 2019-06-21
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Extraarticular distal radius malunion requiring surgery
• Adult patient (> 18 yo)
• Fluent in English

Exclusion Criteria

• Pregnant patient
• Prisoner
• Abnormal contralateral forearm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-Assisted Surgical Planning	Computer-Assisted Surgical Planning	-
Control	distal radius osteotomy	Surgery without computer-assisted planning.

Primary Outcome Measures

Name	Time	Method
Disability of the Shoulder and Hand Score	0, 3, 6, 12 months	DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale for Pain	0, 3, 6, 12 months	Pain rated on a scale of 0-10, where 0 is no pain and 10 is severe pain
Patient-Rated Wrist Evaluation (PWRE_	0, 3, 6, 12 months	PRWE score is a measure of wrist function. It ranges 0-100, where higher scores indication more disability and worse wrist function.
Numerical Rating Scale for Satisfaction	0, 3, 6, 12 months	Satisfaction rated on a scale of 0-10, where 0 is not satisfied and 10 is completely satisfied

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States