Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

Phase 2

Completed

• Conditions: Extra-articular Distal Radius Malunions
• Interventions: Procedure: Corrective osteotomy with computer-assisted pre-operative planning; Procedure: Corrective osteotomy with conventional preoperative planning

• Registration Number: NCT01897246
• Lead Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery

Brief Summary

The investigators are comparing post-operative patient-rated functional outcome between patients who undergo corrective osteotomy for extra-articular malunited distal radius fractures with and without computer assisted pre-operative planning and virtual osteotomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2012-06-11
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted QC: 2013-07-09
• Last Update Submitted: 2013-07-09
• Study First Posted: 2013-07-11
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Adult (over 18 yrs of age)
• Extra-articular malunion of the distal radius
• Fluent in English

Exclusion Criteria

• Pregnant patients
• prisoners
• patients with impaired decision making ability
• patients with a bony deformity in the distal forearm contralateral to the one with distal radius malunion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computer-assisted pre-operative planning	Corrective osteotomy with computer-assisted pre-operative planning	Patients enrolled in this arm will undergo corrective surgery of the distal radius, with pre-operative computer-assisted planning and virtual osteotomy.
Conventional pre-operative planning	Corrective osteotomy with conventional preoperative planning	Patients in this group will undergo corrective osteotomy of the distal radius wit conventional pre-operative planning.

Primary Outcome Measures

Name	Time	Method
Grip Strength	Up to 12 months	Grip strength as compared to the normal, contralateral hand is considered the most important outcome measure for patients with distal radius fractures.

Secondary Outcome Measures

Name	Time	Method
Range of motion	Up to 12 months
DASH Questionnaire	Up to 12 months
Mayo Wrist score	Up to 12 months
Gartland and Werley score	Up to 12 months

Trial Locations

Locations (1)

Christine M. Kleinert Institute of Hand and Microsurgery; 🇺🇸 Louisville, Kentucky, United States