Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

Mass General Brigham

Status: Completed

Conditions: Extraarticular Distal Radius Malunion

Treatments: Procedure: distal radius osteotomy; Procedure: Computer-Assisted Surgical Planning

Study type: Interventional

Funder types: Other

Identifiers

NCT01193010

2010P000444

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnant patient
• Prisoner
• Abnormal contralateral forearm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

Active Comparator group

Description:

Surgery without computer-assisted planning.

Treatment:

Procedure: distal radius osteotomy

Computer-Assisted Surgical Planning

Experimental group

Treatment:

Procedure: Computer-Assisted Surgical Planning