Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Extraarticular Distal Radius Malunion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Surgery without computer-assisted planning.

Group Type ACTIVE_COMPARATOR

distal radius osteotomy

Intervention Type PROCEDURE

In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy.

Computer-Assisted Surgical Planning

Group Type EXPERIMENTAL

Computer-Assisted Surgical Planning

Intervention Type PROCEDURE

Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.

Interventions

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Computer-Assisted Surgical Planning

Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.

Intervention Type PROCEDURE

distal radius osteotomy

In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy.

Intervention Type PROCEDURE