CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Computer-Assisted Surgical Planning +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01193010
NCT01193010N/ACompleted

Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial

Massachusetts General Hospital·interventional·Posted Sep 1, 2010·Updated Jun 21, 2019

In Brief

A clinical study evaluating Computer-Assisted Surgical Planning and distal radius osteotomy for Extraarticular Distal Radius Malunion. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAO foundation

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2010
Enrollment StartMay 1, 2010
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 15.8 years ago

Interventions

Computer-Assisted Surgical Planningprocedure

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.

distal radius osteotomyprocedure

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.