Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

Study Overview
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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.

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

Conditions
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Extraarticular Distal Radius Malunion

Intervention / Treatment
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* Procedure: Computer-Assisted Surgical Planning
* Procedure: distal radius osteotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Extraarticular distal radius malunion requiring surgery Adult patient (> 18 yo) Fluent in English Exclusion Criteria: Pregnant patient Prisoner Abnormal contralateral forearm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Surgery without computer-assisted planning. | Procedure: distal radius osteotomy<br>* 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.<br>|
| Experimental: Computer-Assisted Surgical Planning<br> | Procedure: Computer-Assisted Surgical Planning<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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