Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Extraarticular Distal Radius Malunion
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Disability of the Shoulder and Hand Score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Jesse B. Jupiter, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Extraarticular distal radius malunion requiring surgery
- •Adult patient (\> 18 yo)
- •Fluent in English
Exclusion Criteria
- •Pregnant patient
- •Abnormal contralateral forearm
Outcomes
Primary Outcomes
Disability of the Shoulder and Hand Score
Time Frame: 0, 3, 6, 12 months
DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.
Secondary Outcomes
- Patient-Rated Wrist Evaluation (PWRE_(0, 3, 6, 12 months)
- Numerical Rating Scale for Satisfaction(0, 3, 6, 12 months)
- Numerical Rating Scale for Pain(0, 3, 6, 12 months)