N/A
N=40
Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion
Extraarticular Distal Radius Malunion
Bottom Line
View on ClinicalTrials.gov: NCT01193010 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Disability of the Shoulder and Hand Score — 46.2; 51.8; 27.9; 33.8 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Computer-Assisted Surgical Planning (Procedure); distal radius osteotomy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disability of the Shoulder and Hand Score |
46.2; 51.8; 27.9; 33.8; 23.8; 24.1 | — |
| SECONDARY Patient-Rated Wrist Evaluation (PWRE_ |
50.4; 58.2; 28.7; 35.3; 22.8; 22.8 | — |
| SECONDARY Numerical Rating Scale for Pain |
5.9; 6.2; 2.4; 3.4; 2.6; 3.2 | — |
| SECONDARY Numerical Rating Scale for Satisfaction |
3.0; 2.8; 8.4; 7.5; 7.7; 7.6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Extraarticular distal radius malunion requiring surgery
- Adult patient (> 18 yo)
- Fluent in English
Exclusion Criteria
- Pregnant patient
- Prisoner
- Abnormal contralateral forearm
Data sourced from ClinicalTrials.gov (NCT01193010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.