N/A
N=5
Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly
Radius; Fracture, Lower or Distal End
Bottom Line
View on ClinicalTrials.gov: NCT02066857 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in Wrist Range of Motion (ROM)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cast made of generic plaster or fiberglass cast material (Device); Generic "off the shelf" removable splint (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Wrist Range of Motion (ROM) |
— | — |
| PRIMARY Mean Mayo Wrist Score |
31.67; 46.67; 65; 78.33 | — |
| PRIMARY Change in Grip Strength |
— | — |
| PRIMARY Complication Rate |
— | — |
| PRIMARY Mean Pain Score |
6; 3.66; 1.67; .33 | — |
| SECONDARY Mean Disabilities of the Arm and Shoulder (DASH) Questionnaire Score |
73.03; 38.63; 23.33; 11.67 | — |
| SECONDARY Change in SF-12 QOL |
— | — |
Summary
The purpose of this prospective randomized study is to add to the body of knowledge on the treatment of minimally displaced distal radius fractures in patients over 60 years of age. The investigators believe that treating minimally displaced distal radius fractures in people over 60 with a removable splint and early range of motion will provide greater patient satisfaction, fewer complications, and earlier functional returns to pre-injury for these patients compared to those treated with a short arm cast which immobilizes the limb for at least four weeks, and has been shown to lead to longer recovery and possible residual stiffness. The investigators hope to provide sufficient evidence in directing treatment that will give the most efficacious and the most satisfactory return of prior function to patients. Since distal radius fractures in the elderly are common because of poorer bone quality, the elderly proportion of the population is increasing, and controlling health costs is of current concern, answering the question of which treatment produces the best results for all these concerns is of increasing importance now.
Eligibility Criteria
Inclusion Criteria
- Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction
- Isolated upper limb injury
- No previous wrist fracture
- Available for follow-up
- Between 60 and 100 years of age
Exclusion Criteria
- Less than 60 years of age
- Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.
Data sourced from ClinicalTrials.gov (NCT02066857). 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.