Cast vs. Splints for Minimally Displaced Distal Radius Fractures in the Elderly

Emory University

Status: Completed

Conditions: Radius; Fracture, Lower or Distal End

Treatments: Device: Generic "off the shelf" removable splint; Device: Cast made of generic plaster or fiberglass cast material

Study type: Interventional

Funder types: Other

Identifiers

NCT02066857

IRB00071060

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Colles' Fracture - Distal radius fracture with dorsal angulation, apex volar (satisfies non-operative radiographic criteria before or after reduction
2. Isolated upper limb injury
3. No previous wrist fracture
4. Available for follow-up
5. Between 60 and 100 years of age

Exclusion criteria

1. Less than 60 years of age
2. Fractures that do not meet non-operative criteria or are deemed unstable by surgeon, subsequently requiring surgery after first clinic visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

5 participants in 2 patient groups

Generic plaster or fiberglass cast group

Active Comparator group

Description:

Patients will be randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.

Treatment:

Device: Cast made of generic plaster or fiberglass cast material

Generic "off the shelf" removable splint group

Active Comparator group

Description:

Subjects will be randomized and receive a generic "off the shelf" removable splint for treatment of non-displaced distal radius fracture for 6 weeks.

Treatment:

Device: Generic "off the shelf" removable splint