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

NCT ID: NCT02066857

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

Brief 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.

Conditions

Radius; Fracture, Lower or Distal End

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Generic plaster or fiberglass cast group

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

Group Type: ACTIVE_COMPARATOR

Cast made of generic plaster or fiberglass cast material

Intervention Type: DEVICE

Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.

Generic "off the shelf" removable splint group

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

Group Type: ACTIVE_COMPARATOR

Generic "off the shelf" removable splint

Intervention Type: DEVICE

Patients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture.

Interventions

Cast made of generic plaster or fiberglass cast material

Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.

Intervention Type: DEVICE

Generic "off the shelf" removable splint

Patients will be randomized to receive a generic "off the shelf" removable splint for treatment of a non-displaced distal radius fracture.

Intervention Type: DEVICE

Other Intervention Names

No brand name applicable.; No brand name applicable

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Claudius Jarrett

Assistant Professor of Orthopaedics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudius Jarrett, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Orthopaedics and Spine Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00071060

Identifier Type: -

Identifier Source: org_study_id