A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly

Not Applicable

• Conditions: Distal Radius Fracture
• Interventions: Other: Wrist Rehabilitation

• Registration Number: NCT04632745
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

Distal radial fractures are the most common fracture of the upper extremity in adults, with a higher incidence in those 65 years of age or older. In 2009, Karl et al demonstrated that there are 25.42 distal radial fractures in this age group per 10,000 person-years in the US. Despite the frequency of distal radius fractures, there is still debate over the best method of treatment. In contrast to younger patients, patients who are 65 years or older appear to have acceptable functional outcomes and treatment satisfaction regardless of the presence of malalignment on radiographic imaging.Therefore, nonsurgical management has been shown to be a viable treatment option.

The purpose of this study is to compare non-operative treatment with a removable splint versus a short arm cast for distal radial fractures in patients who are 65 years of age or older who are indicated for non-operative fracture treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study Start: 2020-11-15
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patients greater than 65 years old with isolated distal radius fracture amenable to non-operative treatment

Exclusion Criteria

• Patients younger than 65 years old
• Open fractures (Gustilo Grade 2 or 3)
• Pathologic fractures
• Multiple fractures in the upper or lower extremities
• Fracture indicated for surgical repair of the distal radius for any reason
• Lack of health insurance
• Inability to provide consent to the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cast Group	Wrist Rehabilitation	participant with distal radius fracture will be treated with short arm fiberglass cast
Splint Group	Wrist Rehabilitation	participant with distal radius fracture will be treated with short arm velcro wrist splint

Primary Outcome Measures

Name	Time	Method
Fracture treatment outcome	6 weeks	The rate of successful outcomes of participants who are treated for a distal radius fracture nonsurgically by splinting compared to participants who are treated by casting

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States