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

NCT04632745 | Unknown

• 1 other identifier: JMAT20D.390
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (1)

• Fracture treatment outcome

  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

  6 weeks

Study Arms (2)

Cast Group

OTHER

participant with distal radius fracture will be treated with short arm fiberglass cast

Other: Wrist Rehabilitation

Splint Group

OTHER

participant with distal radius fracture will be treated with short arm velcro wrist splint

Other: Wrist Rehabilitation

Interventions

Wrist Rehabilitation OTHER

participants will undergo immobilization for the first 6 weeks of treatment

Cast Group; Splint Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 17, 2020
• Study Start: November 15, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

US (1)