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Clinical Trials/NCT04632745
NCT04632745UnknownNot Applicable

A Prospective Randomized Evaluation of Splinting and Casting for Distal Radius Fractures in the Elderly

Rothman Institute Orthopaedics1 site in 1 country110 target enrollmentStarted: November 15, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
110
Locations
1
Primary Endpoint
Fracture treatment outcome

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Cast Group

Other

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

Intervention: Wrist Rehabilitation (Other)

Splint Group

Other

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

Intervention: Wrist Rehabilitation (Other)

Outcomes

Primary Outcomes

Fracture treatment outcome

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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