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

NCT ID: NCT04632745

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-10-31

Brief Summary

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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

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Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cast Group

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

Group Type OTHER

Wrist Rehabilitation

Intervention Type OTHER

participants will undergo immobilization for the first 6 weeks of treatment

Splint Group

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

Group Type OTHER

Wrist Rehabilitation

Intervention Type OTHER

participants will undergo immobilization for the first 6 weeks of treatment

Interventions

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Wrist Rehabilitation

participants will undergo immobilization for the first 6 weeks of treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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JMAT20D.390

Identifier Type: -

Identifier Source: org_study_id