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

November 11, 2020 updated by: Rothman Institute Orthopaedics

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cast Group
participant with distal radius fracture will be treated with short arm fiberglass cast
Other: Wrist Rehabilitation
participants will undergo immobilization for the first 6 weeks of treatment
Other: Splint Group
participant with distal radius fracture will be treated with short arm velcro wrist splint
Other: Wrist Rehabilitation
participants will undergo immobilization for the first 6 weeks of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 15, 2020

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JMAT20D.390

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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