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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04632745
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
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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.


Condition or disease Intervention/treatment Phase
Distal Radius Fracture Other: Wrist Rehabilitation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Evaluation of Splinting and Casting for Distal Radius Fractures in the Elderly
Estimated Study Start Date : November 15, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632745


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04632745    
Other Study ID Numbers: JMAT20D.390
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries