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

Sponsor
Rothman Institute Orthopaedics (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04632745
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
11.5
Anticipated Duration (Months)
9.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Wrist Rehabilitation
 N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 15, 2020
Anticipated Primary Completion Date :
Oct 31, 2021
Anticipated Study Completion Date :
Oct 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Fracture treatment outcome [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

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rothman Orthopaedic Institute Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier:
NCT04632745
Other Study ID Numbers:
  • JMAT20D.390
First Posted:
Nov 17, 2020
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures

Study Results

No Results Posted as of Nov 17, 2020