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NCT04632745 Clinical Trial

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

Distal Radius Fracture Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04632745
Other study ID # JMAT20D.390
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 15, 2020
Est. completion date October 31, 2021

Study information
Verified date November 2020
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 110
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Wrist Rehabilitation
participants will undergo immobilization for the first 6 weeks of treatment

Locations
Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fracture treatment outcome 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
See also
  Status Clinical Trial Phase
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Completed NCT04554472 - Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Completed NCT03613922 - Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures N/A
Completed NCT01823692 - Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction Phase 2
Completed NCT02286661 - Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius N/A
Completed NCT01062997 - Volar Locked Plating Versus Bridging External Fixation N/A
Not yet recruiting NCT04100317 - Spanning Bridged Plate in Comminuted Distal Radius Fractures
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Terminated NCT02744352 - Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair N/A
Completed NCT01778673 - Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study N/A
Completed NCT05558306 - Radiological vs Clinical Outcome in DRF N/A
Active, not recruiting NCT03349216 - Bier's Block Versus Systemic Analgesia Phase 2
Completed NCT04357470 - Manual Dexterity in Ulnar Styloid Fracture Patients N/A
Recruiting NCT02957240 - Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures N/A
Completed NCT03240471 - Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization N/A
Terminated NCT04089709 - Well-arm Exercise in Distal Radius Fractures N/A
Completed NCT05623865 - The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures. N/A
Completed NCT03918174 - Implementation of the Dart-throwing Motion Plane in Hand Therapy After Distal Radius Fractures N/A