A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly
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ClinicalTrials.gov Identifier: NCT04632745 |
Recruitment Status :
Enrolling by invitation
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Distal Radius Fracture | Other: Wrist Rehabilitation | Not Applicable |
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 |

Arm | Intervention/treatment |
---|---|
Cast Group
participant with distal radius fracture will be treated with short arm fiberglass cast
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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
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Other: Wrist Rehabilitation
participants will undergo immobilization for the first 6 weeks of treatment |
- 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

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
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

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
United States, Pennsylvania | |
Rothman Orthopaedic Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Fractures, Bone Radius Fractures Wounds and Injuries Forearm Injuries Arm Injuries |