Four or Six Weeks of Immobilization in the Conservative Treatment of Distal Radius Fractures in Elderly Population?

Not Applicable

• Conditions: Distal Radius Fracture
• Interventions: Procedure: Below elbow cast

• Registration Number: NCT05370365
• Lead Sponsor: Parc de Salut Mar

Brief Summary

The purpose of this study is to compare if there are differences in wrist function and pain after a distal radius fracture treated conservatively with immobilization for 4 or 6 weeks in elderly patients after six months of follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Last Update Submitted: 2022-05-06
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11
• Primary Completion: 2022-11-06
• Study Completion: 2023-11-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Patients older than 65 years with a low energy distal radius fracture
• Intra or extraarticular distal radius fracture (A2, A3, C1, C2)
• Acceptable primary reduction (dorsal inclination <10º, radial shortening <3mm, articular gap <2mm)

Exclusion criteria:

• History of ipsilateral fracture
• Bilateral fracture
• Open fracture
• Other concomitant fracture (except ulnar styloid fracture)
• Fracture AO B
• Previous surgeries in this area
• Dementia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 week cast	Below elbow cast	Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 6 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months.
4 week cast	Below elbow cast	Patients over 65 years old with a distal radius fracture will be treated conservatively with a cast for 4 weeks. Once the immobilization will be removed, the standard rehabilitation protocol of our center used in these fractures will be carried out. The usual clinical and radiological follow-up will be performed at 3, 6 and 12 months.

Primary Outcome Measures

Name	Time	Method
Patient Rated Wrist Evaluation (PRWE)	1 year	The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

Secondary Outcome Measures

Name	Time	Method
Quick Disability of Arm and Shoulder (QuickDASH)	1 year	It is a questionnaire that looks at the ability of a patient to perform certain upper extremity activities. This questionnaire is a self-report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.
Visual Analogue Scale (VAS)	1 year	is a measuring instrument that tries to measure the amount of pain a patient feels, which is supposed to be a value that oscillates in a continuous between no pain and an extreme amount of pain.
Range Of Movement (ROM)	1 year	Flexion, Extension, radial and ulnar deviation
Complications	1 year	Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain