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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-20

Study Completion Date

2024-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Distal Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective single-blinded randomised clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Data from the demographic data collection and the outcome parameters will be cleaned blindly from the treatment data

Study Groups

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4 week 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.

Group Type EXPERIMENTAL

Below elbow cast

Intervention Type PROCEDURE

Patients will be stay with a below elbow cast for 4 or 6 weeks

6 week 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.

Group Type EXPERIMENTAL

Below elbow cast

Intervention Type PROCEDURE

Patients will be stay with a below elbow cast for 4 or 6 weeks

Interventions

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Below elbow cast

Patients will be stay with a below elbow cast for 4 or 6 weeks

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No