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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05370365

Enrollment

135

Registered

2022-05-11

Start date

2021-04-20

Completion date

2024-11-03

Last updated

2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

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.

Interventions

PROCEDUREBelow elbow cast

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

Prospective single-blinded randomised clinical trial

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Patient Rated Wrist Evaluation (PRWE)	3 months	The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

Secondary

Measure	Time frame	Description
Quick Disability of Arm and Shoulder (QuickDASH)	3 months	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)	3 months	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)	3 months	Flexion, Extension, radial and ulnar deviation
Complications	1 year	Stiffness, delayed and non-union and complex regional pain syndrome (CRPS).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026