NCT05370365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2024

Completed
Last Updated

June 3, 2025

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

May 6, 2022

Last Update Submit

May 28, 2025

Conditions

Distal Radius Fracture

Outcome Measures

Primary Outcomes (3)

  • Patient Rated Wrist Evaluation (PRWE)

    The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

    3 months

  • Patient Rated Wrist Evaluation (PRWE)

    The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

    6 months

  • Patient Rated Wrist Evaluation (PRWE)

    The PRWE is a 15-item questionnaire designed to measure pain and wrist disability in activities of daily living.

    1 year

Secondary Outcomes (10)

  • Quick Disability of Arm and Shoulder (QuickDASH)

    3 months

  • Quick Disability of Arm and Shoulder (QuickDASH)

    6 months

  • Quick Disability of Arm and Shoulder (QuickDASH)

    1 year

  • Visual Analogue Scale (VAS)

    3 months

  • Visual Analogue Scale (VAS)

    6 months

  • +5 more secondary outcomes

Study Arms (2)

4 week cast

EXPERIMENTAL

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.

Procedure: Below elbow cast

6 week cast

EXPERIMENTAL

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.

Procedure: Below elbow cast

Interventions

Below elbow castPROCEDURE

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

4 week cast6 week cast

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, 08021, Spain

Location

Related Publications (1)

  • Sala-Pujals A, Portes Chiva A, Chillon Soria J, Valverde Vilamala D, Dominguez Font E, Pardo Pol A. Immobilization Time for Conservative Treatment of Distal Radial Fractures in Elderly Patients: A Randomized Controlled Trial. J Bone Joint Surg Am. 2025 Jun 5;107(14):1628-1635. doi: 10.2106/JBJS.24.01480.

    PMID: 40472139DERIVED

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Data from the demographic data collection and the outcome parameters will be cleaned blindly from the treatment data
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective single-blinded randomised clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2022

First Posted

May 11, 2022

Study Start

April 20, 2021

Primary Completion

November 6, 2022

Study Completion

November 3, 2024

Last Updated

June 3, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)