Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Distal Radius Fracture; Colles' Fracture
• Interventions: Other: Functional cast; Other: Flexion-ulnar cast

• Registration Number: NCT02894983
• Lead Sponsor: Tampere University Hospital

Brief Summary

There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Primary Completion: 2018-04
• Status Verified: 2018-05
• Study Completion: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
• Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Exclusion Criteria

• Operative treatment
• Refuse to participate the study
• Open fracture more than Gustilo 1 gradus
• Age under 65 years
• Chauffeure's or Barton´s fracture
• Smith´s fracture (volar angulation of the fracture)
• Does not understand written and spoken guidance in local languages
• Pathological fracture or previous fracture in the same wrist, forearm or elbow

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Functional cast	Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.
Arm 1	Flexion-ulnar cast	Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Primary Outcome Measures

Name	Time	Method
Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study	2 years	The PRWE comprises 15 questions to measure wrist pain and disability in daily activities. In PRWE patients rate wrist pain and disability from 0 to 10 and it consists three subscales: Pain, Function and Cosmetics.

Secondary Outcome Measures

Name	Time	Method
Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.	2 years	The QuickDASH is self-reported questionnaire and shortened version of DASH outcome measure to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb in 11 dimensions in 1-5 scale.
Pain measured in Visual Analogue Scale (VAS).	Baseline, 3 months, 1 year, 2 years	The VAS is derived by health care professional question of pain in scale 0 to 10 in which 0 implies no pain and 10 the worst possible pain.
Grip strength is measured with a dynamometer	3 months	Grip strength is measured with a dynamometer in kg as the mean of three measurements. It will be numbered in percentage of the uninjured side.
The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.	2 years	The PCS is designed to measure person's willingness to catastrophize the pain while they are experiencing it. In the questionnaire patients answer questions about how they feel and think when they are in pain and it can be taken while they are not experiencing pain.
Quality of life measured with the 15-D.	2 years	The 15D is a validated, generic, self-administered instrument for assessing the health related quality of life among adults. It combines the advantages of a preference-based and single index measure on a 0-1 scale.
Range of motion (ROM) is measured with a goniometer	3 months	The ROM of the wrist is measured on both hands with a handheld goniometer in degrees.

Trial Locations

Locations (3)

Tampere Univeristy Hospital; 🇫🇮 Tampere, Finland

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland

Satakunta Central Hospital; 🇫🇮 Pori, Finland