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

Tampere University Hospital114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Colles' Fracture Distal Radius Fracture

Interventions

The group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Functional castOTHER

The group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Central Finland Central Hospital

Jyväskylä, Finland

Satakunta Central Hospital

Pori, Finland

Tampere Univeristy Hospital

Tampere, Finland

Outcomes

Primary Outcomes

Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study

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.

Time frame: 2 years

Secondary Outcomes

Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.

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.

Time frame: 2 years

Quality of life measured with the 15-D.

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.

Time frame: 2 years

Pain measured in Visual Analogue Scale (VAS).

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.

Time frame: Baseline, 3 months, 1 year, 2 years

Range of motion (ROM) is measured with a goniometer

The ROM of the wrist is measured on both hands with a handheld goniometer in degrees.

Time frame: 3 months

Grip strength is measured with a dynamometer

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.

Time frame: 3 months

The pain catastrophizing scale (PCS) is measured with a self-administered questionnaire.

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.

Time frame: 2 years