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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Functional Cast Position Compared to Flexion-ulnar Position in Conservative Treatment of Distal Radius Fracture in Elderly in a Pragmatic Randomized Controlled Trial

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 Summary:
Sponsor: Tampere University Hospital

Current Primary Outcome: Patient Rated Wrist Evaluation (PRWE) measure is the primary outcome measure of wrist pain and disability in the study [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire. [ Time Frame: 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.
  • Quality of life measured with the 15-D. [ Time Frame: 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.
  • Pain measured in Visual Analogue Scale (VAS). [ Time Frame: 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.
  • Range of motion (ROM) is measured with a goniometer [ Time Frame: 3 months ]
    The ROM of the wrist is measured on both hands with a handheld goniometer in degrees.
  • Grip strength is measured with a dynamometer [ Time Frame: 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. [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Tampere University Hospital

Dates:
Date Received: August 22, 2016
Date Started: June 2016
Date Completion: June 2019
Last Updated: November 8, 2016
Last Verified: November 2016