Clinical Trial: Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Non-operative Treatment Versus Surgery With Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over Sixty Five Years- a Prospective, Randomized Controlled Trial

Brief Summary:

The present collaboration study on the treatment of distal radius fractures is aimed to:

(i) to compare the functional outcome in patient rated wrist evaluation (PRWE) score after closed reduction and cast immobilization and operative treatment with volar locking plate in the initial treatment of primarily unstable, non-reducible distal radius fractures in patients over 65 years.

(ii) to compare the functional outcome in PRWE score after closed reduction and cast immobilization and operative treatment with volar locking plate in the treatment distal radius fractures with early instability during follow-up, ie. loss of reduction at one week (5 to 10 days) in patients over 65 years.

(iii) to compare pain, disability, quality of life, grip strength and the number of complications after conservative treatment and initial and postponed operative treatment of distal radius fracture (iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of conservatively and operatively treated distal radius fracture

Detailed Summary:
Sponsor: Tampere University Hospital

Current Primary Outcome: Change over time in Patient Rated Wrist Evaluation (PRWE) [ Time Frame: 3 months, 1 year, 2 years ]

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: 3 months, 1 year, 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: 3 months, 1 year, 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: 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 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.
• Pain catastrophizing measured with the pain catastrophizing scale (PCS) [ Time Frame: baseline, 3 months, 1 year, 2 years ]
  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.

Original Secondary Outcome: Same as current

Information By: Tampere University Hospital

Dates:
Date Received: August 17, 2016
Date Started: September 2017
Date Completion: December 2020
Last Updated: December 6, 2016
Last Verified: December 2016