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NCT Number: NCT02879656

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

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

(i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE

(ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE

(iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture

(iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture

(v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures

(vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome

(vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS

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Key information

Conditions

Distal Radius Fracture Arm Injuries Fractures, Bone Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Viborg Regional Hospital, Viborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anterior radiographs in ER
  • >10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in the radiograph

Exclusion criteria

  • 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 or forearm

Treatment and study plan

Non-operative treatment

Procedure

conservative treatment with 5 weeks cast immobilization

Operative treatment

Procedure

surgery with volar locking plate with modified Henry's volar approach

Primary outcomes

  1. Change over time in Patient Rated Wrist Evaluation (PRWE)

    Time frame: 3 months, 1 year, 2 years

    PRWE 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.

Secondary outcomes

  1. 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.

  2. Quality of life measured with the 15-D

    Time frame: Baseline, 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.

  3. 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.

  4. Grip strength measured with a dynamometer

    Time frame: 3 months, 1 year

    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.

  5. 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.

  6. Physical activity measured with Axivity accelerometer

    Time frame: 3 months, 1 year

    Physical activity will be measured in a subgroup of patients in two separate follow-up time points.

  7. Self-assessment

    Time frame: Baseline, 1 year, 2 years

    Patient's self-assessment questionnaire will be analyzed to find out which parameters are of most importance for the patient.

  8. EWC

    Time frame: Baseline

    Edinbourgh wrist calculator will be used to estimate the propability of loss of reduction during the follow-up.

  9. Frailty

    Time frame: Baseline

    Clinical Frailty Score

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Central Finland Hospital District
  • Regionshospitalet Viborg, Skive
  • Satakunta Central Hospital

Registry information

Official study title

Non-operative Treatment Versus Surgery With Volar Locking Plate in Treatment of Distal Radius Fracture in 65-year-old and Older Patients - a Prospective, Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 26, 2016
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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