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NCT Number: NCT02894983

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

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.

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Key information

Conditions

Colles' Fracture Arm Injuries Distal Radius Fracture Fracture Dislocation Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures 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

Central Finland Central Hospital, Jyväskylä, Finland

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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 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

Treatment and study plan

Flexion-ulnar cast

Other

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.

Other names: Conservative treatment

Functional cast

Other

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.

Other names: Conservative treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Central Finland Hospital District
  • Satakunta Central Hospital

Registry information

Official study title

Comparison of Volar-flexion, Ulnar-deviation and Functional Position Cast Immobilization in the Non-operative Treatment of Distal Radius Fracture in Elderly Patients: a Pragmatic Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 9, 2016
Registry last updated
May 22, 2018

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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