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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02894983
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : May 22, 2018
Sponsor:
Collaborators:
Central Finland Hospital District
Satakunta Central Hospital
Information provided by (Responsible Party):
Teemu Hevonkorpi, Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Colles' Fracture Distal Radius Fracture Other: Flexion-ulnar cast Other: Functional cast Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Arm 1
Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.
Other: Flexion-ulnar cast
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 Name: Conservative treatment

Arm 2
Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.
Other: Functional cast
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 Name: Conservative treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894983


Locations
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Finland
Central Finland Central Hospital
Jyväskylä, Finland
Satakunta Central Hospital
Pori, Finland
Tampere Univeristy Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
Central Finland Hospital District
Satakunta Central Hospital
Investigators
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Study Director: Ville Mattila, MD, Professor Tampere Univeristy Hospital
Principal Investigator: Antti Launonen, MD, PhD Tampere University Hospital
Study Chair: Teemu Hevonkorpi, MBBS Tampere University Hospital
Study Chair: Lauri Raittio, MBBS Tampere University Hospital
Study Chair: Toni Luokkala, MD Central Finland Central Hospital
Study Chair: Aleksi Reito, MD, PhD Central Finland Central Hospital
Study Chair: Juha Kukkonen, MD, PhD Satakunta Central Hospital
Study Chair: Minna Laitinen, Adjacent prof Tampere University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Teemu Hevonkorpi, MBBS, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02894983    
Other Study ID Numbers: R16035
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Keywords provided by Teemu Hevonkorpi, Tampere University Hospital:
wrist fracture
colles fracture
non-operative
rehabilitation
Additional relevant MeSH terms:
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Colles' Fracture
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries
Fracture Dislocation
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Calpastatin
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action