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

NCT02894983 | Completed

• 1 other identifier: R16035
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

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.

Conditions

Colles' Fracture; Distal Radius Fracture

Keywords

wrist fracture; colles fracture; non-operative; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Patient Rated Wrist Evaluation (PRWE) measure 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.

  2 years

Secondary Outcomes (6)

• Disability of the wrist measured with the Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire.

  2 years

• Quality of life measured with the 15-D.

  2 years

• Pain measured in Visual Analogue Scale (VAS).

  Baseline, 3 months, 1 year, 2 years

• Range of motion (ROM) is measured with a goniometer

  3 months

• Grip strength is measured with a dynamometer

  3 months

Study Arms (2)

Arm 1

OTHER

Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Other: Flexion-ulnar cast

Arm 2

OTHER

Conservative treatment chosen by physician on-call for dorsally displaced radius fracture.

Other: Functional cast

Interventions

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.

Also known as: Conservative treatment

Arm 1

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.

Also known as: Conservative treatment

Arm 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tampere University Hospital: lead
• Central Finland Hospital District: collaborator
• Satakunta Central Hospital: collaborator

Study Sites (3)

Central Finland Central Hospital

Jyväskylä, Finland

Location

Satakunta Central Hospital

Pori, Finland

Location

Tampere Univeristy Hospital

Tampere, Finland

Location

Related Publications (3)

• Ax M, Reito A, Hevonkorpi TP, Palola V, Kukkonen J, Luokkala T, Laitinen MK, Launonen AP, Mattila VM. A comparison of the functional results and costs of functional cast and volar-flexion ulnar deviation cast at 2-year follow-up in 105 patients aged 65 and older with dorsally displaced distal radius fracture: A randomized controlled trial. PLoS One. 2023 Apr 6;18(4):e0283946. doi: 10.1371/journal.pone.0283946. eCollection 2023.

  PMID: 37023069 DERIVED

• Raittio L, Launonen AP, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Laitinen MK, Mattila VM. Two casting methods compared in patients with Colles' fracture: A pragmatic, randomized controlled trial. PLoS One. 2020 May 29;15(5):e0232153. doi: 10.1371/journal.pone.0232153. eCollection 2020.

  PMID: 32469881 DERIVED

• Raittio L, Launonen A, Hevonkorpi T, Luokkala T, Kukkonen J, Reito A, Sumrein B, Laitinen M, Mattila VM. 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 protocol. BMC Musculoskelet Disord. 2017 Sep 18;18(1):401. doi: 10.1186/s12891-017-1759-y.

  PMID: 28923035 DERIVED

MeSH Terms

Conditions

Colles' Fracture; Wrist Fractures

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Fracture Dislocation; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Radius Fractures; Fractures, Bone; Wrist Injuries; Arm Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ville Mattila, MD, Professor

  Tampere Univeristy Hospital

  STUDY DIRECTOR

• Antti Launonen, MD, PhD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 9, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

FI (3)