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

NCT02894983 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2018-05-22

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Central Finland Hospital District

    collaborator OTHER
  • Satakunta Central Hospital

    collaborator OTHER
  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Ville Mattila, MD, Professor · Tampere Univeristy Hospital

  • Antti Launonen, MD, PhD · Tampere University Hospital

  • Teemu Hevonkorpi, MBBS · Tampere University Hospital

  • Lauri Raittio, MBBS · Tampere University Hospital

  • Toni Luokkala, MD · Central Finland Central Hospital

  • Aleksi Reito, MD, PhD · Central Finland Central Hospital

  • Juha Kukkonen, MD, PhD · Satakunta Central Hospital

  • Minna Laitinen, Adjacent prof · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-04-30
Completion
2018-05-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02894983 on ClinicalTrials.gov