Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up

Last updated: May 10, 2022
Sponsor: Olof Skoldenberg
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Complex Regional Pain Syndrome- Type 1 (Crps-i)

Tendon Injuries

Treatment

N/A

Clinical Study ID

NCT05371938
Handledsstudien 1
  • Ages 20-74
  • All Genders

Study Summary

A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or external fixation.

Eligibility Criteria

Inclusion

Inclusion Criteria: DS center

  • acute unilateral dorsally displaced distal radius fracture with a axial shortening ofat least 4 mm or a dorsal displacement of at least 20 degrees.
  • Age 20-70 SÖS center
  • Age 50-74 for women and 60-74 for men
  • injury only after fall from a standing height
  • wrist radiography of at least 20 degrees dorsal dislocation and/or at least 5 mm axialshortening
  • good knowledge of written and spoken swedish
  • fracture diagnosed within 72 hours from injury
  • patient resident within the catchment area of SÖS center

Exclusion

Exclusion Criteria: DS center:

  • no previous fracture of either wrist
  • ipsilateral acute fracture of the upper extremity
  • medicated with warfarin
  • unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness,language problems)
  • open fracture
  • fracture that was not amenable by both methods (distal fragment to small or tocomminuted) SÖS center:
  • former disability of either wrist
  • other concomitant injuries
  • rheumatoid arthritis or other severe joint disorder
  • Dementia or pfeiffer score under 5 points
  • drug abuse, alcohol abuse or psychiatric disorder
  • dependency in activity of daily living
  • medical condition contradicting general anesthesia

Study Design

Total Participants: 203
Study Start date:
April 01, 2022
Estimated Completion Date:
October 31, 2023

Study Description

Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength).

Previous Clinical trials registration for the original studies this long-term follow up is a continuation on: NCT00989222, NCT01034943, NCT01035359

Connect with a study center

  • Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics

    Stockholm, 182 88
    Sweden

    Active - Recruiting

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