Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years

Last updated: May 12, 2024
Sponsor: Tampere University Hospital
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

operative treatment

non-operative treatment

Clinical Study ID

NCT02879656
R16105
  • Ages > 65
  • All Genders

Study Summary

The present collaboration study on the treatment of distal radius fractures is aimed to:

(i) to compare non-operative treatment to volar plating in the treatment of initially malaligned distal radius fractures in patients aged 65 and older in terms of functional outcome measured with PRWE

(ii) to compare non-operative treatment to volar plating in the treatment of distal radius fractures with early instability during follow-up, i.e., loss of reduction at 1 week (range 5 to 10 days) in patients aged 65 and older in terms of functional outcome measured with PRWE

(iii)to compare pain, disability, quality of life, grip strength, and the number of complications after non-operative treatment and the initial and delayed operative treatment of distal radius fracture

(iv) to assess the effect of pain catastrophizing score (PCS) on the functional outcome of non-operatively and operatively treated distal radius fracture

(v) to assess the association between physical activity and the number of wrist movements measured with Axivity accelerometer and functional outcome measured with PROMs of non-operatively and operatively treated distal radius fractures

(vi) to assess the effect of initial as well as the final radiological parameters on the functional outcome

(vii) to assess the correlation of probability of radiological malalignment estimated by clinical prediction rule (EWC) with functional outcome measured with PRWE and PASS

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • low energy intra or extra-articular dorsally displaced distal radius fracture within 3 cm of the radiocarpal joint, diagnosed with lateral and posterior-anteriorradiographs in ER

  • >10° dorsal tilt and/or over 2 mm step-off and/or over 3 mm shortening in theradiograph

Exclusion

Exclusion Criteria:

  • 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 or forearm

Study Design

Total Participants: 277
Treatment Group(s): 2
Primary Treatment: operative treatment
Phase:
Study Start date:
February 23, 2018
Estimated Completion Date:
June 06, 2023

Connect with a study center

  • Viborg Regional Hospital

    Viborg,
    Denmark

    Site Not Available

  • Jyväskylä Central Hospital

    Jyväskylä,
    Finland

    Site Not Available

  • Pori Central Hospital

    Pori,
    Finland

    Site Not Available

  • Tampere University Hospital

    Tampere, 33820
    Finland

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

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