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

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

Conditions

• Distal Radius Fracture

Interventions

PROCEDURE

non-operative treatment

conservative treatment with 5 weeks cast immobilization

PROCEDURE

operative treatment

surgery with volar locking plate with modified Henry's volar approach

Sponsors & Collaborators

• Central Finland Hospital District

  collaborator OTHER

• Satakunta Central Hospital

  collaborator OTHER

• Regionshospitalet Viborg, Skive

  collaborator OTHER

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Ville Mattila, Prof · Tampere University Hospital

• Antti Launonen, MD · Tampere University Hospital

• Minna Laitinen, adjunct prof · Tampere University Hospital

• Teemu Hevonkorpi, MD · Tampere University Hospital

• Lauri Raittio, MD · Tampere University Hospital

• Toni Luokkala, MD · Central Finland Central Hospital

• Aleksi Reito, MD · Central Finland Central Hospital

• Juha Kukkonen, MD · Satakunta Central Hospital

• Li Felländer-Tsai, MD · Karolinska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-23

Primary Completion

2023-06-06

Completion

2023-06-06

Countries

• Denmark
• Finland
• Sweden

Study Locations