NCT02879656

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

Non-operative Treatment Versus Surgery With Volar Locking Plate in Treatment of Distal Radius Fracture in 65-year-old and Older Patients - a Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Tampere University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-02-23
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2016-08-26
• Last updated: 2025-04-30

Locations

5 sites across 3 countries: Denmark, Finland, Sweden