Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 1:04 AM
Study NCT ID:
NCT02879656
Status:
COMPLETED
Last Update Posted:
2025-04-30
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-operative Treatment Versus Volar Locking Plate in Treatment of Distal Radius Fracture in Patients Over 65 Years
Sponsor:
Tampere University Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
(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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: