Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03009890 |
Other study ID # |
NL56858.100.16 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2017 |
Est. completion date |
November 1, 2022 |
Study information
Verified date |
January 2023 |
Source |
JointResearch |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Objective: to compare the functional outcome after open reduction and internal fixation with
non-operative cast treatment for elderly patients with displaced intra-articular distal
radius fractures.
Description:
Rationale: there is no consensus about the optimal treatment of displaced intra-articular
distal radius fractures in elderly patients. To ensure optimal functional outcome there is a
tendency to operate. However, there is no evidence that supports the surgical treatment of
patients aged 65 years or older and in the absence of clinical trials it stays unclear how
elderly patients with intra-articular fractures should be treated.
Study design: multi-center randomized controlled trial with a non-inferiority design.
Economic evaluation alongside a randomized controlled multi-center trial.
Study population: all consecutive patients aged between 65 years and older with displaced
intra-articular (AO Type C) distal radius fractures, with a not acceptable reduction within 3
weeks following trauma.
Intervention: patients will be randomized between open reduction and internal fixation
(intervention group) and plaster immobilization (control group).
Main study parameters: the primary outcome will be evaluated after 1 year with the
Patient-Rated Wrist Evaluation score (PRWE). Secondary outcomes comprise other patient
reported outcome measures (PROM) including the Disability of the Arm, Shoulder and Hand
(DASH), Quality of life (EQ-5D) and Pain Catastrophizing Scale (PCS). Further outcome
measurements comprise a costs evaluation questionnaire, range of motion (ROM), grip strength,
radiographic parameters and Complications.