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Conservative Treatment vs. Volar Plating of Distal Radius Fractures

Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02990052
Acronym
DRF
Enrollment
80
Registered
2016-12-12
Start date
2008-11-30
Completion date
2016-01-31
Last updated
2016-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fractures

Brief summary

A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture

Detailed description

Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years. Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.

Interventions

PROCEDUREVolar plating

Open reduction and volar fixed-angle plate fixation of distal radius fracture

PROCEDUREConservative treatment

Closed reduction & casting of distal radius fracture

Sponsors

University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients over 50 years-old * primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2) * primary reduction of fracture is acceptable considering primary conservative treatment

Exclusion criteria

* bilateral and open fractures and fractures with neurovascular compromise * other major concurrent fracture necessitating treatment of any kind * patients under 50 years of age * previous ipsilateral distal radius fracture * inflammatory joint disease * significant radiocarpal-joint degeneration * patient's bad co-operation or major co-morbidity making an operation contraindicated

Design outcomes

Primary

MeasureTime frameDescription
Difference of DASH-score between two study groups2 year observationDisability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity

Secondary

MeasureTime frameDescription
Difference of radiological parameters between two study groups2 year observationDorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026