Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oulu
- Enrollment
- 80
- Primary Endpoint
- Difference of DASH-score between two study groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Volar plating
Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.
Intervention: Volar plating (Procedure)
Conservative treatment
Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.
Intervention: Conservative treatment (Procedure)
Outcomes
Primary Outcomes
Difference of DASH-score between two study groups
Time Frame: 2 year observation
Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity
Secondary Outcomes
- Difference of radiological parameters between two study groups(2 year observation)