MedDataX Logo

Conservative Treatment vs. Volar Plating of Distal Radius Fractures

NCT ID: NCT02990052

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Radius Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Volar plating

Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.

Group Type ACTIVE_COMPARATOR

Volar plating

Intervention Type PROCEDURE

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

Conservative treatment

Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.

Group Type ACTIVE_COMPARATOR

Conservative treatment

Intervention Type PROCEDURE

Closed reduction \& casting of distal radius fracture

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Volar plating

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

Intervention Type PROCEDURE

Conservative treatment

Closed reduction \& casting of distal radius fracture

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Distal Radius Fr. Sirniö

Identifier Type: -

Identifier Source: org_study_id