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Completed

NCT Number: NCT02990052

Conservative Treatment vs. Volar Plating of Distal Radius Fractures

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volar plating

Procedure

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

Conservative treatment

Procedure

Closed reduction & casting of distal radius fracture

Primary outcomes

  1. 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

  1. Difference of radiological parameters between two study groups

    Time frame: 2 year observation

    Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Acronym: DRF

Important dates

Study start
2008
Primary completion
2014
Study completion
2016
First posted
Dec 12, 2016
Registry last updated
Dec 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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