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Conservative Treatment vs. Volar Plating of Distal Radius Fractures (DRF)

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ClinicalTrials.gov Identifier: NCT02990052
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
University of Oulu

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

Condition or disease Intervention/treatment Phase
Distal Radius Fractures Procedure: Volar plating Procedure: Conservative treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
Study Start Date : November 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Volar plating
Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.
Procedure: Volar plating
Open reduction and volar fixed-angle plate fixation of distal radius fracture

Active Comparator: Conservative treatment
Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.
Procedure: Conservative treatment
Closed reduction & casting of distal radius fracture




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: University of Oulu
ClinicalTrials.gov Identifier: NCT02990052    
Other Study ID Numbers: Distal Radius Fr. Sirniö
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries