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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 7, 2016
First Posted Date  ICMJE December 12, 2016
Last Update Posted Date December 12, 2016
Study Start Date  ICMJE November 2008
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Conservative Treatment vs. Volar Plating of Distal Radius Fractures
Official Title  ICMJE Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Distal Radius Fractures
Intervention  ICMJE
  • Procedure: Volar plating
    Open reduction and volar fixed-angle plate fixation of distal radius fracture
  • Procedure: Conservative treatment
    Closed reduction & casting of distal radius fracture
Study Arms  ICMJE
  • Active Comparator: Volar plating
    Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.
    Intervention: Procedure: Volar plating
  • Active Comparator: Conservative treatment
    Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.
    Intervention: Procedure: Conservative treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02990052
Other Study ID Numbers  ICMJE Distal Radius Fr. Sirniö
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Oulu
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP