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Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty (RHA)

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ClinicalTrials.gov Identifier: NCT03379935
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Sundsvall Hospital

Tracking Information
First Submitted Date December 4, 2017
First Posted Date December 20, 2017
Last Update Posted Date December 20, 2017
Actual Study Start Date January 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2017)
QuickDASH [ Time Frame: 2-16 years postoperatively ]
Patients reported outcome measure. An abbreviated version of the Disabilities the Arm, Shoulder and Hand (DASH) questionnaire. Higher score indicate a greater level of disability, lower scores indicate a lower level of disability. The score ranges from 0 (no disability) to 100 (most severe disability).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 17, 2017)
  • Pain [ Time Frame: 2-16 years postoperatively ]
    Visual analogue scale. Range 0-10. Higher value indicate more intensive pain.
  • Range of motion [ Time Frame: 2-16 years postoperatively ]
    Rang of elbow motion. Measured in grades. Supination, pronation, extension and flexion were measured.
  • Reoperation [ Time Frame: 2-16 years postoperatively ]
    Number of patients needing revision surgery
  • Radiographic evaluation [ Time Frame: 2-16 years postoperatively ]
    Radiographic evaluation of the prosthesis. The presence of radiolucent lines, loosening of the prosthesis.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
Official Title Radial Head Arthroplasty: A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
Brief Summary Fractures of the radial head are among the most common fractures in the elbow and represent one-third of all elbow fractures.This retrospective cohort study was performed between 2004 and 2014 at Sundsvall and Umeå University hospital, Sweden. All patients who were operated on between 2004 and 2014 with a radial head arthroplasty for an acute or sequelae due to a caput radii fracture.The aim of this study is to evaluate clinical or radiological differences between patients treated with a unipolar or bipolar radial head arthroplasty.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients treated with a radial head arthroplasty are included in the study. All patients were asked to participate in the follow-up during 2017.
Condition
  • Radial Head Fracture
  • Elbow Fracture
  • Arthroplasty Complications
Intervention Procedure: Type of radial head arthroplasty
Patiens are either treated with a unipolar or a bipolar radial head arthroplasty. At Sundsvall hospital all patients were treated with a unipolar and at Umeå university hospital all patients were treated with a bipolar arthroplasty.
Study Groups/Cohorts
  • Bipolar radial head arthroplasty
    Patients treated with bipolar head arthroplasty due to radial head fracture
    Intervention: Procedure: Type of radial head arthroplasty
  • Unipolar radial head arthroplasty
    Patients treated with unipolar head arthroplasty due to radial head fracture
    Intervention: Procedure: Type of radial head arthroplasty
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 17, 2017)
27
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2017
Actual Primary Completion Date July 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients treated with a radial head arthroplasty during the study period.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03379935
Other Study ID Numbers Radial head arthrplasty
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Researchers are welcome to ask for data. The corresponding author will provide this.
Responsible Party Sundsvall Hospital
Study Sponsor Sundsvall Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Bakir Kadum, M.D, Ph.D Umeå University
PRS Account Sundsvall Hospital
Verification Date December 2017