Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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

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.

Condition or disease Intervention/treatment
Radial Head Fracture Elbow Fracture Arthroplasty Complications Procedure: Type of radial head arthroplasty

Layout table for study information
Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Radial Head Arthroplasty: A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : July 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
Bipolar radial head arthroplasty
Patients treated with bipolar head arthroplasty due to radial head fracture
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.

Unipolar radial head arthroplasty
Patients treated with unipolar head arthroplasty due to radial head fracture
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Pain [ Time Frame: 2-16 years postoperatively ]
    Visual analogue scale. Range 0-10. Higher value indicate more intensive pain.

  2. Range of motion [ Time Frame: 2-16 years postoperatively ]
    Rang of elbow motion. Measured in grades. Supination, pronation, extension and flexion were measured.

  3. Reoperation [ Time Frame: 2-16 years postoperatively ]
    Number of patients needing revision surgery

  4. Radiographic evaluation [ Time Frame: 2-16 years postoperatively ]
    Radiographic evaluation of the prosthesis. The presence of radiolucent lines, loosening of the prosthesis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03379935


Sponsors and Collaborators
Sundsvall Hospital
Investigators
Layout table for investigator information
Principal Investigator: Bakir Kadum, M.D, Ph.D Umeå University

Publications:
Layout table for additonal information
Responsible Party: Sundsvall Hospital
ClinicalTrials.gov Identifier: NCT03379935     History of Changes
Other Study ID Numbers: Radial head arthrplasty
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Researchers are welcome to ask for data. The corresponding author will provide this.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries