Radial Head Arthroplasty A Clinical and Radiological Comparison of Monopolar and Bipolar Radial Head Arthroplasty

Completed

• Conditions: Radial Head Fracture; Elbow Fracture; Arthroplasty Complications
• Interventions: Procedure: Type of radial head arthroplasty

• Registration Number: NCT03379935
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2017-07-01
• Study Completion: 2017-10-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-17
• Last Update Submitted: 2017-12-17
• Study First Posted: 2017-12-20
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unipolar radial head arthroplasty	Type of radial head arthroplasty	Patients treated with unipolar head arthroplasty due to radial head fracture
Bipolar radial head arthroplasty	Type of radial head arthroplasty	Patients treated with bipolar head arthroplasty due to radial head fracture

Primary Outcome Measures

Name	Time	Method
QuickDASH	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

Name	Time	Method
Pain	2-16 years postoperatively	Visual analogue scale. Range 0-10. Higher value indicate more intensive pain.
Range of motion	2-16 years postoperatively	Rang of elbow motion. Measured in grades. Supination, pronation, extension and flexion were measured.
Reoperation	2-16 years postoperatively	Number of patients needing revision surgery
Radiographic evaluation	2-16 years postoperatively	Radiographic evaluation of the prosthesis. The presence of radiolucent lines, loosening of the prosthesis.