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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty Complications; Elbow Fracture; Radial Head Fracture
• Intervention / Treatment: Procedure: Type of radial head arthroplasty

• Study Type: Observational
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QuickDASH	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).	2-16 years postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sundsvall Hospital
• Investigators: Principal Investigator: Bakir Kadum, M.D, Ph.D, Umeå University

Publications and helpful links

General Publications

• Heijink A, Kodde IF, Mulder PGH, Veltman ES, Kaas L, van den Bekerom MPJ, Eygendaal D. Radial Head Arthroplasty: A Systematic Review. JBJS Rev. 2016 Oct 18;4(10):e3. doi: 10.2106/JBJS.RVW.15.00095.
• Heijink A, Kodde IF, Mulder PGH, Van Dijk CN, Eygendaal D. Cemented bipolar radial head arthroplasty: midterm follow-up results. J Shoulder Elbow Surg. 2016 Nov;25(11):1829-1838. doi: 10.1016/j.jse.2016.05.017. Epub 2016 Aug 9.
• Duckworth AD, Wickramasinghe NR, Clement ND, Court-Brown CM, McQueen MM. Radial head replacement for acute complex fractures: what are the rate and risks factors for revision or removal? Clin Orthop Relat Res. 2014 Jul;472(7):2136-43. doi: 10.1007/s11999-014-3516-y.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 17, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 17, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Radial head arthrplasty

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Researchers are welcome to ask for data. The corresponding author will provide this.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No