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

NCT03379935 | Completed

• 1 other identifier: Radial head arthrplasty
• Study Type: observational
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Radial Head Fracture; Elbow Fracture; Arthroplasty Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain

  2-16 years postoperatively

• Range of motion

  2-16 years postoperatively

• Reoperation

  2-16 years postoperatively

• Radiographic evaluation

  2-16 years postoperatively

Study Arms (2)

Bipolar radial head arthroplasty

Patients treated with bipolar head arthroplasty due to radial head fracture

Procedure: Type of radial head arthroplasty

Unipolar radial head arthroplasty

Patients treated with unipolar head arthroplasty due to radial head fracture

Procedure: Type of radial head arthroplasty

Interventions

Type of radial head arthroplasty PROCEDURE

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.

Bipolar radial head arthroplasty; Unipolar radial head arthroplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Sundsvall Hospital: lead

Related Publications (3)

• 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.

  PMID: 27792673 BACKGROUND

• 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.

  PMID: 27521138 BACKGROUND

• 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.

  PMID: 24549774 BACKGROUND

MeSH Terms

Conditions

Radial Head and Neck Fractures; Elbow Fractures

Condition Hierarchy (Ancestors)

Elbow Injuries; Arm Injuries; Wounds and Injuries; Radius Fractures; Forearm Injuries; Fractures, Bone

Study Officials

• Bakir Kadum, M.D, Ph.D

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 20, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12