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

Arthroplasty Complications Clinical Trial

— RHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379935
• Other study ID #: Radial head arthrplasty
• Status: Completed
• Phase: N/A
• First received: December 4, 2017
• Last updated: December 17, 2017
• Start date: January 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: December 2017
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Arthroplasty Complications
• Elbow Fracture
• Fractures, Bone
• Radial Head Fracture

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

References & Publications (3)

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. — View Citation

Heijink A, Kodde IF, Mulder PG, Veltman ES, Kaas L, van den Bekerom MP, Eygendaal D. Radial Head Arthroplasty: A Systematic Review. JBJS Rev. 2016 Oct 18;4(10). pii: 01874474-201610000-00001. doi: 10.2106/JBJS.RVW.15.00095. — View Citation

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. — View Citation

Outcome

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