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.

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Key information

Conditions

Radial Head Fracture Arm Injuries Arthroplasty Complications Elbow Fracture Elbow Fractures Elbow Injuries Forearm Injuries Fractures, Bone Radial Head and Neck Fractures Radius Fractures Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

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.

Primary outcomes

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 outcomes

Pain

Time frame: 2-16 years postoperatively

Visual analogue scale. Range 0-10. Higher value indicate more intensive pain.
Range of motion

Time frame: 2-16 years postoperatively

Rang of elbow motion. Measured in grades. Supination, pronation, extension and flexion were measured.
Reoperation

Time frame: 2-16 years postoperatively

Number of patients needing revision surgery
Radiographic evaluation

Time frame: 2-16 years postoperatively

Radiographic evaluation of the prosthesis. The presence of radiolucent lines, loosening of the prosthesis.

Sponsors and collaborators

Lead sponsor

Sundsvall Hospital

Other

Registry information

Official study title

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

Acronym: RHA

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Dec 20, 2017
Registry last updated: Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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