Overview

This trial is active, not recruiting.

Conditions osteoarthritis, hip, osteoarthritis
Treatment total hip arthroplasty
Sponsor Odense University Hospital
Collaborator Massachusetts General Hospital
Start date May 2009
End date April 2011
Trial size 130 participants
Trial identifier NCT02196792, 000000, project-ID S-20080151

Summary

The aim of this study is to investigate the wear of two different polyethylene liners (E-Poly and ArcomXL, Biomet inc.) of primary total hip arthroplasty. This study is divided into one main study and three sub-studies.

- The main study investigates the wear of the liner using radiostereometric analysis (RSA) with five years follow-up. A two year follow-up analysis will be reported.

- Other studies i) investigate the cup migration in respect to the pelvis between two different femoral head sizes (32- and 36-mm), ii) clinical outcome score (Harris Hip Score, SF-36, UCLA, EQ5D) will also be evaluated.

An explorative study will be conducted investigating the possibility of using a bi-plane technique as RSA to detect the rigid body segment of the hip with a reduction of roentgen dose.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
E-Poly™ polyethylene liner in a titanium total hip arthroplasty with 32- and 36-mm femoral head.
total hip arthroplasty E-Poly™ polyethylene liner
(Active Comparator)
ArcomXL® polyethylene liner in a titanium total hip arthroplasty with 32- and 36-mm femoral head.
total hip arthroplasty E-Poly™ polyethylene liner

Primary Outcomes

Measure
Change in liner wear from baseline to 5 year follow up
time frame: Baseline, 12 week , 1-, 2-, and 5-year

Secondary Outcomes

Measure
Change in cup migration form baseline to 5 year followup
time frame: Baseline, 12 week , 1-, 2-, and 5-year
Change in clinical outcome score from baseline to 5 year follow-up
time frame: Baseline, 12 week, 1- and 5 year

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

Inclusion Criteria: - Primary unilateral uncemented - Primary idiopathic arthritis, - 40 to70 years of age, - Cup-size of 54mm and above Exclusion Criteria: - Anteversion where non-standard stem can be used, - Dysplasia (Center-edge angle of Wiberg < 20 degree), - Malignant condition, Prior radiotherapy, Physical or psychological condition (stated in the department's standard operation procedure), - Complications during surgery (requiring screws in shell or femoral cerclage)

Additional Information

Official title Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial
Principal investigator Dennis B Nielsen, PhD. Student, Eng.
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Odense University Hospital.