Overview

This trial is active, not recruiting.

Conditions osteoarthritis of hip, traumatic arthritis of hip
Treatment total hip arthroplasty
Sponsor Massachusetts General Hospital
Collaborator Biomet, Inc.
Start date November 2007
End date May 2023
Trial size 1000 participants
Trial identifier NCT00545285, 2007P001955

Summary

There are two distinct aims of this study:

1. This prospective study is designed to document the long-term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner which contains vitamin E as an anti-oxidant, (E-Poly), in a group of primary total hip arthroplasty subjects. The clinical outcome of E-Poly will be compared to a group of subjects receiving Arcom XL polyethylene.

2. This study is also designed to document the long-term (10-year) radiographic and clinical outcomes of a new cementless acetabular component having a titanium porous surface (Regenerex). The clinical outcome of this new FDA cleared device will be compared a group of subjects receiving an acetabular component having a plasma sprayed surface.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell
total hip arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
(Active Comparator)
Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell
total hip arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
(Active Comparator)
Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell
total hip arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
(Active Comparator)
Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell
total hip arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis

Primary Outcomes

Measure
Survivorship: length of time implant remains without revision
time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Complications and Adverse Events
time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Incidence of radiolucencies (acetabular component)
time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Patient administered Outcome Survey scores
time frame: Evaluated at 1,3,5,7 ,10th year over 10 years
Polyethylene wear rates from AP radiographs
time frame: Evaluated at 1,3,5,7 ,10th year over 10 years

Secondary Outcomes

Measure
Survivorship in subcategories of infection, aseptic loosening and other
time frame: 1,3,5,7,10 yr over 10 years
Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.
time frame: 1,3,5,7,10 yr over 10 years
Other outcomes that may be relevant.
time frame: 1,3,5,7,10 yr over 10 years
Retrieval analysis
time frame: 1,3,5,7,10 yr over 10 years

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion Criteria: - Subjects requiring primary total hip replacement - Subjects with diagnosis of osteoarthritis or traumatic arthritis - Subjects who demonstrate the ability to return for follow-up for the next 10 years Exclusion Criteria: - Subjects with limited life span - Subjects with difficulty in comprehending study protocol for any reason. - Subjects with inflammatory disease, previous infection or those requiring revision hip surgery. - Subjects with avascular necrosis - Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used. - Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia - Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity. - Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

Additional Information

Official title Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes
Principal investigator Henrik Malchau, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.