Long-Term Multi-center Evaluation of E-Poly and Regenerex
NCT ID: NCT00545285
Last Updated: 2017-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2007-11-30
2023-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
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
2
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
3
Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell
Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
4
Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell
Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
Interventions
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Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
75 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Henrik Malchau
Director of Reseach
Principal Investigators
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Henrik Malchau, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Sillesen NH, Greene ME, Nebergall AK, Huddleston JI, Emerson R, Gebuhr P, Troelsen A, Malchau H. 3-year follow-up of a long-term registry-based multicentre study on vitamin E diffused polyethylene in total hip replacement. Hip Int. 2016 Jan-Feb;26(1):97-103. doi: 10.5301/hipint.5000297. Epub 2015 Dec 11.
Other Identifiers
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2007P001955
Identifier Type: -
Identifier Source: org_study_id
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