Clinical trial NCT00545285: Long-Term Multi-center Evaluation of E-Poly and Regenerex
Official title: Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis of Hip
Traumatic Arthritis of Hip
Keywords: clinical outcomes
radiographic outcomes
total hip arthroplasty
survivorship
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2007-10-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Survivorship: length of time implant remains without revision
timeFrame: Evaluated at 1,3,5,7 ,10th year over 10 years
measure: Complications and Adverse Events
timeFrame: Evaluated at 1,3,5,7 ,10th year over 10 years
measure: Incidence of radiolucencies (acetabular component)
timeFrame: Evaluated at 1,3,5,7 ,10th year over 10 years
measure: Patient administered Outcome Survey scores
timeFrame: Evaluated at 1,3,5,7 ,10th year over 10 years
measure: Polyethylene wear rates from AP radiographs
timeFrame: Evaluated at 1,3,5,7 ,10th year over 10 years
Secondary outcomes:
measure: Survivorship in subcategories of infection, aseptic loosening and other
timeFrame: 1,3,5,7,10 yr over 10 years
measure: Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.
timeFrame: 1,3,5,7,10 yr over 10 years
measure: Other outcomes that may be relevant.
timeFrame: 1,3,5,7,10 yr over 10 years
measure: Retrieval analysis
timeFrame: 1,3,5,7,10 yr over 10 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Henrik Malchau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.