Long-Term Multi-center Evaluation of E-Poly and Regenerex

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by (Responsible Party):
Henrik Malchau, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00545285
First received: October 15, 2007
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention
Osteoarthritis of Hip
Traumatic Arthritis of Hip
Procedure: Total Hip Arthroplasty

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Survivorship: length of time implant remains without revision [ Time Frame: Evaluated at 1,3,5,7 ,10th year over 10 years ] [ Designated as safety issue: No ]
  • Complications and Adverse Events [ Time Frame: Evaluated at 1,3,5,7 ,10th year over 10 years ] [ Designated as safety issue: Yes ]
  • Incidence of radiolucencies (acetabular component) [ Time Frame: Evaluated at 1,3,5,7 ,10th year over 10 years ] [ Designated as safety issue: No ]
  • Patient administered Outcome Survey scores [ Time Frame: Evaluated at 1,3,5,7 ,10th year over 10 years ] [ Designated as safety issue: No ]
  • Polyethylene wear rates from AP radiographs [ Time Frame: Evaluated at 1,3,5,7 ,10th year over 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survivorship in subcategories of infection, aseptic loosening and other [ Time Frame: 1,3,5,7,10 yr over 10 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Other outcomes that may be relevant. [ Time Frame: 1,3,5,7,10 yr over 10 years ] [ Designated as safety issue: No ]
  • Retrieval analysis [ Time Frame: 1,3,5,7,10 yr over 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: November 2007
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
E-Poly™ liner in a titanium plasma sprayed RingLoc® shell
Procedure: Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
Active Comparator: 2
ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell
Procedure: Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
Active Comparator: 3
E-Poly™ liner with Regenerex Ringloc +™ shell
Procedure: Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
Active Comparator: 4
ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell
Procedure: Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545285

Contacts
Contact: Henrik Malchau, MD 617-726-3866 hmalchau@partners.org
Contact: Charles R Bragdon, PhD 617-724-7544 cbragdon@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Henrik Malchau, MD, PhD         
Sub-Investigator: Charles Bragdon, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Biomet, Inc.
Investigators
Principal Investigator: Henrik Malchau, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Henrik Malchau, Director of Reseach, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00545285     History of Changes
Other Study ID Numbers: 2007P001955
Study First Received: October 15, 2007
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
clinical outcomes
radiographic outcomes
total hip arthroplasty
survivorship

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 01, 2014