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

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ClinicalTrials.gov Identifier: NCT00545285
Recruitment Status : Active, not recruiting
First Posted : October 17, 2007
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by (Responsible Party):
Henrik Malchau, Massachusetts General Hospital

October 15, 2007
October 17, 2007
May 3, 2017
November 2007
May 2023   (Final data collection date for primary outcome 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 ]
Same as current
Complete list of historical versions of study NCT00545285 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Long-Term Multi-center Evaluation of E-Poly and Regenerex
Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes

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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Osteoarthritis of Hip
  • Traumatic Arthritis of Hip
Procedure: Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
  • Active Comparator: 1
    Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell
    Intervention: Procedure: Total Hip Arthroplasty
  • Active Comparator: 2
    Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell
    Intervention: Procedure: Total Hip Arthroplasty
  • Active Comparator: 3
    Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell
    Intervention: Procedure: Total Hip Arthroplasty
  • Active Comparator: 4
    Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell
    Intervention: Procedure: Total Hip Arthroplasty
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
Same as current
May 2023
May 2023   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00545285
2007P001955
No
Not Provided
Not Provided
Henrik Malchau, Massachusetts General Hospital
Massachusetts General Hospital
Zimmer Biomet
Principal Investigator: Henrik Malchau, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP