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

Primary Purpose

Osteoarthritis of Hip, Traumatic Arthritis of Hip

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Hip focused on measuring clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell

Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell

Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell

Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell

Outcomes

Primary Outcome Measures

Survivorship: length of time implant remains without revision
Complications and Adverse Events
Incidence of radiolucencies (acetabular component)
Patient administered Outcome Survey scores
Polyethylene wear rates from AP radiographs

Secondary Outcome Measures

Survivorship in subcategories of infection, aseptic loosening and other
Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.
Other outcomes that may be relevant.
Retrieval analysis

Full Information

First Posted
October 15, 2007
Last Updated
May 2, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00545285
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There are two distinct aims of this study: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip, Traumatic Arthritis of Hip
Keywords
clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell
Arm Title
2
Arm Type
Active Comparator
Arm Description
Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell
Arm Title
3
Arm Type
Active Comparator
Arm Description
Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell
Arm Title
4
Arm Type
Active Comparator
Arm Description
Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell
Intervention Type
Procedure
Intervention Name(s)
Total Hip Arthroplasty
Intervention Description
Surgical implantation of specific hip replacement components for treatment of osteoarthritis
Primary Outcome Measure Information:
Title
Survivorship: length of time implant remains without revision
Time Frame
Evaluated at 1,3,5,7 ,10th year over 10 years
Title
Complications and Adverse Events
Time Frame
Evaluated at 1,3,5,7 ,10th year over 10 years
Title
Incidence of radiolucencies (acetabular component)
Time Frame
Evaluated at 1,3,5,7 ,10th year over 10 years
Title
Patient administered Outcome Survey scores
Time Frame
Evaluated at 1,3,5,7 ,10th year over 10 years
Title
Polyethylene wear rates from AP radiographs
Time Frame
Evaluated at 1,3,5,7 ,10th year over 10 years
Secondary Outcome Measure Information:
Title
Survivorship in subcategories of infection, aseptic loosening and other
Time Frame
1,3,5,7,10 yr over 10 years
Title
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
Title
Other outcomes that may be relevant.
Time Frame
1,3,5,7,10 yr over 10 years
Title
Retrieval analysis
Time Frame
1,3,5,7,10 yr over 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Malchau, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26692248
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.
Results Reference
derived

Learn more about this trial

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

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