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.

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis of Hip; Traumatic Arthritis of Hip
• Intervention / Treatment: Procedure: Total Hip Arthroplasty

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Total hip Arthroplasty 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; Total hip Arthroplasty 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; Total hip Arthroplasty 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; Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell	Procedure: Total Hip Arthroplasty; Surgical implantation of specific hip replacement components for treatment of osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survivorship: length of time implant remains without revision	Evaluated at 1,3,5,7 ,10th year over 10 years
Complications and Adverse Events	Evaluated at 1,3,5,7 ,10th year over 10 years
Incidence of radiolucencies (acetabular component)	Evaluated at 1,3,5,7 ,10th year over 10 years
Patient administered Outcome Survey scores	Evaluated at 1,3,5,7 ,10th year over 10 years
Polyethylene wear rates from AP radiographs	Evaluated at 1,3,5,7 ,10th year over 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Survivorship in subcategories of infection, aseptic loosening and other	1,3,5,7,10 yr over 10 years
Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.	1,3,5,7,10 yr over 10 years
Other outcomes that may be relevant.	1,3,5,7,10 yr over 10 years
Retrieval analysis	1,3,5,7,10 yr over 10 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Henrik Malchau, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 15, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 17, 2007

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: total hip arthroplasty; survivorship; clinical outcomes; radiographic outcomes
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 2007P001955