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

NCT00545285 | Unknown

• 1 other identifier: 2007P001955
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

There are two distinct aims of this study:

1. 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. 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.

Conditions

Osteoarthritis of Hip; Traumatic Arthritis of Hip

Keywords

clinical outcomes; radiographic outcomes; total hip arthroplasty; survivorship

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (4)

1

ACTIVE COMPARATOR

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

Procedure: Total Hip Arthroplasty

2

ACTIVE COMPARATOR

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

Procedure: Total Hip Arthroplasty

3

ACTIVE COMPARATOR

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

Procedure: Total Hip Arthroplasty

4

ACTIVE COMPARATOR

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

Procedure: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty PROCEDURE

Surgical implantation of specific hip replacement components for treatment of osteoarthritis

1; 2; 3; 4

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 26692248 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Henrik Malchau, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Reseach

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 17, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)