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

Osteoarthritis of Hip Clinical Trial

Official title:

Long-Term Multi-center Evaluation of E-Poly and Regenerex Cementless Acetabular Components: Clinical and Radiographic Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00545285
• Other study ID #: 2007P001955
• Status: Active, not recruiting
• Phase: N/A
• First received: October 15, 2007
• Last updated: May 2, 2017
• Start date: November 2007
• Est. completion date: May 2023

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Hip
• Osteoarthritis, Hip
• Traumatic Arthritis of Hip

Intervention

Procedure:
• Total Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivorship: length of time implant remains without revision		Evaluated at 1,3,5,7 ,10th year over 10 years
Primary	Complications and Adverse Events		Evaluated at 1,3,5,7 ,10th year over 10 years
Primary	Incidence of radiolucencies (acetabular component)		Evaluated at 1,3,5,7 ,10th year over 10 years
Primary	Patient administered Outcome Survey scores		Evaluated at 1,3,5,7 ,10th year over 10 years
Primary	Polyethylene wear rates from AP radiographs		Evaluated at 1,3,5,7 ,10th year over 10 years
Secondary	Survivorship in subcategories of infection, aseptic loosening and other		1,3,5,7,10 yr over 10 years
Secondary	Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.		1,3,5,7,10 yr over 10 years
Secondary	Other outcomes that may be relevant.		1,3,5,7,10 yr over 10 years
Secondary	Retrieval analysis		1,3,5,7,10 yr over 10 years