Status unknownNCT00545285Updated May 3, 2017

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

An interventional study of Total Hip Arthroplasty in Osteoarthritis of Hip and Traumatic Arthritis of Hip, sponsored by Massachusetts General Hospital. Status unknown at 1 site in United States. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 1,000
Allocation: Non-randomized
Ages: 20 Years to 75 Years
Sex: All

Study 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.

Conditions studied

Osteoarthritis of Hip
Traumatic Arthritis of Hip

Browse trials for

Osteoarthritis, Hip 628

Keywords

clinical outcomes
radiographic outcomes
total hip arthroplasty
survivorship

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,000 participants (estimated)

Study arms

Active comparator
1
Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell
Procedure: Total Hip Arthroplasty
Active comparator
2
Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell
Procedure: Total Hip Arthroplasty
Active comparator
3
Total hip Arthroplasty E-Poly™ liner with Regenerex Ringloc +™ shell
Procedure: Total Hip Arthroplasty
Active comparator
4
Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell
Procedure: Total Hip Arthroplasty

Interventions

ProcedureTotal Hip Arthroplasty
Surgical implantation of specific hip replacement components for treatment of osteoarthritis

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Massachusetts General Hospital
Boston, Massachusetts 02114, United States

References and documents

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. PubMed 26692248 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00545285
Lead sponsor: Massachusetts General Hospital
Collaborators: Zimmer Biomet
Responsible party: Henrik Malchau (Director of Reseach, Massachusetts General Hospital) — Principal investigator
First posted: Oct 17, 2007
Start date: Nov 2007
Primary completion: May 2023 (estimated)
Completion: May 2023 (estimated)
Last update: May 3, 2017

Study contacts

Henrik Malchau, MD

principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Osteoarthritis, Hip→

Other studies from this sponsor

Massachusetts General Hospital

Start the discussion