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Polyethylene Liner

2 for Hip Osteoarthritis

N/A

Waitlist Available

Led By Henrik Malchau, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,3,5,7,10 yr over 10 years

Awards & highlights

Study Summary

This trial will compare the long-term effects of two different types of hip implants. One type of implant has a vitamin E-infused polyethylene liner, while the other has a titanium surface. The study will follow patients for ten years to track any differences in outcomes.

Eligible Conditions

Hip Osteoarthritis
Arthritis of Hip

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,3,5,7,10 yr over 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,3,5,7,10 yr over 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,3,5,7,10 yr over 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complications and Adverse Events

Incidence of radiolucencies (acetabular component)

Patient administered Outcome Survey scores

+2 more

Secondary outcome measures

Other outcomes that may be relevant.

Retrieval analysis

Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life.

+1 more

Trial Design

4Treatment groups

Active Control

Group I: 2Active Control1 Intervention

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

Group II: 4Active Control1 Intervention

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

Group III: 1Active Control1 Intervention

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

Group IV: 3Active Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,927 Previous Clinical Trials

13,197,181 Total Patients Enrolled

Zimmer BiometIndustry Sponsor

373 Previous Clinical Trials

66,395 Total Patients Enrolled

Henrik Malchau, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for the clinical trial still open?

"According to the clinicaltrials.gov database, this medical experiment is not presently enlisting candidates; however, there are 94 other trials which remain open for recruitment at present. The original posting date of this trial was November 1st 2007 and its latest update occurred on May 2nd 2017."

Answered by AI

What characteristics make someone an ideal candidate for enrollment in this investigation?

"For this medical trial, 1000 individuals between the ages of 20 and 75 with a diagnosis of osteoarthritis or traumatic arthritis in their hip can sign up. In order to participate, subjects must also be able to commit to 10 years of follow-up visits."

Answered by AI

Does this trial extend to individuals of advanced age?

"The parameters for this trial necessitate that enrollees are aged between 20 and 75. Separately, 7 trials cater to minors and 91 studies engage with people who have surpassed the age of 65."

Answered by AI

Recent research and studies

HIP InternationalJournal

3-year Follow-up of a Long-term Registry-based Multicentre Study on Vitamin E Diffused Polyethylene in Total Hip Replacement

Sillesen, Nanna H., Meridith E. Greene, Audrey K. Nebergall, James I. Huddleston, Roger Emerson, Peter Gebuhr, Anders Troelsen, and Henrik Malchau. 2015. “3-year Follow-up of a Long-term Registry-based Multicentre Study on Vitamin E Diffused Polyethylene in Total Hip Replacement”. HIP International. SAGE Publications. doi:10.5301/hipint.5000297.

clinicaltrials.govStudy

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

Henrik Malchau 2007. "Long-Term Multi-center Evaluation of E-Poly and Regenerex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00545285.