Clinical trial NCT01121146: Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
Official title: A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Keywords: Osteolysis
Polyethylene
Crosslinked Polyethylene
Total Hip Replacement
CT
Lead sponsor: Anderson Orthopaedic Research Institute
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2010-05-12
Enrollment: 236
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in bone loss around the hip implant.

Detailed description: Several institutions report very low wear rates with highly crosslinked polyethylene based on early clinical data. However, since bone loss typically appears after 5-year follow-up, the reduction in the incidence and extent of bone loss among total hip replacement patients with crosslinked Marathon liners, compared to those with standard Enduron liners, has not been as dramatic as the wear reduction. Despite the substantial reduction in wear that we observed at 5-year follow-up, the patients' perceptions of their outcomes remained similar among the Marathon and Enduron groups. This study will evaluate outcome at a minimum of 10-years after surgery among the same group of patients whose outcome was previously reported at 5-year follow-up. At 10-year follow-up, we anticipate that the reduction in wear associated with Marathon polyethylene will be associated with significant reductions in bone loss when compared to the Enduron polyethylene.

Eligibility criteria: Inclusion Criteria:

(from original study)

-Elective total hip replacement patient

(from 10-year follow-up)

* Consented to the original study.
* Received a Duraloc 100 cup with either a crosslinked Marathon or standard Enduron liner.
* Received an AML/Solution or a Prodigy stem with 28mm cobalt chrome femoral head.

Exclusion Criteria:

(from original study)

-None

(from 10-year follow-up)

* Patient did not receive device as specified in inclusion criteria.
* Patient refused to consent to the 10-year follow-up.

Primary outcomes:
measure: Incidence of Clinically Significant Osteolysis
timeFrame: Minimum 9-year radiographic follow-up
Secondary outcomes:
measure: Polyethylene Wear
timeFrame: Minimum 9-year radiographic follow-up
measure: Rate of Reoperation
timeFrame: 10-year follow-up
measure: Harris Hip Score
timeFrame: Minimum 9-year follow-up
measure: Patient Satisfaction
timeFrame: Minimum 9-year follow-up
Other outcomes:
Locations:
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
Study officials:
affiliation: Anderson Orthopaedic Research Institute
name: Charles A. Engh, Sr., MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anderson Orthopaedic Research Institute
name: C. Anderson Engh, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leung SB, Egawa H, Stepniewski A, Beykirch S, Engh CA Jr, Engh CA Sr. Incidence and volume of pelvic osteolysis at early follow-up with highly cross-linked and noncross-linked polyethylene. J Arthroplasty. 2007 Sep;22(6 Suppl 2):134-9. doi: 10.1016/j.arth.2007.04.006. Epub 2007 Jul 27.
citation: Engh CA Jr, Stepniewski AS, Ginn SD, Beykirch SE, Sychterz-Terefenko CJ, Hopper RH Jr, Engh CA. A randomized prospective evaluation of outcomes after total hip arthroplasty using cross-linked marathon and non-cross-linked Enduron polyethylene liners. J Arthroplasty. 2006 Sep;21(6 Suppl 2):17-25. doi: 10.1016/j.arth.2006.05.002.