- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121146
Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
November 3, 2014 updated by: C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
236
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Alexandria, Virginia, United States, 22306
- Anderson Orthopaedic Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Crosslinked Marathon polyethylene
|
Comparison of Marathon and Enduron polyethylene
|
ACTIVE_COMPARATOR: Standard Enduron polyethylene
|
Comparison of Marathon and Enduron polyethylene
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Clinically Significant Osteolysis
Time Frame: Minimum 9-year radiographic follow-up
|
The incidence of clinically significant osteolysis was based on the number of unrevised THAs (total hip arthroplasties) with at least 1.5 square centimeters of pelvic and/or femoral osteolysis.
Osteolysis was defined as an area of localized loss of trabecular bone or cortical erosion that was not apparent on the pre-operative or immediate postoperative radiograph.
To obtain lesion sizes, the defects were outlined on the anteroposterior pelvic radiograph and the area of the lesion was measured using Martell's Hip Analysis Suite software.
Lesions were considered clinically important if the total area of osteolysis around a hip replacement was at least 1.5 square centimeters.
|
Minimum 9-year radiographic follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Polyethylene Wear
Time Frame: Minimum 9-year radiographic follow-up
|
A single reviewer, who was blinded to the type of polyethylene liner, evaluated femoral head penetration among all unrevised hips with minimum 9-year radiographic follow-up using serial anteroposterior pelvic radiographs.
Two-dimensional head penetration was determined for each follow-up radiograph relative to the immediate post-operative (nominal 6-week follow-up) reference view using Hip Suite Analysis version 8.0 with elliptical correction, a validated, computer-assisted technique.
A linear wear rate was evaluated for each hip that had a minimum of three follow-up radiographs by using a least-squares linear regression to calculate the slope of the best-fit line for the wear vector magnitude versus time in situ data.
The slope from this regression represented the steady-state linear wear rate.
The steady-state linear wear rate data from all hips in a group was used to compute a mean polyethylene wear value.
|
Minimum 9-year radiographic follow-up
|
Rate of Reoperation
Time Frame: 10-year follow-up
|
The rate of reoperation was based on the number of reoperations in each group.
Any additional surgery after a participant's initial hip replacement was considered a reoperation.
|
10-year follow-up
|
Harris Hip Score
Time Frame: Minimum 9-year follow-up
|
The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best).
|
Minimum 9-year follow-up
|
Patient Satisfaction
Time Frame: Minimum 9-year follow-up
|
Patient satisfaction was quantified by asking participants to respond "yes" or "no" to the question, "Are you satisfied with the results of your hip operation?"
|
Minimum 9-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Charles A. Engh, Sr., MD, Anderson Orthopaedic Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1998
Primary Completion (ACTUAL)
March 1, 2012
Study Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
May 10, 2010
First Submitted That Met QC Criteria
May 11, 2010
First Posted (ESTIMATE)
May 12, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
November 5, 2014
Last Update Submitted That Met QC Criteria
November 3, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AORI2010-0100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthritis
-
Chang Gung Memorial HospitalNot yet recruitingArthritis Knee | Arthritis HipTaiwan
-
MedShape, IncSaint Alphonsus Medical GroupUnknownAnkle Arthritis | Foot ArthritisUnited States
-
Northumbria Healthcare NHS Foundation TrustUniversity of YorkRecruitingKnee Arthritis | Hip ArthritisUnited Kingdom
-
MedShape, IncOrthopedic Foot and Ankle Center, Ohio; CurveBeam LLCRecruitingAnkle Arthritis | Arthritis FootUnited States
-
MedShape, IncUniversity of Alabama at BirminghamRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
University of Alabama at BirminghamMedShape, IncRecruiting
-
MedShape, IncThe University of Texas Medical Branch, GalvestonRecruitingAnkle Arthritis | Foot ArthritisUnited States
-
Saint Alphonsus Regional Medical CenterCompletedArthritis Knee | Arthritis of HipUnited States
-
Sunnybrook Health Sciences CentreUniversity Health Network, Toronto; University of TorontoCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedJuvenile Idiopathic Arthritis | Arthritis, Septic | Arthritis, UnspecifiedFrance
Clinical Trials on Total Hip Replacement
-
The Royal Orthopaedic Hospital NHS TrustStryker NordicRecruitingPost-traumatic Osteoarthritis | Inflammatory Arthritis | Hip Osteoarthritis | Avascular Necrosis of Hip | Congenital Hip ProblemsUnited Kingdom
-
NHS LothianTerminatedHip FracturesUnited Kingdom
-
Western University, CanadaRecruiting
-
Zimmer BiometTerminatedJoint Diseases | Osteoarthritis, Hip | Avascular Necrosis of Hip | Congenital Dysplasia of the Hip | Degenerative Joint Disease of Hip | Rheumatoid Arthritis of Hip | Post-Traumatic Osteoarthritis of HipCanada
-
Smith & Nephew, Inc.TerminatedJoint DiseasesCanada, Germany, Belgium
-
Second Hospital of Shanxi Medical UniversityRecruitingTotal Hip ReplacementChina
-
Medical University of WarsawCompletedOsteoarthritis, Hip | Hip Arthritis | Gait, FrontalPoland
-
DePuy OrthopaedicsTerminatedOsteoarthritis | Post-traumatic Arthritis | Non-inflammatory Degenerative Joint DiseaseUnited States
-
Second Affiliated Hospital, School of Medicine,...Not yet recruiting
-
Association pour le Développement et l'Enseignement...RecruitingOsteoarthritis, HipFrance