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Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier:
NCT01121146
First received: May 10, 2010
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Device: Total Hip Replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Anderson Orthopaedic Research Institute:

Primary Outcome Measures:
  • Incidence of Clinically Significant Osteolysis [ Time Frame: Minimum 9-year radiographic follow-up ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Polyethylene Wear [ Time Frame: Minimum 9-year radiographic follow-up ] [ Designated as safety issue: Yes ]
    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.

  • Rate of Reoperation [ Time Frame: 10-year follow-up ] [ Designated as safety issue: Yes ]
    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.

  • Harris Hip Score [ Time Frame: Minimum 9-year follow-up ] [ Designated as safety issue: No ]
    The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best).

  • Patient Satisfaction [ Time Frame: Minimum 9-year follow-up ] [ Designated as safety issue: No ]
    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?"


Enrollment: 236
Study Start Date: December 1998
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Crosslinked Marathon polyethylene Device: Total Hip Replacement
Comparison of Marathon and Enduron polyethylene
Active Comparator: Standard Enduron polyethylene Device: Total Hip Replacement
Comparison of Marathon and Enduron polyethylene

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121146

Locations
United States, Virginia
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States, 22306
Sponsors and Collaborators
Anderson Orthopaedic Research Institute
DePuy Orthopaedics
Investigators
Principal Investigator: Charles A. Engh, Sr., MD Anderson Orthopaedic Research Institute
Principal Investigator: C. Anderson Engh, Jr., MD Anderson Orthopaedic Research Institute
  More Information

Publications:
Responsible Party: C. Anderson Engh, Jr., MD, Investigator, Anderson Orthopaedic Research Institute
ClinicalTrials.gov Identifier: NCT01121146     History of Changes
Other Study ID Numbers: AORI2010-0100
Study First Received: May 10, 2010
Results First Received: July 31, 2013
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Anderson Orthopaedic Research Institute:
Osteolysis
Polyethylene
Crosslinked Polyethylene
Total Hip Replacement
CT

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Osteoarthritis
Rheumatic Diseases
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on November 20, 2014