Marathon and Enduron Polyethylene at Long-Term Follow-up

Osteoarthritis Clinical Trial

Official title:

A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty at Long-Term Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508428
• Other study ID #: AORI2015-0100
• Status: Completed
• Phase: N/A
• Start date: January 6, 1999
• Est. completion date: June 22, 2017

Study information

• Verified date: November 2020
• Source: Anderson Orthopaedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in survivorship due to wear-related revisions at minimum 14-year follow-up and every 5 years after.

Description:

Several institutions have reported very low wear rates with crosslinked polyethylene based on early and midterm clinical data. However, since revisions associated with osteolysis typically occur after 10-year follow-up, the greatest benefits of the reduced wear associated with crosslinked polyethylene are expected to be reflected in lower revision rates for wear-related complications at long-term follow-up. While crosslinking has proven to substantially reduce polyethylene wear during the first decade in vivo, characterizing the long-term clinical performance of Marathon polyethylene remains important because crosslinking is accompanied by a reduction in the ultimate tensile strength, fatigue strength, and elongation to failure of ultra high molecular weight polyethylene. As a consequence, concerns have been expressed about the potential for the liner fracture, in vivo polyethylene oxidation or accelerated wear at long-term follow-up, the effects of femoral head roughening over time and the bioreactivity of crosslinked polyethylene debris particles. Ultimately, the best way to address these concerns is in the context of well-controlled, long-term clinical outcome studies. This study will evaluate outcome at a minimum of 14-years after surgery among the same group of patients whose outcome was previously reported at 10-year follow-up. As part of our efforts to follow patients throughout their lives to obtain long-term outcome data, we will continue to obtain routine follow-up every 5 years from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years). Because we anticipate that the reduced incidence of wear and osteolysis will result in a lower incidence of revision surgery among the patients randomized to Marathon liners, implant revision for reasons related to wear will be our primary outcome measure at long-term follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 22, 2017
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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 continued follow-up.

Related Conditions & MeSH terms

• Arthritis
• Collagen Diseases
• Joint Diseases
• Musculoskeletal Diseases
• Osteoarthritis
• Rheumatic Diseases

Intervention

Device:
• Hip Replacement with crosslinked Marathon polyethylene
Comparison of Marathon and Enduron polyethylene
• Hip Replacement with noncrosslinked Enduron polyethylene

Locations

Country	Name	City	State
United States	Anderson Orthopaedic Research Institute	Alexandria	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Anderson Orthopaedic Research Institute	DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

References & Publications (3)

Engh CA Jr, Hopper RH Jr, Huynh C, Ho H, Sritulanondha S, Engh CA Sr. A prospective, randomized study of cross-linked and non-cross-linked polyethylene for total hip arthroplasty at 10-year follow-up. J Arthroplasty. 2012 Sep;27(8 Suppl):2-7.e1. doi: 10.1 — View 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 Ar — View 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. Epub 2007 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Hips Surviving at 15 Years	Kaplan-Meier survivorship was calculated using revision for wear/osteolysis as an endpoint.	At 15-year follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years)
Secondary	Polyethylene Wear	A single reviewer, blinded to the type of polyethylene liner, evaluated femoral head penetration among all hips using serial anteroposterior pelvic radiographs. Two-dimensional head penetration was determined for each follow-up radiograph 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 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.	At minimum 14-year radiographic follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years)
Secondary	Incidence of Clinically Important Osteolysis Among Unrevised THAs	The incidence of clinically important osteolysis is 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 and lateral radiographs. The area of the osteolysis 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 on either the AP or lateral view.	At minimum 14-year radiographic follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years)
Secondary	Patients Who Answered "Yes" to the Question, "Are You Satisfied With the Results of Your Hip Operation?"	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?" Because some patients had both of their hips included in the study, these patients responded to the question, "Are you satisfied with the results of your hip operation?" for their right and left hips. As a consequence, the "Units Analyzed" is reported as hips while the "Number of Participants Analyzed" reflects the number of patients.	At minimum 14-year follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years)
Secondary	Harris Hip Score	The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best). The score includes assessments of pain, functional ability, deformity and range of motion.	At minimum 14-year follow-up and every 5 years after from the date of the patient's primary total hip arthroplasty for the duration of the patient's life or until revision of the polyethylene liner (estimated to be 25 years)