Marathon and Enduron Polyethylene at Long-Term Follow-up

NCT02508428 | Completed Results

• 1 other identifier: AORI2015-0100
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Keywords

Osteolysis; Polyethylene; Crosslinked Polyethylene; Total Hip Replacement; Marathon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Polyethylene Wear

  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)

• Incidence of Clinically Important Osteolysis Among Unrevised THAs

  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)

• Patients Who Answered "Yes" to the Question, "Are You Satisfied With the Results of Your Hip Operation?"

  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)

• Harris Hip Score

  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)

Study Arms (2)

Crosslinked Marathon polyethylene

ACTIVE COMPARATOR

The crosslinked Marathon polyethylene liners used for the primary total hip replacements in this study were treated with 5 Mrad (50 kGy) of gamma irradiation to induce crosslinking and then heated above the melting temperature (150 degrees Celsius) to eliminate free radicals. This manufacturing process was designed to improve the polyethylene's resistance to wear through increased crosslinking and eliminate free radicals that render it susceptible to oxidative degradation. These liners were machined and terminally sterilized with gas plasma, a noncrosslinking chemical surface treatment. These liners did not have had free radicals at the time of implantation and did not incorporate antioxidants.

Device: Hip Replacement with crosslinked Marathon polyethylene

Noncrosslinked Enduron polyethylene

ACTIVE COMPARATOR

The standard, noncrosslinked Enduron polyethylene liners used for the primary total hip replacements in this study were manufactured from the same polyethylene resin as the crosslinked Marathon liners but never irradiated. Like the Marathon components, these liners were machined and terminally sterilized with gas plasma, a noncrosslinking chemical surface treatment. Based on the manufacturing methods, these liners would not have had free radicals at the time of implantation and did not incorporate antioxidants.

Device: Hip Replacement with noncrosslinked Enduron polyethylene

Interventions

Hip Replacement with crosslinked Marathon polyethylene DEVICE

Comparison of Marathon and Enduron polyethylene

Crosslinked Marathon polyethylene

Hip Replacement with noncrosslinked Enduron polyethylene DEVICE

Noncrosslinked Enduron polyethylene

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (from original study)
• None
• (from 10-year follow-up)
• Patient refused to consent to continued follow-up.

Sponsors & Collaborators

• Anderson Orthopaedic Research Institute: lead
• DePuy Orthopaedics: collaborator

Study Sites (1)

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306, United States

Location

Related Publications (3)

• 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.

  PMID: 17823032 RESULT

• 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.

  PMID: 16950057 RESULT

• 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: 10.1016/j.arth.2012.03.048. Epub 2012 Jun 6.

  PMID: 22682044 RESULT

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteolysis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Bone Resorption; Bone Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

The main weakness of this study is the incomplete followup. We attribute the incomplete followup to the unfortunate reality that older patients are frequently unwilling or unable to obtain followup for a variety of reasons.

Results Point of Contact

• Title: C. Anderson Engh, Jr., MD
• Organization: Anderson Orthopaedic Research Institute

research@aori.org

703-619-4411

Study Officials

• C. Anderson Engh, Jr., MD

  Anderson Orthopaedic Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 27, 2015
• Study Start: January 6, 1999
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Locations

US (1)