Marathon and Enduron Polyethylene at Long-Term Follow-up
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Arthritis, Arthritis, Arthritis, Osteoarthritis (OA), Orthopedic, Rheumatology |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2017 |
| Start Date: | June 2015 |
| End Date: | December 2030 |
A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty at Long-Term Follow-up
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.
polyethylene liners show differences in survivorship due to wear-related revisions at minimum
14-year follow-up and every 5 years after.
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.
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.
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)
(from 10-year follow-up)
- Patient did not receive device as specified in inclusion criteria.
- Patient refused to consent to continued follow-up.
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