N/A
N=225
Marathon and Enduron Polyethylene at Long-Term Follow-up
Osteoarthritis · Arthritis · Joint Diseases · Musculoskeletal Diseases · Rheumatic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02508428 ↗Enrolled (actual)
225
Serious AEs
10.0%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Hips Surviving at 15 Years — 100; 86 percentage of hips surviving at 15-years — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hip Replacement with crosslinked Marathon polyethylene (Device); Hip Replacement with noncrosslinked Enduron polyethylene (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Anderson Orthopaedic Research Institute
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Hips Surviving at 15 Years |
100; 86 | <0.001 sig |
| SECONDARY Polyethylene Wear |
0.03; 0.25 | <0.001 sig |
| SECONDARY Incidence of Clinically Important Osteolysis Among Unrevised THAs |
1; 28 | <0.001 sig |
| SECONDARY Patients Who Answered "Yes" to the Question, "Are You Satisfied With the Results of Your Hip Operation?" |
53; 48 | 0.48 |
| SECONDARY Harris Hip Score |
96; 92 | .40 |
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.
Eligibility 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 continued follow-up.
Data sourced from ClinicalTrials.gov (NCT02508428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.