Trial Outcomes & Findings for Marathon and Enduron Polyethylene at Long-Term Follow-up (NCT NCT02508428)
NCT ID: NCT02508428
Last Updated: 2020-12-01
Results Overview
Kaplan-Meier survivorship was calculated using revision for wear/osteolysis as an endpoint.
COMPLETED
NA
230 participants
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)
2020-12-01
Participant Flow
Beginning in January of 1999 and continuing over an 18-month period, patients at our institution were enrolled in a prospective, randomized, Institutional Review Board approved study to compare the outcome of THA using XLPE or CPE liners.
All patients undergoing primary THA were eligible to participate in this study. A total of 226 patients (236 hips) consented to participate. Six patients (6 hips) were excluded at the time of their surgery because they were not implanted with the study components for reasons related to intra-operative hip stability.
Unit of analysis: hips
Participant milestones
| Measure |
Crosslinked Marathon Polyethylene
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Standard Enduron Polyethylene
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Overall Study
STARTED
|
114 116
|
111 114
|
|
Overall Study
COMPLETED
|
62 64
|
44 46
|
|
Overall Study
NOT COMPLETED
|
52 52
|
67 68
|
Reasons for withdrawal
| Measure |
Crosslinked Marathon Polyethylene
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Standard Enduron Polyethylene
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Overall Study
Death
|
32
|
33
|
|
Overall Study
Liner revised
|
3
|
19
|
|
Overall Study
Incomplete follow-up
|
17
|
15
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Crosslinked Marathon Polyethylene
n=116 hips
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Non-crosslinked Enduron Polyethylene
n=114 hips
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
Total
n=230 hips
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 10.6 • n=116 hips
|
62.0 years
STANDARD_DEVIATION 11.1 • n=114 hips
|
62.3 years
STANDARD_DEVIATION 10.8 • n=230 hips
|
|
Sex: Female, Male
Female
|
65 hips
n=116 hips
|
57 hips
n=114 hips
|
122 hips
n=230 hips
|
|
Sex: Female, Male
Male
|
51 hips
n=116 hips
|
57 hips
n=114 hips
|
108 hips
n=230 hips
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
186 pounds
STANDARD_DEVIATION 47 • n=116 hips
|
180 pounds
STANDARD_DEVIATION 40 • n=114 hips
|
183 pounds
STANDARD_DEVIATION 43 • n=230 hips
|
|
Body Mass Index (BMI)
|
28.6 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.5 • n=116 hips
|
27.9 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.1 • n=114 hips
|
28.2 kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 5.3 • n=230 hips
|
PRIMARY outcome
Timeframe: 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)Population: All 230 total hip replacements randomized to crosslinked Marathon or non-crosslinked Enduron liners.
Kaplan-Meier survivorship was calculated using revision for wear/osteolysis as an endpoint.
Outcome measures
| Measure |
Crosslinked Marathon Polyethylene
n=116 hips
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Non-crosslinked Enduron Polyethylene
n=114 hips
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Percentage of Hips Surviving at 15 Years
|
100 percentage of hips surviving at 15-years
Interval 100.0 to 100.0
|
86 percentage of hips surviving at 15-years
Interval 78.0 to 93.0
|
SECONDARY outcome
Timeframe: 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)Population: Hips with at least 3 serial anteroposterior pelvic radiographs that were revised or had minimum 14-year radiographic follow-up.
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.
Outcome measures
| Measure |
Crosslinked Marathon Polyethylene
n=46 hips
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Non-crosslinked Enduron Polyethylene
n=56 hips
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Polyethylene Wear
|
0.03 mm/yr
Standard Deviation 0.05
|
0.25 mm/yr
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: 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)Population: Unrevised hips that had minimum 14-year radiographic follow-up and revised hips that had a pre-revision radiograph available for analysis.
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.
Outcome measures
| Measure |
Crosslinked Marathon Polyethylene
n=49 hips
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Non-crosslinked Enduron Polyethylene
n=58 hips
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Incidence of Clinically Important Osteolysis Among Unrevised THAs
|
1 hips
|
28 hips
|
SECONDARY outcome
Timeframe: 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)Population: All patients with minimum 14-year follow-up who responded 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.
Outcome measures
| Measure |
Crosslinked Marathon Polyethylene
n=53 hips
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Non-crosslinked Enduron Polyethylene
n=49 hips
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Patients Who Answered "Yes" to the Question, "Are You Satisfied With the Results of Your Hip Operation?"
|
53 hips
|
48 hips
|
SECONDARY outcome
Timeframe: 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)Population: All hip replacements with minimum 14-year follow-up that had data to compute a 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.
Outcome measures
| Measure |
Crosslinked Marathon Polyethylene
n=37 hips
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Non-crosslinked Enduron Polyethylene
n=26 hips
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Harris Hip Score
|
96 units on a scale
Interval 76.0 to 98.0
|
92 units on a scale
Interval 74.0 to 95.0
|
Adverse Events
Crosslinked Marathon Polyethylene
Non-crosslinked Enduron Polyethylene
Serious adverse events
| Measure |
Crosslinked Marathon Polyethylene
n=116 participants at risk
Total Hip Replacement using a crosslinked Marathon polyethylene liner
|
Non-crosslinked Enduron Polyethylene
n=114 participants at risk
Total Hip Replacement using a noncrosslinked Enduron polyethylene liner
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Wear/Osteolysis without fracture
|
0.00%
0/116 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
8.8%
10/114 • Number of events 10 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
|
Musculoskeletal and connective tissue disorders
Recurrent Dislocation
|
2.6%
3/116 • Number of events 3 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
1.8%
2/114 • Number of events 2 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
|
Musculoskeletal and connective tissue disorders
Wear/Osteolysis with Fracture
|
0.00%
0/116 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
6.1%
7/114 • Number of events 7 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
|
Musculoskeletal and connective tissue disorders
Open reduction of dislocation
|
0.86%
1/116 • Number of events 1 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
0.00%
0/114 • Adverse event data was collected from date of surgery up to 17 years after surgery.
Reoperations were evaluated by reviewing medical records and asking patients if they had any additional surgery on their hip. Please note that adverse events are reported based on the number of hips enrolled in the study, not the number of patients. Ten patients had both of their hips included in the study including two who had both hips randomized to Marathon, three who had both hips randomized to Enduron and five who had one hip randomized to Marathon and the other randomized to Enduron.
|
Other adverse events
Adverse event data not reported
Additional Information
C. Anderson Engh, Jr., MD
Anderson Orthopaedic Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee Materials should be submitted to the sponsor for review at least thirty days before they are due to be submitted for publication. The sponsor will inform the authors of any changes deemed necessary to preserve confidentiality, protect intellectual property or ensure scientific accuracy and the authors agree to make these changes before submission.
- Publication restrictions are in place
Restriction type: OTHER