OsteoarthritisNCT01121146
Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
A study testing Total Hip Replacement in people with Osteoarthritis and Arthritis, run by Anderson Orthopaedic Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in bone loss around the hip implant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Arthritis, Joint Diseases
- What is being tested?
- Total Hip Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (from original study)
- -None
- (from 10-year follow-up)
- Patient did not receive device as specified in inclusion criteria.
- Patient refused to consent to the 10-year follow-up.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306
About this study
Official title: A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in bone loss around the hip implant.
Read the detailed description
Several institutions report very low wear rates with highly crosslinked polyethylene based on early clinical data. However, since bone loss typically appears after 5-year follow-up, the reduction in the incidence and extent of bone loss among total hip replacement patients with crosslinked Marathon liners, compared to those with standard Enduron liners, has not been as dramatic as the wear reduction. Despite the substantial reduction in wear that we observed at 5-year follow-up, the patients' perceptions of their outcomes remained similar among the Marathon and Enduron groups. This study will evaluate outcome at a minimum of 10-years after surgery among the same group of patients whose outcome was previously reported at 5-year follow-up. At 10-year follow-up, we anticipate that the reduction in wear associated with Marathon polyethylene will be associated with significant reductions in bone loss when compared to the Enduron polyethylene.
- Being tested
- Total Hip Replacement
- Keywords
- Osteolysis, Polyethylene, Crosslinked Polyethylene, Total Hip Replacement, CT
- Medical subject headings
- Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ReplacementDevice
Comparison of Marathon and Enduron polyethylene
| Study group | Role | What they receive |
|---|---|---|
| Crosslinked Marathon polyethylene | Active comparator | Not described Receives: Device: Total Hip Replacement |
| Standard Enduron polyethylene | Active comparator | Not described Receives: Device: Total Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clinically Significant Osteolysis
The incidence of clinically significant osteolysis was 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 radiograph and the area of the lesion 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.
Measured: Minimum 9-year radiographic follow-up
Secondary outcomes (4)
Polyethylene Wear
A single reviewer, who was blinded to the type of polyethylene liner, evaluated femoral head penetration among all unrevised hips with minimum 9-year radiographic follow-up using serial anteroposterior pelvic radiographs. Two-dimensional head penetration was determined for each follow-up radiograph relative to the immediate post-operative (nominal 6-week follow-up) reference view 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 by 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.
Measured: Minimum 9-year radiographic follow-up
Rate of Reoperation
The rate of reoperation was based on the number of reoperations in each group. Any additional surgery after a participant's initial hip replacement was considered a reoperation.
Measured: 10-year follow-up
Harris Hip Score
The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best).
Measured: Minimum 9-year follow-up
Patient Satisfaction
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?"
Measured: Minimum 9-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startDec 1998
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anderson Orthopaedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Orthopaedics
- Responsible party
- Principal investigator, C. Anderson Engh, Jr., MD, Anderson Orthopaedic Research Institute
- Investigators
- Charles A. Engh, Sr., MD, Principal investigator, Anderson Orthopaedic Research InstituteC. Anderson Engh, Jr., MD, Principal investigator, Anderson Orthopaedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121146
- Sponsor's protocol ID
- AORI2010-0100
- Status last verified
- Nov 2014
- First submitted
- 10 May 2010
- Last updated
- 5 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 17823032Engh 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.
PubMed 16950057
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Study Comparing Marathon Polyethylene and Enduron Polyethylene Acetabular Liners Used in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT01121146
- Acronym / sponsor ID
- AORI2010-0100
- Keywords
- Osteolysis, Polyethylene, Crosslinked Polyethylene, Total Hip Replacement, CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Anderson Orthopaedic Research InstituteUniversity, hospital or other
- Collaborators
- DePuy Orthopaedics
- Study start
- Dec 1998
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Posted 5 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether crosslinked Marathon and standard Enduron polyethylene liners show differences in bone loss around the hip implant.
Detailed description
Several institutions report very low wear rates with highly crosslinked polyethylene based on early clinical data. However, since bone loss typically appears after 5-year follow-up, the reduction in the incidence and extent of bone loss among total hip replacement patients with crosslinked Marathon liners, compared to those with standard Enduron liners, has not been as dramatic as the wear reduction. Despite the substantial reduction in wear that we observed at 5-year follow-up, the patients' perceptions of their outcomes remained similar among the Marathon and Enduron groups. This study will evaluate outcome at a minimum of 10-years after surgery among the same group of patients whose outcome was previously reported at 5-year follow-up. At 10-year follow-up, we anticipate that the reduction in wear associated with Marathon polyethylene will be associated with significant reductions in bone loss when compared to the Enduron polyethylene.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crosslinked Marathon polyethylene | Active comparator | Device: Total Hip Replacement |
| Standard Enduron polyethylene | Active comparator | Device: Total Hip Replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- (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.
Key exclusion criteria (5 listed)
- (from original study)
- -None
- (from 10-year follow-up)
- Patient did not receive device as specified in inclusion criteria.
- Patient refused to consent to the 10-year follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ReplacementComparison of Marathon and Enduron polyethylene | Device | Crosslinked Marathon polyethylene, Standard Enduron polyethylene |
Primary outcome
Incidence of Clinically Significant Osteolysis
Time frame: Minimum 9-year radiographic follow-up
The incidence of clinically significant osteolysis was 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 radiograph and the area of the lesion 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.
4 secondary outcomes
Polyethylene Wear
Time frame: Minimum 9-year radiographic follow-up
Rate of Reoperation
Time frame: 10-year follow-up
Harris Hip Score
Time frame: Minimum 9-year follow-up
Patient Satisfaction
Time frame: Minimum 9-year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17823032Leung 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.
- Results publication: PubMed 16950057Engh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles A. Engh, Sr., MD principal investigator
Anderson Orthopaedic Research Institute
C. Anderson Engh, Jr., MD principal investigator
Anderson Orthopaedic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Replacement in people with Osteoarthritis and Arthritis, run by Anderson Orthopaedic Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Clinically Significant Osteolysis (time frame: Minimum 9-year radiographic follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01121146, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2014.