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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crosslinked Marathon polyethylene | Active Comparator |
| |
| Standard Enduron polyethylene | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Replacement | Device | Comparison of Marathon and Enduron polyethylene |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Minimum 9-year radiographic follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
(from original study)
-Elective total hip replacement patient
(from 10-year follow-up)
Exclusion Criteria:
(from original study)
-None
(from 10-year follow-up)
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| Name | Affiliation | Role |
|---|---|---|
| Charles A. Engh, Sr., MD | Anderson Orthopaedic Research Institute | Principal Investigator |
| C. Anderson Engh, Jr., MD | Anderson Orthopaedic Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anderson Orthopaedic Research Institute | Alexandria | Virginia | 22306 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17823032 | Result | 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. | |
| 16950057 | 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. |
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Six subjects (6 hips) who had consented to participate were excluded from the study at the time of surgery because they did not receive a hip implant consisting of a 28-mm femoral head and a Duraloc 100 cup with a 4-mm lateralized liner due to intra-operative hip stability, leg length or cup fixation issues.
Starting in January 1999 for a period of 18 months, patients were enrolled from an orthopaedic clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crosslinked Marathon Polyethylene | Implanted with a metal femoral head and a crosslinked polyethylene liner. |
| FG001 | Standard Enduron Polyethylene | Implanted with a metal femoral head and a non-crosslinked polyethylene liner. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | 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). | 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?" | Minimum 9-year follow-up |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Crosslinked Marathon Polyethylene | Total Hip Replacement : Comparison of Marathon and Enduron polyethylene |
| BG001 | Standard Enduron Polyethylene | Total Hip Replacement : Comparison of Marathon and Enduron polyethylene |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Minimum 9-year radiographs used to assess osteolysis were available for 79 unrevised hips with Marathon and 68 unrevised hips with Enduron polyethylene. | Posted | Number | unrevised THAs | Minimum 9-year radiographic follow-up |
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| Secondary | 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. | At least 3 head penetration measurements evaluated with Martell's Hip Suite Analysis software were available for 76 unrevised hips with Marathon and 66 unrevised hips with Enduron polyethylene. | Posted | Mean | Standard Deviation | millimeters per year | Minimum 9-year radiographic follow-up |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | All 116 hips randomized to Marathon polyethylene and all 114 hips randomized to Enduron polyethylene were included in the analysis population to determine the rate of reoperation. | Posted | Number | THAs | 10-year follow-up |
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| Secondary | Harris Hip Score | The Harris Hip Score measures outcome after hip replacement and is based on a scale from 0 (worst) to 100 (best). | Harris Hip Scores were evaluated for 74 unrevised hips with Marathon and 65 unrevised hips with Enduron polyethylene that had minimum 9-year follow-up and complete data to compute a score. | Posted | Mean | Standard Deviation | score on a 100 point scale | Minimum 9-year follow-up |
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| Secondary | 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?" | Satisfaction rates were evaluated among 84 participants with unrevised hips who had Marathon and 70 participants with unrevised hips who had Enduron polyethylene. These participants had minimum 9-year follow-up and responded to the question about satisfaction. | Posted | Number | percentage of participants | Minimum 9-year follow-up |
|
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Adverse event data was collected throughout the duration of the study. The mean follow-up for the participants who were not revised and did not pass away within 9 years of their hip replacement was 10 years.
Serious adverse events were collected by questioning study participants and reviewing medical records. The denominator for "Other (non-serious) Adverse Events" is listed as 0 because other (non-serious) Adverse Events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crosslinked Marathon Polyethylene | Implanted with a metal femoral head and a crosslinked polyethylene liner. | 2 | 116 | 0 | 0 | ||
| EG001 | Standard Enduron Polyethylene | Implanted with a metal femoral head and a non-crosslinked polyethylene liner. | 11 | 114 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dislocation and Reoperation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Revision due to Wear/Osteolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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The sponsor requires at least 30 days to review and comment on manuscripts before submission. For abstracts, the time frame for review is at least 10 days before submission. The sponsor will inform the investigator of any changes deemed necessary to preserve the confidentiality of proprietary information or to ensure scientific accuracy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| C. Anderson Engh, Jr., MD | AORI | 703-619-4411 | research@aori.org |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010014 | Osteolysis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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| Male |
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