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The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.
The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident®System | Experimental | Trident® Ceramic Insert/Trident® AD HA Acetabular Shell |
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| ABC System | Experimental | Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell |
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| Control | Active Comparator | OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident® Ceramic Insert/Trident® AD HA Acetabular Shell | Device | Trident® Ceramic Insert/Trident® AD HA Acetabular Shell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Component Revision and Complications | The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor | 3-5 and 10 Years |
| Radiographic Evaluation |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Capello, MD | Indiana University Medical Center | Study Chair |
| Benjamin Bierbaum, MD | New England Baptist Hospital | Principal Investigator |
| James D'Antonio, MD | Greater Pittsburgh Orthopaedic Associates | Study Chair |
| James Roberson, MD | Emory Orthopaedics Center | Principal Investigator |
| Scott Siverhus, MD | Toledo Joint Replacement and Orthopedic Center | Principal Investigator |
| Robert Zann, MD | Orthopaedic Surgery Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Surgery Associates | Boca Raton | Florida | 33435 | United States | ||
| Emory Univeristy |
There were 413/464 participants/hips enrolled. Started, completed and not completed counts are reported by hip.
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| ID | Title | Description |
|---|---|---|
| FG000 | Trident® System | Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head. |
| FG001 | ABC System | Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell | Device | Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell |
|
| OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell | Device | OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell |
|
Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm. |
| 3-5 and 10 years |
| Hip Follow-Up Questionnaire | A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as "satisfied" below); whether they have any study hip pain (noted as "no pain" below); and whether they have had any surgery on the study hip during the previous year noted as "no surgery" below). | 6-10 years |
| Atlanta |
| Georgia |
| 30329 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States |
| Toledo Joint Replacement and Orthopedic Center | Toledo | Ohio | 43623 | United States |
| Greater Pittsburgh Orthopaedics Assoc. | Moon Township | Pennsylvania | 15108 | United States |
| FG002 | Control | Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics are reported by hip for each arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trident System | Trident Ceramic Insert/Trident AD with PureFix HA Shell |
| BG001 | ABC System | Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell |
| BG002 | Control | Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | An approved protocol deviation allowed enrollment of a 12 y.o. female with juvenile RA. | Mean | Full Range | years |
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| Sex/Gender, Customized | Number | hips |
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| Region of Enrollment | Number | hips |
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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 | Component Revision and Complications | The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section. | Number of participants analyzed includes all subjects enrolled. | Posted | Number | hips | 10 years | hips | hips |
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| Secondary | Harris Hip Score | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor | Participants may have one or both hips replaced. Number of participants and hips analyzed include all enrolled. Number of hips with HHS evaluated at postoperative periods indicated is included in the outcome results posting. | Posted | Number | hips | 3-5 and 10 Years | Hips | Hips |
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| Secondary | Radiographic Evaluation | Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm. | Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips demonstrating radiographic failure assessment at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period. | Posted | Number | hips | 3-5 and 10 years | Hips | Hips |
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| Secondary | Hip Follow-Up Questionnaire | A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as "satisfied" below); whether they have any study hip pain (noted as "no pain" below); and whether they have had any surgery on the study hip during the previous year noted as "no surgery" below). | Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips with positive three question responses at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period. | Posted | Number | hips | 6-10 years | Hips | Hips |
|
10 years
Some participants were randomized to more than one hip system (17 participants/34 hips). Operative Site adverse events are reported by hip; systemic events are reported by participant. There were a total of 413 participants with 464 hips (190 Trident,185 ABC,89 Control) 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 | Trident® System | Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head. | 1 | 190 | 36 | 190 | ||
| EG001 | ABC System | Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head. | 1 | 185 | 17 | 185 | ||
| EG002 | Control | Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head. | 1 | 89 | 7 | 89 | ||
| EG003 | All Participants | All participants combined. | 1 | 413 | 0 | 413 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative Site Cardiac Disorders | Cardiac disorders | Non-systematic Assessment |
| ||
| Operative Site Musculoskeletal and Connective Tissue Disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative Site Musculoskeletal and Connective Tissue Disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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The disclosure restriction on the PI to publish results of this Clinical Study or the results of the activities hereunder, any abstract, manuscript, presentation or other communication shall be submitted to sponsor for review and approval at least 60 days prior to submission for publication. The sponsor retains the right to deny publication or, at its sole option, to revise the manuscript to delete proprietary or other confidential commercial information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Stryker Orthopaedics | 201-831-5401 | Ellen.Axelson@stryker.com |
| Male |
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| 0.1657 |
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