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The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.
Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.
Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.
Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.
It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.
The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Other | Trident® Tritanium™ Acetabular Shell used in revision total hip replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Device | Trident® Tritanium™ Acetabular Shell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation | 5 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor. | pre-op, 3 month, 1, 2, 3, 4, 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Malkani, MD | University of Louisville | Study Chair |
| Michael Masini, MD | St Joseph Mercy Hospital | Principal Investigator |
| Daniel Ward, MD | New England Baptist Hospital | Principal Investigator |
| Benjamin Bierbaum, MD | New England Baptist Hospital | Principal Investigator |
| Kirby Hitt, MD | Scott & White Memorial Hospital | Principal Investigator |
| Kenneth Greene, MD | Crystal Clinic | Principal Investigator |
| Jim Kudrna, MD | Illinois Bone & Joint Institute | Principal Investigator |
| Ivan Tomek, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Stephen Kantor, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Steven Barnett, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Specialty Institute | Orange | California | 92868 | United States | ||
| Heekin Institute for Orthopedic Research, Inc. |
241 patients/245 hips - 51 patients/52 hips censored = 190 patients/193 hips followed
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| ID | Title | Description |
|---|---|---|
| FG000 | Trident® Tritanium™ Acetabular Shell | Trident® Tritanium™ Acetabular Shell used in revision total hip replacement |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Change in SF-36 From Pre-operative to Post-operative Visits | The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | pre-op, 3 month, 1, 2, 3, 4, 5 years |
| Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones. | 3 month, 1, 2, 3, 4, 5 years |
| Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks. | 3 month, 1, 2, 3, 4, 5 years |
| Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. | pre-op, 3 month, 1, 2, 3, 4, 5 years |
| Orthopedic Specialty Institute |
| Principal Investigator |
| Carlos Higuera, MD | The Cleveland Clinic | Principal Investigator |
| Joseph Zuckerman, MD | NYU Hospital for Joint Diseases | Principal Investigator |
| Fredrick Jaffe, MD | NYU Hospital for Joint Diseases | Principal Investigator |
| Stephen Incavo, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Timothy Lovell, MD | Rockwood Clinic | Principal Investigator |
| Sean Scully, MD | Cedars Medical Center | Principal Investigator |
| Amar Ranawat, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Geoffrey Westrich, MD | Hospital for Special Surgery, New York | Principal Investigator |
| R D Heekin, MD | Heekin Institute for Orthopedic Research, Inc. | Principal Investigator |
| Bryce Allen, MD | Scott & White Memorial Hospital | Principal Investigator |
| Jacksonville |
| Florida |
| 32204 |
| United States |
| Cedars Medical Center | Miami | Florida | 33136 | United States |
| Illinois Bone & Joint Institute | Glenview | Illinois | 60025 | United States |
| University of Louisville, 201 Abraham Flexner Way, Suite 100 | Louisville | Kentucky | 40202 | United States |
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States |
| St Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| NYU Hospital for Joint Diseases | New York | New York | 10003 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Crystal Clinic | Akron | Ohio | 44333 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | United States |
| Rockwood Clinic | Spokane | Washington | 99202 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Participants who were not censored from analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Trident® Tritanium™ Acetabular Shell | Trident® Tritanium™ Acetabular Shell used in revision total hip replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For bilateral hip patients, the age at time of first study surgery is used. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation | No cases were pending revision. | Posted | Count of Units | hips | 5 years post-operative | hips | hips |
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| Secondary | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor. | Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 3 month, 1, 2, 3, 4, 5 years | hips | hips |
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| Secondary | Change in SF-36 From Pre-operative to Post-operative Visits | The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 3 month, 1, 2, 3, 4, 5 years | hips | hips |
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| Secondary | Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones. | Participants/hips are based on evaluable films for this data point. Overall number of participants and hips analyzed is based upon the 3 month population. | Posted | Count of Units | hips | 3 month, 1, 2, 3, 4, 5 years | hips | hips |
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| Secondary | Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks. | Participants/hips are based on evaluable films for this data point. Overall number of participants and hips is based upon the 3 month population. | Posted | Count of Units | hips | 3 month, 1, 2, 3, 4, 5 years | hips | hips |
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| Secondary | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. | Participants/hips with available data. Overall number of participants and hips analysed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-op, 3 month, 1, 2, 3, 4, 5 years | hips | hips |
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Reportable adverse events for this study include those that are serious or related to the device.
Censored protocol deviations were not included as at risk participants. Industry standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included. e.g.non-study joint replacement/revision, rotator cuff repair, carpal tunnel release, cataract, intra-ocular & bunion procedures, total shoulder repair, laminectomy, microdiscectomy, breast reduction, cervical spine fusion, & mid-foot/flat-foot surgery.
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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 | Operative Site Events | Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Operative site events are reported by hip. | 28 | 193 | 0 | 193 | ||
| EG001 | Non-operative Site Events | Trident® Tritanium™ Acetabular Shell used in revision total hip replacement. Non-Operative site events are reported by participant. | 41 | 190 | 0 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative site | Cardiac disorders | Non-systematic Assessment |
| ||
| Non-operative site | Gastrointestinal disorders | Non-systematic Assessment |
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| Non-operative site | General disorders | Non-systematic Assessment |
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| Non-operative site | Hepatobiliary disorders | Non-systematic Assessment |
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| Operative site | Infections and infestations | Non-systematic Assessment |
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| Non-operative site | Infections and infestations | Non-systematic Assessment |
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| Non-operative site | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Non-operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Non-operative site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Non-operative site | Nervous system disorders | Non-systematic Assessment |
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| Non-operative site | Renal and urinary disorders | Non-systematic Assessment |
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| Non-operative site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Non-operative site | Vascular disorders | Non-systematic Assessment |
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| Operative site | Vascular disorders | Non-systematic Assessment |
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Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts & abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to the submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Operations | Stryker Orthopedics | 201-831-5401 | ellen.axelson@stryker.com |
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