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The primary objective of the study is to demonstrate the linear wear rates of the Trident® X3 polyethylene insert are superior to a polyethylene control group wear rate at 5 years postoperative. This measurement will be evaluated by comparing digitized images of serial radiographs obtained over a follow-up period of 5-years.
The study is a prospective, multi-center, historical-controlled clinical evaluation of the Trident® X3 Polyethylene insert. The device is commercially available in the United States where the study is being conducted. The study device, the Stryker Orthopaedics Trident® X3 polyethylene insert, is used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices. The control device, the Stryker Orthopaedics N2VAC polyethylene insert, is also used for the replacement of the bearing surface of the acetabulum to relieve pain, instability, and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, trauma, or failure of other devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident® X3 Polyethylene Insert | Other | Participants who received the Trident® X3 Polyethylene Insert. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident® X3 Polyethylene Insert | Device | Trident® X3 Polyethylene Insert |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Linear Wear Rate at 5 Years | Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years | 5 years |
| Rate of Incidence of Revision of Component for Any Reason | Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head. | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| Linear Wear Rate of the Trident X3 Polyethylene Insert | Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James D'Antonio, MD | Greater Pittsburgh Orthopaedic Association | Study Chair |
| Benjamin Bierbaum, MD | New England Baptist Hospital Deptartment of Orthopaedics | Principal Investigator |
| Peter Bonutti, MD | Bonutti Clinic | Principal Investigator |
| William Capello, MD | Indiana University Medical Center | Principal Investigator |
| Michael Taunton, MD | Mayo Clinic Department of Orthopaedic Surgery | Principal Investigator |
| Robert Johnson, MD | University of Vermont College of Medicine Department of Orthopaedics & Rehabilitation | Principal Investigator |
| J. Wesley Mesko, MD | Michigan Orthopaedic Center | Principal Investigator |
| James R Roberson, MD | Emory Orthopaedics | Principal Investigator |
| John Wright, MD | New West Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30329 | United States | ||
| Bonutti Research Inc. |
250 participants/271 hips enrolled - 29 participants/31 hips censored= 221 participants/240 hips followed. There were 5 revisions, but one bilateral participant had one hip revised and the other hip completed the primary endpoint. This participant is counted as completed and not in the revision category.
For bilateral hip replacement participants, if one hip completed primary endpoint #1 the participant is counted as completed. If one hip was censored, but the other hip was not, the hip is counted as censored, but the participant is not.
| ID | Title | Description |
|---|---|---|
| FG000 | Trident® X3 Polyethylene Insert | Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes participants who received the Trident X3 polyetheylene insert and were not censored from analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Trident® X3 Polyethylene Insert | All subjects who recieved the Trident X3 insert. |
| 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 participants, age at the time of surgery for the first hip enrolled is used for the baseline measurement. |
| 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 | Mean Linear Wear Rate at 5 Years | Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period of 5 years | Posted | Mean | Standard Deviation | mm/year | 5 years | Hips | Hips |
|
|
To 10 yrs postop. Initially, all AEs reported then modified to operative-site (serious/non-serious) and serious systemic. Yrs 6-10 op-site (serious/non-serious) & any AE deemed to be related or uncertain in relation to device.
Censored were not included as at risk. Industry Standard AE terms not used; specific AE terms not used for all AEs. Elective procedures not included eg. 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 Adverse Events | Trident X3 Polyethylene Insert. Operative site events are reported by hip because in the case of bilateral participants (this is when one participant has both hips enrolled in the study), an event can occur in one hip, both hips or the same hip at different times and are counted separately for this reason. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative Site | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative Site | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Stryker Orthopaedics | 201-831-5401 | Ellen.Axelson@stryker.com |
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| 2, 3 and 4 year films collected; 3 and 4 year wear assessed |
| Volumetric Wear Rate of the Trident X3 Polyethylene Insert | Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear. | 2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed |
| Radiographic Stability | Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years. | 1,2,3,4 and 5 years |
| Mean Harris Hip Score (HHS) to Assess Change | The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. 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 | pre-operative, 1,3 and 5 years |
| Mean Harris Hip Score (HHS) Pain Score to Assess Change | The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.
| pre-operative, 1,3, and 5 years |
| Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change | The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.
| pre-operative, 1,3 and 5 years |
| Mean SF-12 Health Survey Score to Assess Change | Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-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-operative, 1,3 and 5 years |
| Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change | Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. | pre-operative, 1,3 and 5 years |
| Implant Survivorship | Implant survivorship is determined using the Kaplan-Meier method. | 10 years |
| Daniel Ward, MD | New England Baptist Hospital Department of Orthopaedics | Principal Investigator |
| Russell Meldrum, MD | Indiana University Medical Center | Principal Investigator |
| J. Andrew Parr, MD | Indiana University Medical Center | Principal Investigator |
| Steven Incavo, MD | University of Vermont | Principal Investigator |
| Greg Erens, MD | Emory Orthopaedics | Principal Investigator |
| Robert Trousdale, MD | Mayo Clinic Department of Orthopaedic Surgery | Principal Investigator |
| Alren Hanssen, MD | Mayo Clinic Department of Orthopaedic Surgery | Principal Investigator |
| Effingham |
| Illinois |
| 62401 |
| United States |
| Indiana University | Indianapolis | Indiana | 46202-5111 | United States |
| New England Baptist Hospital | Boston | Massachusetts | 02120 | United States |
| J. Wesley Mesko, MD | Lansing | Michigan | 48910 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Good Samaritan Hospital | Kearney | Nebraska | 68845 | United States |
| Greater Pittsburgh Orthopaedics Assoc | Pittsburgh | Pennsylvania | 15108-4305 | United States |
| University of Vermont College of Medicine | Burlington | Vermont | 05405 | United States |
| Unable/Unwilling to Return/Withdrawal |
|
| Revision of study device |
|
| Site termination |
|
| No 5 yr x-rays |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hips |
|
|
| Primary | Rate of Incidence of Revision of Component for Any Reason | Revision of any component is defined as surgical removal and replacement of the femoral component, acetabular shell, acetabular insert and/or femoral head. | Difference of 5 participants from the participant flow completed (=110): 4 participants are included in the revision category of the participant flow and one participant had revision of only the femoral head & stem but later withdrew from the study & is included in the withdrawal category of the participant flow. | Posted | Number | percentage of hips undergoing revision | 5 year | Hips | Hips |
|
|
|
| Secondary | Linear Wear Rate of the Trident X3 Polyethylene Insert | Linear wear rates are defined as the annual rate of removal of the polyethylene from the polyethylene insert determined by comparing digitized images of serial radiographs obtained over the follow-up period. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear. | Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population. | Posted | Mean | Standard Deviation | mm/year | 2, 3 and 4 year films collected; 3 and 4 year wear assessed | Hips | Hips |
|
|
|
| Secondary | Volumetric Wear Rate of the Trident X3 Polyethylene Insert | Volumetric wear rate is calculated using a formula based on the cylindrical wear pattern perpendicular to the face of the cup and the mean linear wear rate. NOTE: 2 year linear and volumetric wear was not calculated for the following reason: To determine polyethylene wear, the total femoral head penetration is first calculated from the radiographs.The femoral head penetration has two components namely wear and creep (or bedding-in). It is not possible to separate the total penetration in to two components. The creep of the polyethylene starts from the date of surgery and continues up to 12-24 months. Therefore, the head penetration value at 2-years is dominated by Creep rather than wear. | Participants/hips with available data. Overall number of participants and units analyzed is based upon the 3 year population. | Posted | Number | cubic mm/year | 2, 3, 4 and 5 year films collected; 3, 4 and 5 year wear assessed | Hips | Hips |
|
|
|
| Secondary | Radiographic Stability | Radiographic stability is defined as having all of the following: no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire acetabular cup, no radiographic indication of acetabular cup migration of greater than or equal to 3 mm, no radiographic indication of progressive radiolucent lines greater than or equal to 2 mm around the entire femoral component, and no radiographic indication of progressive subsidence of the femoral component of greater than or equal to 5 mm. Radiographs are evaluated at 1,2,3,4 and 5 years. | Participants/hips with available data. Overall number of participants and units analyzed is based upon the 1 year population. | Posted | Number | hips evaluated as unstable on radiograph | 1,2,3,4 and 5 years | Hips | Hips |
|
|
|
| Secondary | Mean Harris Hip Score (HHS) to Assess Change | The change in HHS is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores that assess pain, function, joint deformity and range of motion. 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/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-operative, 1,3 and 5 years | Hips | Hips |
|
|
|
|
| Secondary | Mean Harris Hip Score (HHS) Pain Score to Assess Change | The change in HHS Pain is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative pain scores. Scores can range from 0 to 44, with 0 indicating totally disabling pain and 44 indicating no pain or pain that is ignored.
| 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-operative, 1,3, and 5 years | Hips | Hips |
|
|
|
|
| Secondary | Mean Harris Hip Score (HHS) Range of Motion (ROM) Score to Assess Change | The change in HHS ROM is reported by comparing the mean preoperative, 1, 3 and 5 year postoperative scores. Scores can range from 0 (worst) to 5 (best). The degrees of motion are measured for hip flexion, abduction, adduction, external rotation and internal rotation. The measured values are added to determine a combined value that is associated with a score from 0 to 5.
| 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-operative, 1,3 and 5 years | Hips | Hips |
|
|
|
|
| Secondary | Mean SF-12 Health Survey Score to Assess Change | Change in the SF-12 score is reported by comparing the mean preoperative, 1,3 and 5 year postoperative scores.The SF-12 Health Survey is a 12-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 units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-operative, 1,3 and 5 years | Hips | Hips |
|
|
|
|
| Secondary | Mean Lower Extremity Activity Scale (LEAS) Score to Assess Change | Change in the LEAS is reported by comparing the mean preoperative, 1,3 and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels are 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 units analyzed is based upon the preoperative population. | Posted | Mean | Standard Deviation | units on a scale | pre-operative, 1,3 and 5 years | Hips | Hips |
|
|
|
|
| Secondary | Implant Survivorship | Implant survivorship is determined using the Kaplan-Meier method. | Participants with available data. The population includes all 240 cases who were initially consented to 5 year study. There are 127 cases who consented to continue in the 10 year study. | Posted | Number | percentage of hips | 10 years | hips | hips |
|
|
|
| 12 |
| 240 |
| 62 |
| 240 |
| EG001 | Non-operative Adverse Events | Trident X3 Polyethylene Insert. Non-operative site events are reported by participant. | 33 | 221 | 65 | 221 |
| Non-operative Site | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-operative Site | General disorders | Non-systematic Assessment |
|
| Non-operative Site | Hepatobiliary disorders | Non-systematic Assessment |
|
| Operative Site | Infections and infestations | Non-systematic Assessment |
|
| Non-operative Site | Infections and infestations | Non-systematic Assessment |
|
| Operative Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative Site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Operative Site | Nervous system disorders | Non-systematic Assessment |
|
| Non-operative Site | Nervous system disorders | Non-systematic Assessment |
|
| Non-operative Site | Psychiatric disorders | Non-systematic Assessment |
|
| Non-operative Site | Renal and urinary disorders | Non-systematic Assessment |
|
| Non-operative Site | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Non-operative Site | Vascular disorders | Non-systematic Assessment |
|
| Non-operative Site | Infections and infestations | Non-systematic Assessment |
|
| Operative Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Non-operative Site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts and 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 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.
| 4 year mean wear rate |
|
|
| 4 year volumetric wear rate |
|
|
| 5 year volumetric wear rate |
|
|
| Radiographically unstable at 2 years |
|
|
| Radiographically unstable at 3 years |
|
|
| Radiographically unstable at 4 years |
|
|
| Radiographically unstable at 5 years |
|
|
| HHS Mean 1 Year Score |
|
|
| HHS Mean 3 Year Score |
|
|
| HHS Mean 5 year Score |
|
|
| <0.0001 |
| Superiority or Other |
| Change in HHS from pre-op to 5 years | t-test, 2 sided | <0.0001 | Superiority or Other |
| HHS Pain Mean 1 Year Score |
|
|
| HHS Pain Mean 3 Year Score |
|
|
| HHS Pain Mean 5 Year Score |
|
|
| <0.0001 |
| Superiority or Other |
| Change in Harris Hip Pain Score from pre-op to 5 years | Sign test | <0.0001 | Superiority or Other |
| HHS ROM Mean 1 Year Score |
|
|
| HHS ROM Mean 3 Year Score |
|
|
| HHS ROM Mean 5 Year Score |
|
|
| <0.0001 |
| Superiority or Other |
| Change in Harris Hip ROM score from pre-op to 5 years | Sign test | <0.0001 | Superiority or Other |
| Mean SF-12 Physical Score 1 year |
|
|
| Mean SF-12 Physical Score 3 years |
|
|
| Mean SF-12 Physical Score 5 years |
|
|
| Mean SF-12 Mental Score Preoperative |
|
|
| Mean SF-12 Mental Score 1 year |
|
|
| Mean SF-12 Mental Score 3 years |
|
|
| Mean SF-12 Mental Score 5 years |
|
|
| <0.0001 |
| Superiority or Other |
| Change in SF-12 Phyiscal Component Score from preop to 5 year | Sign test | <0.0001 | Superiority or Other |
| Change in SF-12 Mental Component Score from preop to 1 year | Sign test | 0.0242 | Superiority or Other |
| Change in SF-12 Mental Component Score from preop to 3 year | Sign test | 0.0247 | Superiority or Other |
| Change in SF-12 Mental Component Score from preop to 5 year | Sign test | 0.1372 | Superiority or Other |
| Mean LEAS score 1 year |
|
|
| Mean LEAS score 3 years |
|
|
| Mean LEAS score 5 years |
|
|
| <0.0001 |
| Superiority or Other |
| Change in LEAS Score from preop to 5 year | t-test, 2 sided | <0.0001 | Superiority or Other |
| Kaplan-Meier Estimate (based on 10 year cases) |
|
|