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Due to the pandemic, multiple sites were unable to complete patient visits resulting in less-than-optimal postoperative follow-up occurred. Therefore, study objectives were not met and the decision was made to close the study early.
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The success of the Triathlon Tritanium Knee will be determined by comparing the rate of absence of revision for aseptic loosening of the tibial baseplate at 2 years with the rates reported in the literature.
Cases are to be enrolled at five to ten centers. The same center may be included in both arms. Conversely, a center may choose to participate in only a single arm. The enrollment goal is approximately 36 - 72 cases per center for Cohort 1 (cementless) and 15 - 30 cases per center for Cohort 2 (cemented) , and will vary dependent upon the number of participating centers. Although a goal is presented, there is no maximum limit to the number of cases that a center may enroll. In the event that a center far exceeds the enrollment goal, Stryker may ask the center to cease enrollment so as not to skew the data. All participating centers will comply with the federal regulations regarding patient informed consent and Institutional Review Board (IRB) or Ethics Committee (EC) approval. Non-compliance of a study center may result in termination of the center's participation in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triathlon Tritanium Knee | Active Comparator | Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application. |
|
| Triathlon Knee | Active Comparator | Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon Tritanium Knee | Device | Cementless |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System | Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Survivorship (Baseplate and Patella) | This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Petrow, DO | Tucson Orthopaedic Institute | Principal Investigator |
| Alvin Ong, MD | Rothman Orthopaedic Institute | Principal Investigator |
| David Heekin, MD | Heekin Clinic | Principal Investigator |
| Kipling Sharpe, MD | OrthoArizona | Principal Investigator |
| Marcus Barnett, MD | Mission Hospital Research Institute | Principal Investigator |
| John Noble, MD | Imperial Health | Principal Investigator |
| Michael Masini, MD | St. Joseph Mercy Health System | Principal Investigator |
| Samuel Wellman, MD | Duke University | Principal Investigator |
| Ronald Delanois, MD | Sinai Hospital of Baltimore | Principal Investigator |
| Thomas Bowen, MD | Geisinger Orthopaedic Institute |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OrthoArizona | Gilbert | Arizona | 85234 | United States | ||
| Tucson Orthopaedic Institute |
Cohort 1: 397 participants/451 knees - 78 cases censored leaving 319 participants/373 knees.
Cohort 2: 216 participants/229 knees - 82 cases censored leaving 134 participants/147 knees.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 Cementless | Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application. It should be noted that Cohort 1 over-enrolled by 17 cases for a total of 373 cases. |
| FG001 | Cohort 2 Cemented | Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Includes all participants who received the Triathlon Knee System and were not censored from analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 Cementless | Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application. Triathlon Tritanium Knee: Cementless |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System | Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening. | The primary objective analysis only includes cementless, Cohort 1 participants. All Cohort 2 participants received cemented primary total knee replacements and are not included in the primary objective analysis. | Posted | Number | Successful Knees | 2 years | Knees | Knees |
|
Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
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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 | Cohort 1 Cementless | Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application. Triathlon Tritanium Knee: Cementless |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-operative | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Operative site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Events include arthrofibrosis, excessive knee pain, patellar fracture, soft tissue trauma, superficial wound infection, wound hematoma, tendinitis, IT band syndrome, effusion, swelling, bursitis, neuroma, lesion, bruising, incision dehiscence, etc. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stryker JR Clinical Research | Stryker Orthopaedics | 201-831-5000 | StrykerJRClinical@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jan 30, 2014 | Oct 25, 2018 | Prot_SAP_ICF_000.pdf |
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| Triathlon Knee |
| Device |
Cemented |
|
| Compare 2011 Knee Society Score (KSS) Scores Between Both Groups |
The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. |
| 2 years |
| Compare Oxford Knee Score (OKS) Scores Between Both Groups | The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. | 2 years |
| Compare Short Form-12 (SF-12) Scores Between Both Groups | The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state. | 2 years |
| Principal Investigator |
| Tucson |
| Arizona |
| 85741 |
| United States |
| Heekin Clinic | Jacksonville | Florida | 32204 | United States |
| Imperial Health | Lake Charles | Louisiana | 70605 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| St. Joseph Mercy Health System | Ypsilanti | Michigan | 48197 | United States |
| Rothman Orthopaedic Institute | Egg Harbor | New Jersey | 08234 | United States |
| Mission Hospital Research Institute | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27703 | United States |
| Geisinger Orthopaedic Institute | Danville | Pennsylvania | 17821 | United States |
| Revision of device |
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| Withdrawal by Subject |
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| Site termination |
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| Sponsor terminated study early |
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| Missed final 5-year protocol visit |
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| Censored because surgery cancelled |
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| Censored because study device was not implanted |
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| Censored because of inclusion/exclusion violation |
|
| BG001 |
| Cohort 2 Cemented |
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application. Triathlon Knee: Cemented |
| BG002 | Total | Total of all reporting groups |
| Knees |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| OG001 | Cohort 2 Cemented | Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application. |
|
|
| Secondary | Implant Survivorship (Baseplate and Patella) | This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination. | Results below are for the participants/knees that were measured and analyzed at 1-year, 3-year, 5-year, 7-year postoperative on Cohort 1 cementless only as per protocol. The final 10 year was not analyzed due to early study termination. | Posted | Number | 95% Confidence Interval | percentage of cementless knees | 10 years | Knees | Knees |
|
|
|
| Secondary | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups | The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. | Participants with available data at 2 years are presented for both cohorts. | Posted | Mean | Standard Deviation | units on a scale | 2 years | Knees | Knees |
|
|
|
| Secondary | Compare Oxford Knee Score (OKS) Scores Between Both Groups | The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes. | Participants with available data at 2 years are presented for both cohorts. | Posted | Mean | Standard Deviation | units on a scale | 2 years | Knees | Knees |
|
|
|
| Secondary | Compare Short Form-12 (SF-12) Scores Between Both Groups | The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state. | Participants with available data at 2 years are presented for both cohorts. | Posted | Mean | Standard Deviation | units on a scale | 2 years | Knees | Knees |
|
|
|
| 12 |
| 319 |
| 28 |
| 319 |
| 69 |
| 319 |
| EG001 | Cohort 2 Cemented | Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application. Triathlon Knee: Cemented | 0 | 134 | 8 | 134 | 12 | 134 |
| Non-operative | Gastrointestinal disorders | Non-systematic Assessment |
|
| 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 | Nervous system disorders | Non-systematic Assessment |
|
| Non-operative | Renal and urinary disorders | Non-systematic Assessment |
|
| Operative site | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Operative site | Surgical and medical procedures | Non-systematic Assessment |
|
|
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.
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| 3-year KM survival rate |
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| 5-year KM survival rate |
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| 7-year KM survival rate |
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| Patient Satisfaction Score |
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| Patient Expectation Score |
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