Triathlon Tritanium Knee Outcomes Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Triathlon Tritanium Knee 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. |
Device: Triathlon Tritanium Knee
Cementless
|
| Active Comparator: Triathlon Knee 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. |
Device: Triathlon Knee
Cemented
|
Outcome Measures
Primary Outcome Measures
- Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System [2 years]
Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.
Secondary Outcome Measures
- Implant Survivorship (Baseplate and Patella) [10 years]
This outcome measure will be entered at the 10-year time point.
- Compare 2011 Knee Society Score (KSS) Scores Between Both Groups [2 years]
The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, 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.
- Compare Oxford Knee Score (OKS) Scores Between Both Groups [2 years]
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.
- Compare Short Form-12 (SF-12) Scores Between Both Groups [2 years]
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 ragning from 0-100. Low values represent a poor health state and high values represent a good health state.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form.
-
Patient is a male or non-pregnant female age 18-75 years at time of study device implantation.
-
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
-
Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella.
-
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
-
Patient has a Body Mass Index (BMI) > 40.
-
Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
-
Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
-
Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
-
Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
-
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days).
-
Patient is diagnosed with lumbar radicular pain.
-
Patient has a known sensitivity to device materials.
-
Patient is a prisoner.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | OrthoArizona | Gilbert | Arizona | United States | 85234 |
| 2 | Tucson Orthopaedic Institute | Tucson | Arizona | United States | 85741 |
| 3 | Heekin Clinic | Jacksonville | Florida | United States | 32204 |
| 4 | Imperial Health | Lake Charles | Louisiana | United States | 70605 |
| 5 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
| 6 | St. Joseph Mercy Health System | Ypsilanti | Michigan | United States | 48197 |
| 7 | Rothman Orthopaedic Institute | Egg Harbor Township | New Jersey | United States | 08234 |
| 8 | Mission Hospital Research Institute | Asheville | North Carolina | United States | 28801 |
| 9 | Duke University Medical Center | Durham | North Carolina | United States | 27703 |
| 10 | Geisinger Orthopaedic Institute | Danville | Pennsylvania | United States | 17821 |
Sponsors and Collaborators
- Stryker Orthopaedics
Investigators
- Principal Investigator: 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
Study Documents (Full-Text)
More Information
Publications
None provided.- 74
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Cohort 1: 383 subjects/451 knees enrolled - 72 subjects/78 knees censored = 319 subjects/373 knees followed.Cohort 2: 205 subjects/229 knees enrolled - 75 subjects/82 knees censored = 134 subjects/147 knees followed.8 bilateral cases in Cohort 1 and 4 in Cohort 2 had 1 side censored and 1 side completed.These count in censored and followed counts. |
| Arm/Group Title | Cohort 1 Cementless | Cohort 2 Cemented |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Primary Objective | ||
| STARTED | 319 | 0 |
| COMPLETED | 259 | 0 |
| NOT COMPLETED | 60 | 0 |
| Period Title: Primary Objective | ||
| STARTED | 319 | 134 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 319 | 134 |
Baseline Characteristics
| Arm/Group Title | Cohort 1 Cementless | Cohort 2 Cemented | Total |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Total of all reporting groups |
| Overall Participants | 319 | 134 | 453 |
| Overall Knees | 373 | 147 | 520 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
62.46
(7.19)
|
63.07
(7.71)
|
62.64
(7.34)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
155
48.6%
|
57
42.5%
|
212
46.8%
|
| Male |
164
51.4%
|
77
57.5%
|
241
53.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
8
2.5%
|
1
0.7%
|
9
2%
|
| Not Hispanic or Latino |
299
93.7%
|
127
94.8%
|
426
94%
|
| Unknown or Not Reported |
12
3.8%
|
6
4.5%
|
18
4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
319
100%
|
134
100%
|
453
100%
|
Outcome Measures
| Title | Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System |
|---|---|
| Description | Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Cohort 1 Cementless | Cohort 2 Cemented |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 319 | 0 |
| Measure Knees | 373 | 0 |
| Number [Successful Knees] |
373
|
| Title | Implant Survivorship (Baseplate and Patella) |
|---|---|
| Description | This outcome measure will be entered at the 10-year time point. |
| Time Frame | 10 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Compare 2011 Knee Society Score (KSS) Scores Between Both Groups |
|---|---|
| Description | The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, 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. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Compare Oxford Knee Score (OKS) Scores Between Both Groups |
|---|---|
| Description | 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. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Compare Short Form-12 (SF-12) Scores Between Both Groups |
|---|---|
| Description | 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 ragning from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Adverse event data is provided from enrollment through the 2-year postoperative interval. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Cohort 1 Cementless | Cohort 2 Cemented | ||
| Arm/Group Description | 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 | 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 | ||
All Cause Mortality |
||||
| Cohort 1 Cementless | Cohort 2 Cemented | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/319 (0.9%) | 0/134 (0%) | ||
Serious Adverse Events |
||||
| Cohort 1 Cementless | Cohort 2 Cemented | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/319 (6.6%) | 8/134 (6%) | ||
| Blood and lymphatic system disorders | ||||
| Blood and lymphatic system disorders - Systemic | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Cardiac disorders | ||||
| Cardiac disorders - Systemic | 2/319 (0.6%) | 2 | 2/134 (1.5%) | 2 |
| Gastrointestinal disorders | ||||
| Gastrointestinal disorders - Systemic | 3/319 (0.9%) | 3 | 0/134 (0%) | 0 |
| Infections and infestations | ||||
| Loosening Femoral Component | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Injury, poisoning and procedural complications - Wound Related | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Injury, poisoning and procedural complications - Systemic | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Deep Joint Infection | 0/319 (0%) | 0 | 1/134 (0.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthrofibrosis | 7/319 (2.2%) | 7 | 2/134 (1.5%) | 2 |
| Excessive Knee Pain | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Musculoskeletal and connective tissue disorders - Wound Related | 1/319 (0.3%) | 1 | 1/134 (0.7%) | 1 |
| Tibial Component Loosening | 1/319 (0.3%) | 1 | 1/134 (0.7%) | 1 |
| Loosening Patellar Component | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Musculoskeletal and connective tissue disorders - Operative Site Other | 0/319 (0%) | 0 | 1/134 (0.7%) | 1 |
| Nervous system disorders | ||||
| Nervous system disorders - Systemic | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Peroneal Nerve Palsy | 0/319 (0%) | 0 | 1/134 (0.7%) | 1 |
| Renal and urinary disorders | ||||
| Renal and urinary disorders - Systemic | 3/319 (0.9%) | 3 | 0/134 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Soft Tissue Trauma | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
| Skin and subcutaneous tissue disorders - Wound Related | 1/319 (0.3%) | 1 | 0/134 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Cohort 1 Cementless | Cohort 2 Cemented | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 51/319 (16%) | 12/134 (9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal and connective tissue disorders - operative site | 51/319 (16%) | 66 | 12/134 (9%) | 16 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Ellen Axelson, Director, Clinical Operations |
|---|---|
| Organization | Stryker Orthopaedics |
| Phone | 201-831-5401 |
| ellen.axelson@stryker.com |
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