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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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This study is a prospectively and retrospectively enrolled, post-market, open-label, non-randomized, single institution evaluation of clinical outcomes of primary or revision knee surgery patients who meet the eligibility criteria and received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
Clinical evaluation for all cases will include data collection of patient demographics, surgical details, early postoperative status, functional and clinical outcomes, and survivorship at 1, 2, 6, and 10-years.
The purpose of this study is to evaluate the safety and performance of the Triathlon Hinge Knee System for both primary and revision cases in accordance with the Indications for Use.
The main objective of this study is to determine (1) mid- (5 year) and long-term (10 year) survivorship, and (2) drivers of failure for the Triathlon Hinge Knee (THK) hinge. Data from this study will be used to develop a predictive model to identify the most important factors in achieving fixation, including the role of augments, cones, thresholds for cement mantle thickness, and number of zones of fixation required for survivorship.
Survivorship is defined as the absence of aseptic revision to the implanted device.
The Triathlon Hinge Knee System consists of Triathlon Hinge femoral components, the Triathlon Revision baseplate, Triathlon Revision Tibial Augments, Triathlon Hinge Femoral Distal Augments, Triathlon Hinge Insert, Triathlon Revision Insert X3, and Triathlon Hinge Bumpers, Axle, Bushings, Tibial Sleeve, and Bearing component.
It is designed to be a single platform for revision, difficult primary, and limb salvage surgeries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary | Triathlon Hinge Femoral Component + Revision Baseplate |
| |
| Revision | Triathlon Hinge Femoral Component+ Revision Baseplate |
| |
| Total Stabilized (TS) Revision | Triathlon Total Stabilized (TS) Femoral Component+ Revision Baseplate | ||
| Revision (Maximum of 80 subjects) | Triathlon Total Stabilized (TS) Femoral Component + Revision Baseplate |
| |
| Modular Rotating Hinge (MRH) Revision | Modular Rotating Hinge (MRH) Femoral Component + Revision Baseplate | ||
| Global Modular Replacement System (GMRS) Primary or Revision | Global Modular Replacement System (GMRS) Femoral Component + Revision Baseplate |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triathlon Hinge Knee (THK) System | Device | Participants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship | To evaluate the survivorship of the Hinge Knee System at postoperatively. Survival is defined as the absence of aseptic revision to the implanted device. | 1, 2, 6 and 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who meet the eligibility criteria and receive/received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Stiegel | Contact | 216-442-5511 | stiegel@ccf.org | |
| Sanal Krishnan, PHD | Contact | 216-445-7194 | krishns11@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Piuzzi, MD | Associate Staff Orthopaedic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Recruiting | Weston | Florida | 33331 | United States |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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