Knee ArthropathyHingeNCT06379321
Evaluation of Outcomes of the Triathlon Hinge Knee (THK) System
An observational study of Knee Arthropathy and Recurrence, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthropathy, Recurrence, Knee Infection
- What is being tested?
- Triathlon Hinge Knee (THK) System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2024to 10 May 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Participants who meet the eligibility criteria and receive/received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
Who may be able to join
- The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use.
- The subject has signed an Institutional Review Board (IRB)/Ethical Committee (EC)-approved, study-specific Informed Consent Form (ICF).
- The subject is a male or non-pregnant female at the time of enrollment.
- The subject agrees to comply with the protocol-mandated clinical evaluations.
Who cannot join
- Any active or suspected latent infection in or about the knee joint; overt infection;
- Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram;
- skeletally immature patients;
- Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- Known or suspected sensitivity and/or allergy to any material in the device.
Show all 15Show fewer
- Conditions presenting an increased risk of failure include:
- uncooperative patient or patient with neurologic disorder, incapable of following instructions;
- osteoporosis;
- metabolic disorders which may impair bone formation or cause bone loss;
- osteomalacia; and,
- previous arthrodesis.
- A higher incidence of implant failure has also occurred in paraplegics, cerebral palsy and patients with Parkinson's disease.
- Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- The subject is a prisoner
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Laura Stiegel, 216-442-5511, stiegel@ccf.org
Sanal Krishnan, 216-445-7194, krishns11@ccf.org
- Recruiting
Cleveland Clinic Florida
Weston, Florida, 33331
Kaitlin Bernabe, 954-610-8016, BERNABK@ccf.org
Jorge Manrique-Succar
About this study
Official title: A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System
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.
Read the detailed description
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.
- Conditions
- Knee Arthropathy, Recurrence, Knee Infection
- Being tested
- Triathlon Hinge Knee (THK) System
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triathlon Hinge Knee (THK) SystemDevice
Participants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use
| Study group | Role | What they receive |
|---|---|---|
| Primary | Triathlon Hinge Femoral Component + Revision Baseplate Receives: Device: Triathlon Hinge Knee (THK) System | |
| Revision | Triathlon Hinge Femoral Component+ Revision Baseplate Receives: Device: Triathlon Hinge Knee (THK) System | |
| 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 Receives: Device: Triathlon Hinge Knee (THK) System | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 2, 6 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start10 May 2024
- Primary completion10 May 2034 (estimated)
- Study completion10 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Nicolas Piuzzi, MD, Principal investigator, Associate Staff Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379321
- Sponsor's protocol ID
- 24-362
- Acronym
- Hinge
- Status last verified
- Feb 2026
- First submitted
- 18 Apr 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective/Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon Hinge Knee (THK) System
- ClinicalTrials.gov ID
- NCT06379321
- Acronym / sponsor ID
- Hinge / 24-362
- Conditions
- Knee Arthropathy, Recurrence, Knee Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- 10 May 2024 (actual)
- Primary completion
- 10 May 2034 (estimated)
- Study completion
- 10 May 2034 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Device: Triathlon Hinge Knee (THK) SystemTriathlon Hinge Femoral Component + Revision Baseplate |
| Revision | – | Device: Triathlon Hinge Knee (THK) SystemTriathlon Hinge Femoral Component+ Revision Baseplate |
| Total Stabilized (TS) Revision | – | –Triathlon Total Stabilized (TS) Femoral Component+ Revision Baseplate |
| Revision (Maximum of 80 subjects) | – | Device: Triathlon Hinge Knee (THK) SystemTriathlon 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 |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who meet the eligibility criteria and receive/received devices from the Triathlon Hinge Knee System according to its indications for use (IFU).
Key inclusion criteria (4 listed)
- The subject undergoes a primary or revision procedure implanting at least the Revision Baseplate portion of the Triathlon Hinge Knee System in accordance with the Indications for Use.
- The subject has signed an Institutional Review Board (IRB)/Ethical Committee (EC)-approved, study-specific Informed Consent Form (ICF).
- The subject is a male or non-pregnant female at the time of enrollment.
- The subject agrees to comply with the protocol-mandated clinical evaluations.
Key exclusion criteria (15 listed)
- Any active or suspected latent infection in or about the knee joint; overt infection;
- Distant foci of infection which may cause hematogenous spread to the implant site; rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram;
- skeletally immature patients;
- Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triathlon Hinge Knee (THK) SystemParticipants receive Triathlon Hinge Knee (THK) System during primary or revision knee arthroplasty in accordance with the indications for use | Device | Primary, Revision, Revision (Maximum of 80 subjects) |
Primary outcome
Survivorship
Time frame: 1, 2, 6 and 10 years
To evaluate the survivorship of the Hinge Knee System at postoperatively. Survival is defined as the absence of aseptic revision to the implanted device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Piuzzi, MD principal investigator
Associate Staff Orthopaedic Surgery
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Arthropathy and Recurrence, run by The Cleveland Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Stiegel (216-442-5511, stiegel@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship (time frame: 1, 2, 6 and 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.