Arthroplasty, Replacement, KneeNCT02155712

Triathlon Tritanium Knee Outcomes Study

A study testing Triathlon Tritanium Knee and Triathlon Knee in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Arthroplasty, Replacement, Knee
What is being tested?: Triathlon Tritanium Knee and Triathlon Knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 680 participants
Where: 10 sitesUnited States
Study dates: Oct 2014to 11 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

Show all 9Show fewer

Patient is diagnosed with lumbar radicular pain.
Patient has a known sensitivity to device materials.
Patient is a prisoner.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Mission Hospital Research Institute
Asheville, North Carolina, 28801
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Geisinger Orthopaedic Institute
Danville, Pennsylvania, 17821
Duke University Medical Center
Durham, North Carolina, 27703
Rothman Orthopaedic Institute
Egg Harbor, New Jersey, 08234
OrthoArizona
Gilbert, Arizona, 85234
Heekin Clinic
Jacksonville, Florida, 32204
Imperial Health
Lake Charles, Louisiana, 70605
Tucson Orthopaedic Institute
Tucson, Arizona, 85741
St. Joseph Mercy Health System
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Read the 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.

Conditions: Arthroplasty, Replacement, Knee
Being tested: Triathlon Tritanium Knee, Triathlon Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Triathlon Tritanium KneeDevice
Cementless
Triathlon KneeDevice
Cemented

Study groups in NCT02155712
Study group	Role	What they receive
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. Receives: Device: Triathlon Tritanium Knee
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. Receives: Device: Triathlon Knee

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years

Secondary outcomes (4)

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.
Measured: 10 years
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.
Measured: 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.
Measured: 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.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201411 Mar 2023

First posted4 Jun 2014 (estimated)
Study startOct 2014
Primary completion5 Apr 2018
Study completion11 Mar 2023

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 680 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02155712
Sponsor's protocol ID: 74
Status last verified: Oct 2023
First submitted: 2 Jun 2014
Last updated: 14 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Active, not recruitingPhase 4
Evaluation of Pain Treatment After Total Knee Arthroplasty
Pain
RecruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
Not yet recruitingPhase 2
Nutrition and Swelling
Postoperative Recovery, Total Knee Arthroplasty

All Arthroplasty, Replacement, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Triathlon Tritanium Knee Outcomes Study
ClinicalTrials.gov ID: NCT02155712
Acronym / sponsor ID: 74
Conditions: Arthroplasty, Replacement, Knee
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 680 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Oct 2014 (actual)
Primary completion: 5 Apr 2018 (actual)
Study completion: 11 Mar 2023 (actual)
First posted: 4 Jun 2014 (estimated)
Results: Posted 16 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Triathlon Tritanium Knee	Active comparator	Device: Triathlon Tritanium KneeCases 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	Device: Triathlon KneeEnrollment 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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.

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 Tritanium KneeCementless	Device	Triathlon Tritanium Knee
Triathlon KneeCemented	Device	Triathlon Knee

Primary outcome

Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System
Time frame: 2 years
Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.

4 secondary outcomes

Implant Survivorship (Baseplate and Patella)
Time frame: 10 years
Compare 2011 Knee Society Score (KSS) Scores Between Both Groups
Time frame: 2 years
Compare Oxford Knee Score (OKS) Scores Between Both Groups
Time frame: 2 years
Compare Short Form-12 (SF-12) Scores Between Both Groups
Time frame: 2 years

Results and safety

Results posted to the registry on 16 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1 Cementless	397	0
Cohort 2 Cemented	216	37

Primary outcome: Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System

Time frame: 2 years. Number. Unit: Successful Knees

Measure	Cohort 1 Cementless n = 319	Cohort 2 Cemented n = 0
Value	373	–

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Cementless	28 of 319 (8.8%)	69 of 319 (21.6%)	12 of 319
Cohort 2 Cemented	8 of 134 (6%)	12 of 134 (9%)	0 of 134

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Knee

Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Active, not recruitingPhase 4
Evaluation of Pain Treatment After Total Knee Arthroplasty
Pain
RecruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
Not yet recruitingPhase 2
Nutrition and Swelling
Postoperative Recovery, Total Knee Arthroplasty

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. This study is not recruiting at the moment.

Edward Petrow, DO principal investigator

Tucson Orthopaedic Institute

Alvin Ong, MD principal investigator

Rothman Orthopaedic Institute

David Heekin, MD principal investigator

Heekin Clinic

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Triathlon Tritanium Knee and Triathlon Knee in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 10 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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Yes. Results are posted in the registry (first posted 16 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02155712.

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 14 Nov 2023.