ArthroplastyNCT02521103

Triathlon Tritanium Cone Augments Outcomes Study

A study testing Triathlon Tritanium Cone Augments in people with Arthroplasty and Replacement, run by Stryker Orthopaedics at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study was to evaluate the success rate of the Triathlon Tritanium Cone Augment with the Triathlon TS Total Knee System at 2 years postoperative, defined as absence of revision of the Femoral Cone Augment or Tibial Cone augment for aseptic loosening. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Knee
What is being tested?: Triathlon Tritanium Cone Augments
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 254 participants
Where: 9 sitesUnited States
Study dates: Aug 2015to 31 Mar 2028
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 years and older
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, skeletally mature and age 18 years or older at time of study device implantation.
Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
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) > 45.
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.
Patient 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 has a failed unicondylar knee prosthesis.
Patient has a known sensitivity to device materials.
Patient is a prisoner.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Rush University Medical Center
Chicago, Illinois, 60612
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
Rothman Institute
Egg Harbor, New Jersey, 08234
Bluegrass Orthopaedics
Lexington, Kentucky, 40509
The CORE Institute
Novi, Michigan, 48374
Providence Medical Research Center
Spokane, Washington, 99208
The Orthopaedic Center
Tulsa, Oklahoma, 74104
Michigan Heart, St. Joseph Health System
Ypsilanti, Michigan, 48197
Orlando Health
Zephyrhills, Florida, 33542

Other trials in United States

About this study

Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments

Read the detailed description

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative. The total enrollment goal for the study is 145 cases have received the Triathlon TS Total Knee System with a Triathlon Tritanium Cone Augment. Additionally, between 40-50 cases (within the study population) will receive the Triathlon TS Total Knee System with a Triathlon Tritanium Central Femoral Cone Augment.

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

What participants receive

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

Triathlon Tritanium Cone AugmentsDevice
The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in revision TKA.

Study groups in NCT02521103
Study group	Role	What they receive
Triathlon Tritanium Cone Augments	Other	Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment. Receives: Device: Triathlon Tritanium Cone Augments

What is being measured

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

Cases With Revision of the Femoral Cone Augment or Tibial Cone Augment for Aseptic Loosening.
The primary efficacy parameter is the revision/removal of femoral cone augment or tibial cone augment for aseptic loosening at 2 years postoperative. Success at 2 years is defined as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening within 2 years.
Measured: 2 year

Secondary outcomes (2)

Location and Severity of End-of-stem Pain.
End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain.
Pain for both the shin and thigh are identified using the following categories:
- no pain
- pain with extreme activity only
- pain with moderate activity
- pain with normal activity
- pain at rest
Measured: 2 year
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
The AORI is a bone defect classification which consists of four Types:
Type I: Metaphyseal bone is intact, with minor bone defects not compromising component stability.
Type IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed.
Type IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed.
Type III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed.
Measured: Intraoperative

Timeline

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

Aug 201531 Mar 2028

First posted13 Aug 2015 (estimated)
Study startAug 2015
Primary completion31 Mar 2025
Study completion31 Mar 2028 (estimated)

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 ArthroplastyStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 254 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02521103
Sponsor's protocol ID: 76
Status last verified: Dec 2025
First submitted: 31 Jul 2015
Last updated: 1 Jun 2026
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

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All Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon TS Total Knee System With Triathlon Tritanium Cone Augments
ClinicalTrials.gov ID: NCT02521103
Acronym / sponsor ID: 76
Conditions: Arthroplasty, Replacement, Knee
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 254 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Aug 2015
Primary completion: 31 Mar 2025 (actual)
Study completion: 31 Mar 2028 (estimated)
First posted: 13 Aug 2015 (estimated)
Results: Posted 1 Jun 2026

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Triathlon Tritanium Cone Augments	Other	Device: Triathlon Tritanium Cone AugmentsCases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment.

Who may qualify

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

Key inclusion criteria (4 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, skeletally mature and age 18 years or older at time of study device implantation.
Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Key exclusion criteria (8 listed)

Patient has a Body Mass Index (BMI) > 45.
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.
Patient 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).

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 Cone AugmentsThe Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in revision TKA.	Device	Triathlon Tritanium Cone Augments

Primary outcome

Cases With Revision of the Femoral Cone Augment or Tibial Cone Augment for Aseptic Loosening.
Time frame: 2 year
The primary efficacy parameter is the revision/removal of femoral cone augment or tibial cone augment for aseptic loosening at 2 years postoperative. Success at 2 years is defined as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening within 2 years.

2 secondary outcomes

Location and Severity of End-of-stem Pain.
Time frame: 2 year
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Time frame: Intraoperative

Results and safety

Results posted to the registry on 1 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triathlon Tritanium Cone Augments	254	135

Primary outcome: Cases With Revision of the Femoral Cone Augment or Tibial Cone Augment for Aseptic Loosening.

Time frame: 2 year. Number. Unit: cases

Measure	Revision/Removal of Cone Augment n = 190
Value	0

Population analysed: 190 participants / 194 cases were evaluated at the 2-year postoperative follow-up timeframe to determine if the femoral and/or tibial cone augment had been revised or removed due to aseptic loosening.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operative Site Events	29 of 194 (14.9%)	43 of 194 (22.2%)	0 of 194
Non-Operative Site Events	11 of 190 (5.8%)	0 of 0	11 of 190

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 4
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Recruiting
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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. This study is not recruiting at the moment.

Alvin Ong, MD principal investigator

Rothman Institute

Michael Masini, MD principal investigator

Michigan Heart, St. Joseph Health System

Yogesh Mittal, MD principal investigator

The Orthopaedic Center

9 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 Cone Augments in people with Arthroplasty and Replacement, run by Stryker Orthopaedics at 9 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 8 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 1 Jun 2026). 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?

Cases With Revision of the Femoral Cone Augment or Tibial Cone Augment for Aseptic Loosening. (time frame: 2 year). 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 NCT02521103.

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 1 Jun 2026.