Arthroplasty, Replacement, KneePKRNCT00966979

Triathlon® Partial Knee Replacement (PKR) Outcomes Study

A study testing Triathlon PKR in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 9 sites in 4 countries.

Terminated

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

Official record

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Trial summary

The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Arthroplasty, Replacement, Knee
What is being tested?: Triathlon PKR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 111 participants
Where: 9 sitesin 4 countries
Study dates: Jan 2010to May 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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
The subject requires a primary cemented unicompartmental knee replacement.
The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus.
The subject has signed the Institutional Review Board (IRB) approved study specific Informed Patient Consent Form.
The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Who cannot join

The subject has inflammatory arthritis or avascular necrosis(AVN).
The subject is obese, BMI > 35.
The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
The subject has a history of anterior cruciate ligament (ACL) reconstruction.
The subject has had a high distal femoral, or proximal tibial osteotomy.
The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device.

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The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study.
The subject is immunologically suppressed, or is receiving chronic steroids (>30 days duration).
The subject has a known sensitivity to device materials.
The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis.
The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
The subject has an active or suspected latent infection in or about the knee joint.
The subject is a prisoner.

Trial locations and contacts

9 sites in 4 countries.

Country

City, postcode or hospital

9 sites in 4 countries

United States6 sites

Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
Buffalo, New York, 14203
Rothman Institute
Egg Harbor, New Jersey, 08234
Heekin Orthopaedic Institute for Research, Inc.
Jacksonville, Florida, 32204
Rothman Institute
Media, Pennsylvania, 19063
Mansfield Orthopaedics
Morrisville, Vermont, 05661
Syracuse Orthopedic Specialists
Syracuse, New York, 13214

Other trials in United States

Germany1 site

Praxisklinik Stollberg und Arthro. Zentrum GmbH
Stollberg, 09366

Other trials in Germany

Italy1 site

Presidlo Ospedaliero Civile Santi Antonio e Biagio
Alessandria, 15100

Other trials in Italy

Sweden1 site

Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan
Hässleholm

Other trials in Sweden

About this study

Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System

Conditions: Arthroplasty, Replacement, Knee
Being tested: Triathlon PKR
Keywords: Osteoarthritis, Post-traumatic arthritis
Medical subject headings: Osteoarthritis

What participants receive

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

Triathlon PKRDevice
Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.

Study groups in NCT00966979
Study group	Role	What they receive
Triathlon PKR	Other	All subjects enrolled will receive the Triathlon PKR device. Receives: Device: Triathlon PKR

What is being measured

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

Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS).
This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.
Measured: 10 years

Secondary outcomes (1)

10-years Kaplan Meier Survival Analysis
For the purpose of this study the Kaplan-Meier survival curves are a statistical method to estimate the survival function from lifetime data of a knee replacement after treatment. Survivorship is defined as a percentage of knees free of any component revision for any reason.
Measured: 10-years

Timeline

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

Jan 2010May 2023

First posted27 Aug 2009 (estimated)
Study startJan 2010
Primary completionSep 2022
Study completionMay 2023

Why it stopped: Enrollment goals not being met.

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00966979
Sponsor's protocol ID: 66
Acronym: PKR
Status last verified: Aug 2023
First submitted: 25 Aug 2009
Last updated: 13 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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, Replacement, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System
ClinicalTrials.gov ID: NCT00966979
Acronym / sponsor ID: PKR / 66
Conditions: Arthroplasty, Replacement, Knee
Keywords: Osteoarthritis, Post-traumatic arthritis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment goals not being met.
Enrolment: 111 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Jan 2010 (actual)
Primary completion: Sep 2022 (actual)
Study completion: May 2023 (actual)
First posted: 27 Aug 2009 (estimated)
Results: Posted 13 Sep 2023

Clinical summary

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

Study design

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

Arm	Type	Receives
Triathlon PKR	Other	Device: Triathlon PKRAll subjects enrolled will receive the Triathlon PKR device.

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
The subject requires a primary cemented unicompartmental knee replacement.
The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.

Key exclusion criteria (13 listed)

The subject has inflammatory arthritis or avascular necrosis(AVN).
The subject is obese, BMI > 35.
The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
The subject has a history of anterior cruciate ligament (ACL) reconstruction.
The subject has had a high distal femoral, or proximal tibial osteotomy.

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 PKRTriathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.	Device	Triathlon PKR

Primary outcome

Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
Time frame: 10 years
The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS). This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.

1 secondary outcome

10-years Kaplan Meier Survival Analysis
Time frame: 10-years

Results and safety

Results posted to the registry on 13 Sep 2023, 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 PKR Unicompartmental Knee	111	13

Primary outcome: Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).

Time frame: 10 years. Mean (Standard Deviation). Unit: units on a scale

Measure	Triathlon PKR Unicompartmental Knee n = 12
Value	98.33 (5.77)

Population analysed: Due to early study termination the primary outcome was only reached for a minimal number of participants (12) reaching 10 years. These only included prospective cases. No retrospective cases reached the 10-year time interval.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: This study required that all operative site adverse events, regardless of seriousness, and serious systemic events, be reported from enrollment to the 10-year postoperative time interval.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operative Adverse Events	11 of 89 (12.4%)	26 of 89 (29.2%)	0 of 89
Non-Operative Adverse Events	20 of 88 (22.7%)	0 of 88 (0%)	1 of 88

Limitations and caveats (from the sponsor): After 13-years the enrollment goal was not met. This led to a protocol amendment to include retrospective cases. These cases were combined with the initial prospective cases and followed prospectively for the planned observation time. This study does not compare prospective to retrospective cases. The retrospectively enrolled cases were followed prospectively and there were no retrospective cases that reached the 10-year time point, only 12 prospective cases had 10-year data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Knee

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The Effect of Mind Mapping-Based Education on Postoperative Pain, Kinesiophobia, and Discharge Readiness in Patients Undergoing Total Knee Arthroplasty
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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.

R. David Heekin, M.D. principal investigator

St. Vincent's Medical Center

Marco Tinius, MD principal investigator

Praxisklinik Stollberg

Marco Schiraldi, MD principal investigator

Presidlo Ospedaliero Civile Santi Antonio e Biagio

9 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Triathlon PKR in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 9 sites in 4 countries.

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 8 inclusion and 13 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 13 Sep 2023. 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, Germany, Italy, Sweden. 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 13 Sep 2023). 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?

Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS). (time frame: 10 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 NCT00966979.

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 13 Sep 2023.