Arthroplasty, Replacement, KneeNCT00958789

Triathlon Total Stabilizer (TS) Outcomes Study

A study testing Triathlon TS Knee System in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Knee
What is being tested?: Triathlon TS Knee System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 12 sitesUnited States
Study dates: Jul 2009to 28 Mar 2019
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) approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female 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) > 40.
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

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Tufts Medical Center
Boston, Massachusetts, 02111
University of North Carolina Orthopedics
Chapel Hill, North Carolina, 27599
Midwest Orthopaedics at Rush
Chicago, Illinois, 60612
Wellington Orthopaedic & Sports Medicine
Cincinnati, Ohio, 45255
Duke University Medical Center
Durham, North Carolina, 27703
Upstate Bone and Joint Center
East Syracuse, New York, 13057
Rothman Institute
Egg Harbor, New Jersey, 08234
Heekin Institute for Orthopedic Research
Jacksonville, Florida, 32204
The CORE Institute
Phoenix, Arizona, 85023
Ridgewood Orthopedics
Ridgewood, New Jersey, 07450
Scott & White Clinic
Temple, Texas, 76508
The Orthopaedic Center
Tulsa, Oklahoma, 74120

Other trials in United States

About this study

Official title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Total Stabilizer (TS) Total Knee System

This study will be a prospective, non-randomized evaluation of the change between preoperative and postoperative outcomes for those receiving the Triathlon® TS Total Knee System for a revision knee operation. The mean total Knee Society Score (for pain, motion and function) change is not 10% worse than, or is superior to, the expected change according to published revision total knee replacement data, for cases implanted with the Triathlon® TS Total Knee System as compared from preoperative to 2 years postoperative.

Conditions: Arthroplasty, Replacement, Knee
Being tested: Triathlon TS Knee System

What participants receive

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

Triathlon TS Knee SystemDevice
Total knee replacement for revision cases

Study groups in NCT00958789
Study group	Role	What they receive
Triathlon TS Knee	Other	Triathlon TS Knee System Receives: Device: Triathlon TS Knee System

What is being measured

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

Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
KSS Pain score, KSS Function score, Total Combined KSS
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).
Measured: pre-op, 2 years

Secondary outcomes (10)

Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
This outcome measure shows the results of the KSS Functional Score for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm.
The Functional Score of the Knee Society Clinical Rating System ranges from a potential minimum score of 0 to a maximum score of 100 points. It is based on points assigned to ability to walk, climb stairs and the use of ambulatory aids. A higher value represents a better outcome.
Measured: 2 years, 5 years
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Measures the knee stability results for the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by amount in mm that the joint line was restored to physiological joint line postoperative. One group were restored to ≤ 5 mm and the other were restored to > 5mm. Knee stability is evaluated in the anterior-posterior (AP) and medial-lateral (ML) planes.
AP drawer test determines instability in mm of the tibia. It was done in the AP plane in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years. The AP measurements were sub categorized into 5mm and 5-10mm.
ML is tested with a varus valgus stress test to determine any instability as measured in degrees. The ML measurements were done in both JLR groupings (≤ 5mm and > 5mm) at 2 years and 5 years with all results in only one category of < 5 degrees.
The higher the number of degrees or mm measured the more instability in the knee.
Measured: 2 year and 5 year postoperative
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Measures the presence or absence of anterior knee pain in the groupings of the Joint Line Restoration (JLR). The 2 groups of JLR were stratified by the amount in mm that the joint line was restored to the physiological joint line postoperative. One group was those that were restored to ≤ 5 mm and the other was those that were restored to > 5mm.
Anterior knee pain is determined by clinical examination with patient and clinician whether it is present or absent.
Measured: 2 year and 5 year postoperative
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
The SF-36 Health Survey is a 36-item patient completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Measured: pre-op, 1, 2, 5 years
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
The scoring system was based on the Knee Society guidelines and determined by measuring the width of the radiolucent lines for each of the zones of the implant components in millimeters.
The total widths are added for each zone which produces a numerical score. Radiolucency in at least 50% of a zone and measuring at least 1 mm in width is defined as radiolucency present. Failure is defined as a score of 10 or greater, regardless of symptoms and considered as radiographic instability.
Measured: 1, 2, 5 years
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Revision was defined as the removal of either the femoral component or the tibial baseplate component.
Measured: 5 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: pre-op, 1, 2, 5 years
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
The HSS Patella Score incorporates both subjective symptoms and objective data specific to the patellofemoral joint. It consists of one score from 0-100 with a score of 100 indicating no pain, no functional limitations, no tenderness or crepitus and normal quadriceps strength.
Measured: pre-op, 1, 2, 5 years
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Measured: pre-op, 1, 2, 5 years
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, ROM and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Measured: pre-op, 1,2, 5 year

Timeline

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

Jul 200928 Mar 2019

First posted13 Aug 2009 (estimated)
Study startJul 2009
Primary completion25 Apr 2016
Study completion28 Mar 2019

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: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00958789
Sponsor's protocol ID: 65
Status last verified: Oct 2021
First submitted: 11 Aug 2009
Last updated: 22 Oct 2021
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 22 Oct 2021. 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® Total Stabilizer (TS) Total Knee System
ClinicalTrials.gov ID: NCT00958789
Acronym / sponsor ID: 65
Conditions: Arthroplasty, Replacement, Knee
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Stryker OrthopaedicsIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: 25 Apr 2016 (actual)
Study completion: 28 Mar 2019 (actual)
First posted: 13 Aug 2009 (estimated)
Results: Posted 19 May 2017

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 TS Knee	Other	Device: Triathlon TS Knee SystemTriathlon TS Knee System

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) approved, study specific Informed Patient Consent Form.
Patient is a male or non-pregnant female 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) > 40.
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 TS Knee SystemTotal knee replacement for revision cases	Device	Triathlon TS Knee

Primary outcome

Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years
Time frame: pre-op, 2 years
KSS Pain score, KSS Function score, Total Combined KSS The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome. Additionally, the KSS Pain subscore and KSS Function subscore are added together to obtain a total combined score (minimum score 0, maximum score 200).

10 secondary outcomes

Knee Society Score (KSS) Functional Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Time frame: 2 years, 5 years
Knee Stability Results Stratified by Joint Line Restoration Groups at 2 and 5 Year Postoperative
Time frame: 2 year and 5 year postoperative
Anterior Knee Pain Results Stratified by Joint Line Restoration Groups at 2 and 5 Years Postoperative
Time frame: 2 year and 5 year postoperative
Short Form Health Survey (SF-36) Health Survey Change From Pre-op to Post-op Visits
Time frame: pre-op, 1, 2, 5 years
Number of Knees With Radiographic Stability at 1, 2 and 5 Years Postoperative
Time frame: 1, 2, 5 years
Number of Knees With a Revision of Femoral and/or Tibial Baseplate Component
Time frame: 5 years
Knee Injury and Osteoarthritis Outcome Score (KOOS) Change From Pre-op to Post-op Visits
Time frame: pre-op, 1, 2, 5 years
Hospital Special Surgery (HSS) Patella Score Change From Pre-op to Post-op Visits
Time frame: pre-op, 1, 2, 5 years
Lower Extremity Activity Scale (LEAS) Score Change From Pre-op to Post-op Visits
Time frame: pre-op, 1, 2, 5 years
Knee Society Score (KSS) Change From Pre-op to Post-op Visits
Time frame: pre-op, 1,2, 5 year

Results and safety

Results posted to the registry on 19 May 2017, 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 TS Knee	180	130

Primary outcome: Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years

Time frame: pre-op, 2 years. Mean (Standard Deviation). Unit: units on a scale

Measure	Triathlon TS Knee n = 177
KSS Pain/motion score preoperative	39.81 (21.12)
KSS Pain/motion score 2 yrs.	83.97 (15.95)
KSS Function score preoperative	41.43 (23.09)
KSS Function score 2 yrs.	72.90 (25.12)
Combined KSS score preoperative	82.96 (34.96)
Combined KSS score 2 yrs.	157.05 (36.13)

Triathlon TS Knee: Mean Difference (Final Values): 70.70

Population analysed: KSS Function Score at 2 years - One case had a calculable score for Function and not for Pain/Motion. Therefore, the case was not included in the Combined KSS Score and Participant Flow completed total of 130.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: This study requires that all operative site adverse events, regardless of seriousness, and serious systemic adverse events be reported from enrollment through the 5 year postoperative interval. Censored protocol deviations were not included as at risk participants.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operative Adverse Events	37 of 181 (20.4%)	59 of 181 (32.6%)	0 of 181
Non-Operative Adverse Events	40 of 180 (22.2%)	0 of 180 (0%)	7 of 180

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Arthroplasty, Replacement, Knee

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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.

Kirby D Hitt, M.D. study chair

Scott & White Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing Triathlon TS Knee System in people with Arthroplasty, Replacement, Knee, run by Stryker Orthopaedics at 12 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: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 19 May 2017). 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?

Knee Society Score (KSS) Change From Preoperative Time Point to 2 Years (time frame: pre-op, 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 NCT00958789.

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 22 Oct 2021.