Triathlon All-Polyethylene Tibia Outcomes Study

Study Purpose

The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusions:

  • - Patient underwent primary TKA and is currently implanted with the Triathlon All- Polyethylene Tibia as well as compatible Stryker femoral and patellar components with no pending revision or removal.
  • - Patient has signed an IRB-approved, study specific Informed Patient Consent Form.
  • - Patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation.
  • - Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Exclusions:
  • - Patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
  • - Patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation.
  • - Patient was skeletally immature at time of study device implantation.
  • - Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  • - Patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
  • - Patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
  • - Patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. > 30 days).
  • - Patient is a prisoner.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04636190
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Stryker Orthopaedics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthropathy of Knee, Replacement, Knee Arthritis
Additional Details

After being informed about the study, all patients giving written consent will undergo a screening period to determine eligibility for the study. If eligibility is met, data will be obtained retrospectively from the medical records from the preoperative to shortly after surgery time period. Thereafter, the subject will be evaluated at their 5-year and 10-year post surgery anniversary date.

Arms & Interventions

Arms

Other: Triathlon All-Polyethylene Tibia Knee

All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.

Interventions

Device: - Triathlon All-Polyethylene Tibia Knee

Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Michigan Orthopaedic Center, Lansing, Michigan

Status

Recruiting

Address

Michigan Orthopaedic Center

Lansing, Michigan, 48910

Buffalo, New York

Status

Recruiting

Address

Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital

Buffalo, New York, 14203

Duke University Medical Center, Durham, North Carolina

Status

Terminated

Address

Duke University Medical Center

Durham, North Carolina, 27703

Cleveland, Ohio

Status

Recruiting

Address

Department of Orthopaedic Surgery Cleveland Clinic

Cleveland, Ohio, 44195

Austin, Texas

Status

Recruiting

Address

Musculoskeletal Institute, University of Texas Health Austin

Austin, Texas, 78712