Triathlon® Partial Knee Replacement (PKR) Outcomes Study

Study Purpose

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.

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	21 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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 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.	NCT00966979
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.	R. David Heekin, M.D.Marco Tinius, MDMarco Schiraldi, MDBrian Aros, MDFabio Orozco, MDMatthew Phillips, MDPeter Bonutti, MDSoren Toksvig-Larsen, MDBrett Greenky, MDPaul Jacob, MD
Principal Investigator Affiliation	St. Vincent's Medical CenterPraxisklinik StollbergPresidlo Ospedaliero Civile Santi Antonio e BiagioMansfield OrthopaedicsRothman InstituteDepartment of Orthopaedic Surgery, Kaleida Health, Buffalo General HospitalBonutti ClinicHassleholm Sygehus Ortopaedkirurgisk afd.Syracuse Orthopedic SpecialistsOklahoma Sports Science and Orthopaedics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany, Italy, Sweden, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Arthroplasty, Replacement, Knee

Arms & Interventions

Arms

Other: Triathlon PKR

All subjects enrolled will receive the Triathlon PKR device.

Interventions

Device: - Triathlon PKR

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

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.

Jacksonville, Florida

Status

Terminated

Address

Heekin Orthopaedic Institute for Research, Inc.

Jacksonville, Florida, 32204

Site Contact

[email protected]

201-831-5491

Bonutti Clinic, Effingham, Illinois

Status

Withdrawn