Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Zimmer Biomet

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

Research Team

Hillary Overholser

Principal Investigator

Zimmer Biomet

Eligibility Criteria

Inclusion Criteria

Patient is of legal age and skeletally mature

Patient is willing and able to provide written Informed Consent by signing and dating the Institutional Review Board (IRB) / Ethics Committee (EC) approved Informed Consent document

Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol

Treatment Details

Interventions

• Total Knee Arthroplasty (Procedure)

Participant Groups

Group I: Cohort 9 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Group II: Cohort 8 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group III: Cohort 7 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group IV: Cohort 6 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group V: Cohort 5 Experimental Treatment 1 Intervention

Cementless Femur Cemented Tibia

Group VI: Cohort 4 Experimental Treatment 1 Intervention

Cemented Femur Cemented Tibia

Group VII: Cohort 3 Experimental Treatment 1 Intervention

Cemented Femur Cemented Tibia

Group VIII: Cohort 2 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Group IX: Cohort 12 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia Cementless Patella

Group X: Cohort 11 Experimental Treatment 1 Intervention

Intended to capture on-label configurations of newly cleared components not captured in cohorts 1-10.

Group XI: Cohort 10 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Group XII: Cohort 1 Experimental Treatment 1 Intervention

Cementless Femur Cementless Tibia

Total Knee Arthroplasty is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Total Knee Arthroplasty for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in Japan as Total Knee Replacement for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in China as Total Knee Arthroplasty for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Approved in Switzerland as Total Knee Replacement for:

• Severe knee pain and disability due to degenerative joint disease, rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and avascular necrosis of the femoral condyle

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Foundation for Orthopaedic Research & Education Tampa, FL

UVA Health Orthopedic Center Charlottesville, VA

University of Michigan Ann Arbor, MI

Mayo Clinic Rochester, MN

More Trial Locations

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Patients Recruited

67,800+