Zimmer POLAR - Total Knee Arthroplasty (TKA)

Completed · Not applicable

Conditions studied: Osteoarthritis, RheumatoId Arthritis, Traumatic Arthritis, Polyarthritis

In brief

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Persona fixed bearing knee implants used in total knee arthroplasty. The assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.

Key facts

Study ID

NCT01859130

Run by

Zimmer Biomet

People needed

299

Starts

2013-10-21

Expected to finish

2021-12-31

Last updated by the study team

2023-10-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient 18-75 years of age, inclusive;
• Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to at least one of the following:
• rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis;
• collagen disorders and/or avascular necrosis of the femoral condyle;
• post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• moderate valgus, varus, or flexion deformities;
• the salvage of previously failed surgical attempts that did not include partial or total knee arthroplasty of the ipsilateral knee;
• Patient has participated in a study-related Informed Consent process;
• Patient is willing and able to complete scheduled study procedures and follow-up evaluations;
• Independent of study participation, patient is a candidate for commercially available Persona fixed bearing knee components implanted in accordance with product labeling.

You may not qualify if…

• Patient is currently participating in any other surgical intervention studies or pain management studies;
• Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint;
• Insufficient bone stock on femoral or tibial surfaces;
• Skeletal immaturity;
• Neuropathic arthropathy;
• Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
• Stable, painless arthrodesis in a satisfactory functional position;
• Severe instability secondary to the absence of collateral ligament integrity;
• Rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin;
• Patient has a known or suspected sensitivity or allergy to one or more of the implant materials;
• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.);
• Patient has previously received partial or total knee arthroplasty for the ipsilateral knee.

Where it is running

• Midwest Orthopaedics at Rush — Naperville, Illinois, United States
• The Rothman Institute — Egg Harbor, New Jersey, United States
• Duke University — Durham, North Carolina, United States
• The Rothman Institute — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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