Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet

About 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

Eligibility criteria

Qualifiers

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

Independent of study participation, patient qualifies for either cemented or cementless primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling

Disqualifiers

Patient is currently participating in any other surgical intervention or pain management study

Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)

Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions

Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study

Trial design

Treatments tested in this trial

  • Total Knee Arthroplasty

Treatment groups

760 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Sponsors and collaborators