Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05630053

Persona 0° Keel Randomized Controlled Trial

Conditions: Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Polyarthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 224
Sponsor: Zimmer Biomet

Summary

The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona 0° Keel cementless and cemented knee.

Eligibility Criteria

Inclusion Criteria:Patient is of legal age and skeletally maturePatient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent documentPatient is willing and able to complete scheduled follow-up evaluations as defined in the study protocolIndependent of study participation, patient qualifies for either cemented or cementless total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona 0°ׄ Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling.Exclusion Criteria:Patient is unwilling to sign the Informed ConsentPatient is currently participating in any other surgical intervention or pain management studyPatient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study would be inappropriate (e.g., prisoner; pediatric patients)Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructionsPatient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the studyPatient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participationPatient is scheduled to undergo simultaneous bilateral total knee arthroplastyStudy Device-Specific Exclusion Criteria:Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic jointInsufficient bone stock on femoral or tibial surfaces.Neuropathic arthropathyOsteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limbA stable, painless arthrodesis in a satisfactory functional positionSevere instability secondary to the absence of collateral ligament integrityRheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skinThe kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05630053). StuddyBuddy aggregates publicly available trial information.