Active — Not RecruitingNot Applicable

Cemented vs Cementless Persona Keel RCT

United States300 participantsStarted 2023-07-25

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient is of legal age and skeletally mature
✓. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/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 total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling.

✕. Patient is unwilling to sign the Informed Consent
✕. 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 would be inappropriate (e.g., prisoner; pediatric patients)
✕. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
✕. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
✕. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
✕. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
✕. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint

Oxford Knee Score (OKS)

Timeframe: 5 years

NCT IDNCT05630053

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2032-05

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patient is of legal age and skeletally mature
✓. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/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 total knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Keel Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling.

✕. Patient is unwilling to sign the Informed Consent
✕. 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 would be inappropriate (e.g., prisoner; pediatric patients)
✕. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions
✕. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study
✕. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation
✕. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty
✕. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint