Cemented vs Cementless Persona Keel RCT

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patient is of legal age and skeletally mature. 2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent document. 3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol. 4. 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.

Exclusion Criteria:

1. Patient is unwilling to sign the Informed Consent. 2. Patient is currently participating in any other surgical intervention or pain management study. 3. 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) 4. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions. 5. 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. 6. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation. 7. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty. Study Device-Specific

Exclusion Criteria:

8. Previous history of infection in the affected joint and/or other local/systematic infection that may affect the prosthetic joint. 9. Insufficient bone stock on femoral or tibial surfaces. 10. Neuropathic arthropathy. 11. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb. 12. A stable, painless arthrodesis in a satisfactory functional position. 13. Severe instability secondary to the absence of collateral ligament integrity. 14. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin. 15. The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05630053
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zimmer Biomet
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Polyarthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee

Additional Details

This is a prospective, multi-center, randomized controlled trial to demonstrate safety, performance, and clinical benefits of the Persona Keel CR Knee System and instrumentation. Participants that meet eligibility criteria and sign an institutional review board (IRB) Informed Consent form will be randomized to receive either the Persona OsseoTi Keel Cementless System or the Persona Keel Cemented System. Participants will be blinded to which arm they have been randomized to until after surgery. All study participants will undergo preoperative clinical evaluations prior to their total knee arthroplasty. Investigators will collect clinical data for up to 5 years; follow-up clinic visits will occur at 3 months, 1 year, 2 years, and 5 years after surgery. A maximum of 10 sites will contribute to this study. There will be a maximum of 300 participants enrolled (150 Cementless, 150 Cemented).

Arms & Interventions

Arms

Active Comparator: Cementless Persona Keel Knee System

Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia

Active Comparator: Cemented Persona Keel Knee System

Persona Keel Cemented Tibia

Interventions

Device: - Cementless Persona Knee System

The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.

Device: - Cemented Persona Knee System

The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Centura Health, Westminster, Colorado

Status

Recruiting

Address

Centura Health

Westminster, Colorado, 80023

Site Contact

Hannah Audet

[email protected]

574-527-3850

Baptist Health South Florida, Coral Gables, Florida

Status