Cemented vs Cementless Persona Keel RCT
Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA
1 other identifier
interventional
300
1 country
7
Brief Summary
The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedStudy Start
First participant enrolled
July 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
April 27, 2026
April 1, 2026
8.8 years
October 18, 2022
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxford Knee Score (OKS)
A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations. The primary endpoint is based on the change in OKS scores from baseline to 2-year postoperative follow-up as well as from baseline to 5-year postoperative follow-up.
5 years
Secondary Outcomes (6)
Survival Rate of Implant
5 years
Frequency and types of Adverse Events
5 years
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire
5 years
Numeric Rating Scale (Pain)
5 years
Patient Expectations Pre- and Post-op
5 years
- +1 more secondary outcomes
Other Outcomes (1)
Operative Room Time
During surgery
Study Arms (2)
Cementless Persona Keel Knee System
ACTIVE COMPARATORPersona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia
Cemented Persona Keel Knee System
ACTIVE COMPARATORPersona Keel Cemented Tibia
Interventions
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient is unwilling to sign the Informed Consent
- Patient is currently participating in any other surgical intervention or pain management study
- 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
- Insufficient bone stock on femoral or tibial surfaces.
- Neuropathic arthropathy
- Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb
- A stable, painless arthrodesis in a satisfactory functional position
- Severe instability secondary to the absence of collateral ligament integrity
- Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- The kinematic alignment surgical technique is contraindicated for patients with greater than 5° valgus deformity with MCL insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (7)
Centura Health
Westminster, Colorado, 80023, United States
Northwestern University
Chicago, Illinois, 60611, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Oregon Health & Science University
Portland, Oregon, 972329, United States
Rothman Institute
Bryn Mawr, Pennsylvania, 19010, United States
Lehigh Valley Hospital - Dickson City
Dickson City, Pennsylvania, 18519, United States
Anderson Orthopaedic Research Institute
Alexandria, Virginia, 22306, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants should be masked until after the surgical procedure.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2022
First Posted
November 29, 2022
Study Start
July 25, 2023
Primary Completion (Estimated)
May 1, 2032
Study Completion (Estimated)
December 1, 2032
Last Updated
April 27, 2026
Record last verified: 2026-04