Cemented vs Cementless Persona Keel RCT

Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA

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

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Traumatic Arthritis; Varus Deformity; Valgus Deformity; Knee Pain Chronic; Polyarthritis; Flexion Deformity of Knee
• Intervention / Treatment: Device: Cementless Persona Knee System; Device: Cemented Persona Knee System

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Westminster, Colorado, United States, 80023
      • Centura Health
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Oregon
    • Portland, Oregon, United States, 972329
      • Oregon Health & Science University
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Rothman Institute
    • Dickson City, Pennsylvania, United States, 18519
      • Lehigh Valley Hospital - Dickson City
  • Virginia
    • Alexandria, Virginia, United States, 22306
      • Anderson Orthopaedic Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cementless Persona Keel Knee System; Persona PPS CoCr Cementless Femur and Persona OsseoTi Keel Cementless Tibia	Device: Cementless Persona Knee System; The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.; Other Names: Persona PPS CoCr Cementless Femur; Persona PPS Femur; PPS Femur; OsseoTi 0° Spiked Keel Tibia; OsseoTi Tibia; OsseoTi Spiked Keel Tibia; Spiked Keel Tibia; Cementless Tibia
Active Comparator: Cemented Persona Keel Knee System; Persona Keel Cemented Tibia	Device: Cemented Persona Knee System; The Persona Keel Knee system is a total knee system used in the replacement of the knee joint.; Other Names: Persona Keel Cemented Tibia; Keel Tibia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and types of Adverse Events	The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.	5 years
Numeric Rating Scale (Pain)	The 11-item pain NRS asks patients to rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). It is the most widely used instrument for pain screening with higher scores indicating greater pain intensity.	5 years
Rate of Radiolucencies	Radiographic parameters to be evaluated include, but are not limited to, radiolucencies, osteolysis, hypertrophy, subsidence, and heterotopic ossification. All radiographic evaluations performed according to the protocol will be reviewed by the investigator at the time of the evaluation for significant radiographic findings.	5 years
Survival Rate of Implant	Survival Rate (Survivorship) will be both assessed by revision/additional surgeries to the affected joint due to aseptic loosening only or by revision, removal, exchange of the implanted device due to any reason. Aseptic loosening and other reasons for additional surgeries may be identified by radiographic imaging.	5 years
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire	The EQ-5D-5L instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire produces an "index" score that ranges from 0 to 1, where 0 is the value of a health state equivalent to dead; and 1 is the value of full health, with higher scores indicating higher health utility. The EQ VAS is a 0 -100 scale where patients are asked to indicate their overall health on the day of questionnaire completion. 100 indicates the best health imaginable and 0 indicates the worst health imaginable. Change in Index and EQ VAS scores will be compared from baseline to 2-year follow-up as well as from baseline to 5-year postoperative follow-up for each cohort (cemented or cementless). This change will also be compared between the cohorts (delta from baseline to 2 years and baseline to 5 years in the cementless group compared to the same delta in the cemented group).	5 years
Patient Expectations Pre- and Post-op	Per the 2011 Knee Society scoring manual: "[This] is a three-question fifteen-point scale that is collected pre-operatively and post-operatively. The pre-operative questions reflect the patient's opinion on the extent to which the patient expects that the operation will improve their knee pain, and their ability to perform their activities of daily living and recreational activities. The post-operative questions reflect the extent to which the outcome after the operation has met the patient's pre-operative expectations with respect to pain and function." Higher scores preoperatively indicate more positive expectations of the patient's total knee replacement surgery, and higher scores postoperatively indicate	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Room Time	Evaluation of differences in operative times between implantation of cemented and cementless systems.	During surgery

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Osteoarthritis; Rheumatoid Arthritis; Total Knee Arthroplasty; Total Knee Replacement; Cementless; Cementless Knee
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Necrosis; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Osteonecrosis
• Other Study ID Numbers: CMG2022-08K

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes