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Cemented vs Cementless Persona Keel RCT

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ClinicalTrials.gov Identifier: NCT05630053
Recruitment Status : Recruiting
First Posted : November 29, 2022
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Pain Chronic Rheumatoid Arthritis Osteoarthritis Traumatic Arthritis Polyarthritis Avascular Necrosis Varus Deformity Valgus Deformity Flexion Deformity of Knee Device: Cementless Persona Knee System Device: Cemented Persona Knee System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants should be masked until after the surgical procedure.
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA
Actual Study Start Date : July 25, 2023
Estimated Primary Completion Date : May 2032
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Oxford Knee Score (OKS) [ Time Frame: 5 years ]
    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.


Secondary Outcome Measures :
  1. Survival Rate of Implant [ Time Frame: 5 years ]
    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.

  2. Frequency and types of Adverse Events [ Time Frame: 5 years ]
    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.

  3. EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire [ Time Frame: 5 years ]

    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).


  4. Numeric Rating Scale (Pain) [ Time Frame: 5 years ]
    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. Patient Expectations Pre- and Post-op [ Time Frame: 5 years ]

    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


  6. Rate of Radiolucencies [ Time Frame: 5 years ]
    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.


Other Outcome Measures:
  1. Operative Room Time [ Time Frame: During surgery ]
    Evaluation of differences in operative times between implantation of cemented and cementless systems.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05630053


Contacts
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Contact: Brittany Nierste 574-527-3850 brittany.nierste@zimmerbiomet.com
Contact: Branden Kemp 574-286-3043 branden.kemp1@zimmerbiomet.com

Locations
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United States, Colorado
Centura Health Recruiting
Westminster, Colorado, United States, 80023
Contact: Hannah Audet       hannahaudet@centura.org   
Principal Investigator: Ian Weber, M.D.         
United States, Florida
Baptist Health South Florida Withdrawn
Coral Gables, Florida, United States, 33146
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Megan VanDyke       megan.vandyke@nm.org   
Principal Investigator: Linda Suleiman, M.D.         
Principal Investigator: Adam Edelstein, M.D.         
United States, Pennsylvania
Rothman Institute Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Brooke Olin       Brooke.olin@rothmanortho.com   
Principal Investigator: Jess Lonner, M.D.         
Sub-Investigator: Yale Fillingham, M.D.         
Sub-Investigator: Maxwell Courtney, M.D.         
Lehigh Valley Hospital - Dickson City Recruiting
Dickson City, Pennsylvania, United States, 18519
Contact: Christina Gogal       Christina_C.Gogal@lvhn.org   
Principal Investigator: Harry Schmaltz, M.D.         
United States, Texas
Houston Methodist Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Thomas Sullivan       tsullivan@houstonmethodist.org   
Principal Investigator: Timothy Brown, M.D.         
Sub-Investigator: Kwan Park, M.D.         
United States, Virginia
Anderson Orthopaedic Research Institute Recruiting
Alexandria, Virginia, United States, 22306
Contact: Nancy Parks       nparks@aori.org   
Principal Investigator: Robert Sershon, M.D.         
Sponsors and Collaborators
Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT05630053    
Other Study ID Numbers: CMG2022-08K
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024

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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
Keywords provided by Zimmer Biomet:
Total Knee Replacement
Total Knee Arthroplasty
Osteoarthritis
 Rheumatoid Arthritis
Cementless
Cementless Knee
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Congenital Abnormalities
Necrosis
Joint Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes