Clinical trial NCT05630053: Cemented vs Cementless Persona Keel RCT
Official title: Randomized Controlled Trial to Compare Persona OsseoTi Keel Cementless TKA vs Persona Keel Cemented TKA
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Pain Chronic
Rheumatoid Arthritis
Osteoarthritis
Traumatic Arthritis
Polyarthritis
Avascular Necrosis
Varus Deformity
Valgus Deformity
Flexion Deformity of Knee
Keywords: Total Knee Replacement
Total Knee Arthroplasty
Osteoarthritis
Rheumatoid Arthritis
Cementless
Cementless Knee
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Oxford Knee Score (OKS)
timeFrame: 5 years
Secondary outcomes:
measure: Survival Rate of Implant
timeFrame: 5 years
measure: Frequency and types of Adverse Events
timeFrame: 5 years
measure: EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire
timeFrame: 5 years
measure: Numeric Rating Scale (Pain)
timeFrame: 5 years
measure: Patient Expectations Pre- and Post-op
timeFrame: 5 years
measure: Rate of Radiolucencies
timeFrame: 5 years
Other outcomes:
measure: Operative Room Time
timeFrame: During surgery
Locations:
city: Westminster
country: United States
facility: Centura Health
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bryn Mawr
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Dickson City
country: United States
facility: Lehigh Valley Hospital - Dickson City
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Alexandria
country: United States
facility: Anderson Orthopaedic Research Institute
state: Virginia
Study officials:
References: