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NCT05630053 | RECRUITING | Knee Pain Chronic

Cemented vs Cementless Persona Keel RCT
Sponsor:

Zimmer Biomet

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

Knee Pain Chronic

Rheumatoid Arthritis

Osteoarthritis

Traumatic Arthritis

Polyarthritis

Avascular Necrosis

Varus Deformity

Valgus Deformity

Flexion Deformity of Knee

Intervention/treatment

Cementless Persona Knee System

Cemented Persona Knee System

Phase

NA

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
Estimated Enrollment : 300 participants
Masking : SINGLE
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 : 2023-07-25
Estimated Primary Completion Date : 2032-05
Estimated Study Completion Date : 2032-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Cemented vs Cementless Persona Keel RCT

Location Details

NCT05630053

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Health belt

Westminster, Colorado, United States, 80023

WITHDRAWN

United States, Florida

Baptist Health South Florida

Coral Gables, Florida, United States, 33146

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Pennsylvania

Rothman Institute

Bryn Mawr, Pennsylvania, United States, 19010

RECRUITING

United States, Pennsylvania

Lehigh Valley Hospital - Dickson City

Dickson City, Pennsylvania, United States, 18519

RECRUITING

United States, Texas

Houston Methodist Hospital

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

Anderson Orthopaedic Research Institute

Alexandria, Virginia, United States, 22306