Cemented vs Cementless Persona Keel RCT

Description

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

Conditions

Knee Pain Chronic, Rheumatoid Arthritis, Osteoarthritis, Traumatic Arthritis, Polyarthritis, Avascular Necrosis, Varus Deformity, Valgus Deformity, Flexion Deformity of Knee

Study Overview

Study Details

Study overview

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

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

Cemented vs Cementless Persona Keel RCT

Condition
Knee Pain Chronic
Intervention / Treatment

-

Contacts and Locations

Westminster

Centura Health, Westminster, Colorado, United States, 80023

Coral Gables

Baptist Health South Florida, Coral Gables, Florida, United States, 33146

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21224

Bryn Mawr

Rothman Institute, Bryn Mawr, Pennsylvania, United States, 19010

Dickson City

Lehigh Valley Hospital - Dickson City, Dickson City, Pennsylvania, United States, 18519

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Alexandria

Anderson Orthopaedic Research Institute, Alexandria, Virginia, United States, 22306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zimmer Biomet,

Study Record Dates

2032-12