ACTIVE_NOT_RECRUITING

Cemented vs Cementless Persona Keel RCT

Conditions

Knee Pain Chronic Rheumatoid Arthritis Osteoarthritis Traumatic Arthritis Polyarthritis Avascular Necrosis Varus Deformity Valgus Deformity Flexion Deformity of Knee Total Knee Replacement Total Knee Arthroplasty Cementless Cementless Knee

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-07-25

Study Completion:2032-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05630053

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Centura Health

Westminster, Colorado, 80023

United States

Northwestern University

Chicago, Illinois, 60611

United States

Johns Hopkins University

Baltimore, Maryland, 21224

United States

Oregon Health & Science University

Portland, Oregon, 972329

United States

Rothman Institute

Bryn Mawr, Pennsylvania, 19010

United States

Lehigh Valley Hospital - Dickson City

Dickson City, Pennsylvania, 18519

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Anderson Orthopaedic Research Institute

Alexandria, Virginia, 22306

United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-25

Study Completion Date2032-12

Study Record Updates

Study Start Date2023-07-25

Study Completion Date2032-12

Terms related to this study

Keywords Provided by Researchers

Total Knee Replacement
Total Knee Arthroplasty
Osteoarthritis
Rheumatoid Arthritis
Cementless
Cementless Knee

Additional Relevant MeSH Terms

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