Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

Rheumatoid Arthritis Clinical Trial

Official title:

Persona® OsseoTi® Keel Compatibility Study-A Multicenter Cohort Study A Prospective, Post-market Clinical Follow-up Study to Demonstrate Safety, Performance and Clinical Benefits of the Persona Knee System Portfolio and Its Instrumentation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787821
• Other study ID #: CMU2022-39K
• Status: Recruiting
• Start date: June 28, 2023
• Est. completion date: June 2031

Study information

• Verified date: June 2024
• Source: Zimmer Biomet
• Contact: Tim Swanson
• Phone: 5745497606
• Email: tim.swanson[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

Description:

The study design is a prospective, multicenter data collection model of the 510(k) cleared Persona Total Knee System. The study will require each site to obtain institutional review board (IRB) approval prior to study enrollment. All potential study subjects will be required to participate in the Informed Consent Process.

All study subjects will undergo preoperative clinical evaluations prior to their total knee arthroplasty (TKA). Investigators will collect clinical data for a required 5 years. Follow-up clinical visits include 3 months, 1, 2, and 5 years post-operatively.

Specific assessments include:

1. Confirming the safety, performance and clinical benefits of the Persona total knee system and instrumentation in primary and revision TKA.

2. Verifying that, under normal use, the performance and clinical benefits of this device and its instrumentation conform to those intended by the manufacturer by recording patient-reported clinical outcomes measures (PROMs) and radiographic outcomes (if available).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: June 2031
• Est. primary completion date: June 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Institutional Review Board (IRB) / Ethics Committee (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 primary or revision total knee arthroplasty (including salvage of previously failed surgical attempts) based upon physical exam and medical history, and meets the approved indications for use of the commercially available Persona Knee System with appropriately matched Zimmer Biomet components implanted in accordance with product labeling

Exclusion Criteria:

1. Patient is currently participating in any other surgical intervention or pain management study

2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)

3. Patient has a mental or neurological condition who is unwilling or incapable of following postoperative care instructions

4. Patient has a condition which would, in the judgment of the investigator, place the patient at undue risk or interfere with the conduct of the study

5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation

6. Patient is scheduled to undergo simultaneous bilateral total knee arthroplasty

7. Previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint

8. Insufficient bone stock on femoral or tibial surfaces

9. Neuropathic arthropathy

10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb

11. A stable, painless arthrodesis in a satisfactory functional position

12. Severe instability secondary to the absence of collateral ligament integrity

13. Rheumatoid Arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin

14. Patient has a > 5° valgus deformity with a medial collateral ligament (MCL) insufficiency, and the surgeon intends to use the personalized alignment surgical technique

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Congenital Abnormalities
• Knee Pain Chronic
• Necrosis
• Osteoarthritis
• Osteoarthritis, Knee
• Polyarthritis
• Rheumatoid Arthritis
• Traumatic Arthritis
• Valgus Deformity
• Varus Deformity

Locations

Country	Name	City	State
United States	New Mexico Orthopaedic Associates	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Northside Hospital, Inc.	Atlanta	Georgia
United States	OrthoCarolina Research Institute, Inc.	Charlotte	North Carolina
United States	UVA Health Orthopedic Center	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Syracuse Orthopaedic Specialists	DeWitt	New York
United States	UT Health at Houston	Houston	Texas
United States	Mississippi Sports Medicine and Orthopaedic Center	Jackson	Mississippi
United States	U of L Health	Louisville	Kentucky
United States	Duke University	Morrisville	North Carolina
United States	Southern Joint Replacement Institute	Nashville	Tennessee
United States	NYU	New York	New York
United States	Denver Hip & Knee, Inc.	Parker	Colorado
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Francis Hospital & Heart Center	Roslyn	New York
United States	Foundation for Orthopaedic Research & Education	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Knee Score (OKS)	A patient reported functional outcome score for knee arthroplasty. This score ranges from 0-48, with higher scores indicating a better outcome.	5 years
Secondary	EuroQol Five Dimension Five Level (EQ-5D-5L) Outcomes Measure	A questionnaire completed by the patient and assesses his/her general health status. This score ranges from -0.573 to 1, with higher recorded scores indicating better overall health.	5 years
Secondary	Pain and Satisfaction Numeric Rating Scale (NRS)	Patients will rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain"). Along with their pain rating, subjects will be asked to rate their current satisfaction with their surgery from "Very Dissatisfied" to "Very Satisfied".	5 years