Persona Partial Knee Clinical Outcomes Study

Osteoarthritis Clinical Trial

Official title:

Persona Partial Knee Clinical Outcomes Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03034811
• Other study ID #: K.CR.I.G.16.16
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 8, 2017
• Est. completion date: July 2029

Study information

• Verified date: August 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.

Description:

The study design is a prospective, multicenter, noncontrolled study of the commercially available Persona Partial Knee. The study will require each site to obtain 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 partial knee arthroplasty. Investigators will collect clinical data for a required 2 years with the option to continue follow-up assessment up to 10 years. Follow-up clinical visits include 3 months, 1 year, 2, 5, and 10 years post-operatively.

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System. The assessments will include: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical performance measured by overall pain and function, quality of life data, radiographic parameters, and survivorship.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 643
• Est. completion date: July 2029
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is at least 18 years of age

• Patient qualifies for knee arthroplasty based upon physical exam and medical history, and meets the approved indications for use of the Persona Partial Knee system.

• Patient has participated in a study-related Informed Consent process

• Patient is willing and able to provide written Informed Consent by signing and dating the IRB/EC approved Informed Consent form

• Patient is willing and able to complete scheduled study procedures and follow-up evaluations

• Independent of study participation, patient is a candidate for the commercially available Persona Partial Knee, implanted in accordance with product labeling

Exclusion Criteria:

• Patient is currently participating in any other surgical intervention studies or pain management studies

• Infection, sepsis, and osteomyelitis

• Rheumatoid arthritis or other forms of inflammatory joint disease

• Insufficiency of the collateral, anterior or posterior cruciate ligaments which would preclude stability of the device

• Full thickness damage to the weight bearing area of the contralateral compartment

• Uncooperative patient or patient with neurologic disorders who is incapable of following directions

• Insufficient bone stock to provide adequate support and/or fixation to the prosthesis

• Metabolic disorders which may impair bone formation

• Osteomalacia

• Distant foci of infections which may spread to the implant site

• Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

• Vascular insufficiency, muscular atrophy, neuromuscular disease

• Incomplete or deficient soft tissue surrounding the knee

• Charcot's disease

• Fixed varus deformity (not passively correctable) of greater than 15 degrees

• Fixed flexion deformity (not passively correctable) of greater than 15 degrees

• Patient is pregnant or considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Related Conditions & MeSH terms

• Arthritis
• Avascular Necrosis
• Conditional Revision of the Articular Surface
• Conditional Tibial Condyle or Plateau Fractures
• Necrosis
• Osteoarthritis
• Traumatic Arthritis

Intervention

Device:
• Persona Partial Knee system
Fixed bearing partial knee

Locations

Country	Name	City	State
Austria	Orthopädisches Spital Speising	Vienna
Belgium	Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert
France	Marseille University-Hospital Centres	Marseille
France	Public Hospital of Versailles	Versailles
Germany	Hessing Stiftung	Augsburg
Germany	Sana Kliniken Sommerfeld	Berlin
Germany	Waldkrankenhaus Eisenberg	Eisenberg
Italy	Orthopedic Institute IRCCS	Milan
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Spain	Hospital Alcorcón	Madrid
Sweden	Umea University Hospital	Umea
Switzerland	Hopital d'Yverdon les Bains	Yverdon les Bains
United Kingdom	Avon Orthopaedic Centre, Southmead Hospital	Bristol
United Kingdom	Royal Derby Hospital	Derby
United Kingdom	Harrogate and District NHS Foundation Trust	Harrogate
United States	New Mexico Orthopaedics	Albuquerque	New Mexico
United States	Sports Medicine North	Beverly	Massachusetts
United States	Midwest Orthopaedics at Rush	Chicago	Illinois
United States	Midlands Orthopaedics & Neurosurgery	Columbia	South Carolina
United States	Sah Orthopaedic Associates	Fremont	California
United States	Panorama Orthopedics & Spine Center	Golden	Colorado
United States	Skagit Regional Clinics-Riverbend	Mount Vernon	Washington
United States	Henry County Orthopedics and Sports Medicine	New Castle	Indiana
United States	Troy Orthopaedic Associates	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  France,  Germany,  Italy,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxford Knee Score	A Patient reported functional outcome score for knee arthroplasty	10 years
Secondary	EQ-5D	a questionnaire completed by the Patient and assesses his/her General health Status. The EQ5D is used to derive a Quality of life index used for health economics considerations.	10 years