Clinical trial NCT03034811: Persona Partial Knee Clinical Outcomes Study
Official title: Persona Partial Knee Clinical Outcomes Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Avascular Necrosis
Traumatic Arthritis
Conditional Tibial Condyle or Plateau Fractures
Conditional Revision of the Articular Surface
Keywords: Noninflammatory degenerative joint disease
Osteoarthritis
Avascular necrosis
Traumatic arthritis
Partial knee arthroplasty
Unicompartmental knee arthroplasty
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2017-01-27
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Oxford Knee Score
timeFrame: 10 years
Secondary outcomes:
measure: EQ-5D
timeFrame: 10 years
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Sah Orthopaedic Associates
state: California
city: Golden
country: United States
facility: Panorama Orthopedics & Spine Center
state: Colorado
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush
state: Illinois
city: New Castle
country: United States
facility: Henry County Orthopedics and Sports Medicine
state: Indiana
city: Beverly
country: United States
facility: Sports Medicine North
state: Massachusetts
city: Troy
country: United States
facility: Troy Orthopaedic Associates
state: Michigan
city: Albuquerque
country: United States
facility: New Mexico Orthopaedics
state: New Mexico
city: Columbia
country: United States
facility: Midlands Orthopaedics & Neurosurgery
state: South Carolina
city: Mount Vernon
country: United States
facility: Skagit Regional Clinics-Riverbend
state: Washington
city: Vienna
country: Austria
facility: Orthopädisches Spital Speising
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Marseille
country: France
facility: Marseille University-Hospital Centres
city: Versailles
country: France
facility: Public Hospital of Versailles
city: Augsburg
country: Germany
facility: Hessing Stiftung
city: Berlin
country: Germany
facility: Sana Kliniken Sommerfeld
city: Eisenberg
country: Germany
facility: Waldkrankenhaus Eisenberg
city: Milan
country: Italy
facility: Orthopedic Institute IRCCS
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Madrid
country: Spain
facility: Hospital Alcorcón
city: Umea
country: Sweden
facility: Umea University Hospital
city: Yverdon les Bains
country: Switzerland
facility: Hopital d'Yverdon les Bains
city: Bristol
country: United Kingdom
facility: Avon Orthopaedic Centre, Southmead Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Harrogate
country: United Kingdom
facility: Harrogate and District NHS Foundation Trust
Study officials:
affiliation: Zimmer Biomet
name: Hillary Overholser
role: STUDY_DIRECTOR
References: