Persona Partial Knee Clinical Outcomes Study

NCT03034811 | Active Not Recruiting FDA Device

• 1 other identifier: K.CR.I.G.16.16
• Study Type: interventional
• Target: 757
• Locations: 10 countries
• Sites: 24

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.

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

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score

  A Patient reported functional outcome score for knee arthroplasty

  10 years

Secondary Outcomes (1)

• EQ-5D

  10 years

Study Arms (1)

PPK subjects

OTHER

Subjects that receive the Persona Partial Knee system

Device: Persona Partial Knee system

Interventions

Persona Partial Knee system DEVICE

Fixed bearing partial knee

PPK subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (24)

Sah Orthopaedic Associates

Fremont, California, 94538, United States

Location

Panorama Orthopedics & Spine Center

Golden, Colorado, 80401, United States

Location

Midwest Orthopaedics at Rush

Chicago, Illinois, 60612, United States

Location

Henry County Orthopedics and Sports Medicine

New Castle, Indiana, 47362, United States

Location

Sports Medicine North

Beverly, Massachusetts, 01960, United States

Location

Troy Orthopaedic Associates

Troy, Michigan, 48084, United States

Location

New Mexico Orthopaedics

Albuquerque, New Mexico, 87106, United States

Location

Midlands Orthopaedics & Neurosurgery

Columbia, South Carolina, 29201, United States

Location

Skagit Regional Clinics-Riverbend

Mount Vernon, Washington, 98273, United States

Location

Orthopädisches Spital Speising

Vienna, Austria

Location

Cliniques Universitaires Saint-Luc

Woluwe-Saint-Lambert, Belgium

Location

Marseille University-Hospital Centres

Marseille, France

Location

Public Hospital of Versailles

Versailles, France

Location

Hessing Stiftung

Augsburg, Germany

Location

Sana Kliniken Sommerfeld

Berlin, Germany

Location

Waldkrankenhaus Eisenberg

Eisenberg, Germany

Location

Orthopedic Institute IRCCS

Milan, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Hospital Alcorcón

Madrid, Spain

Location

Umea University Hospital

Umeå, Sweden

Location

Hopital d'Yverdon les Bains

Yverdon-les-Bains, Switzerland

Location

Avon Orthopaedic Centre, Southmead Hospital

Bristol, United Kingdom

Location

Royal Derby Hospital

Derby, United Kingdom

Location

Harrogate and District NHS Foundation Trust

Harrogate, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hillary Overholser

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 27, 2017
• Study Start: February 8, 2017
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (1); FR (2); CH (1); ES (1); DE (3); SE (1); US (9); IT (2); GB (3)