Clinical Trials in Mexico / NCT03034811
Active, not recruiting
Not applicable
Persona Partial Knee Clinical Outcomes Study
NCT03034811 · tracked via the Priya Life Science Mexico tracker
Condition(s) studied
OsteoarthritisAvascular NecrosisTraumatic ArthritisConditional Tibial Condyle or Plateau FracturesConditional Revision of the Articular Surface
Investigational drug(s) / intervention(s)
Persona Partial Knee system
Persona Partial Knee system: Fixed bearing partial knee
Study summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
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.)
Primary outcome measure(s)
- Oxford Knee Score — 10 years
A Patient reported functional outcome score for knee arthroplasty
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Sah Orthopaedic Associates | Fremont | California | |
| Panorama Orthopedics & Spine Center | Golden | Colorado | |
| Midwest Orthopaedics at Rush | Chicago | Illinois | |
| Henry County Orthopedics and Sports Medicine | New Castle | Indiana | |
| Sports Medicine North | Beverly | Massachusetts | |
| Troy Orthopaedic Associates | Troy | Michigan | |
| New Mexico Orthopaedics | Albuquerque | New Mexico | |
| Midlands Orthopaedics & Neurosurgery | Columbia | South Carolina | |
| Skagit Regional Clinics-Riverbend | Mount Vernon | Washington | |
| Orthopädisches Spital Speising | Vienna | Austria | |
| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Belgium | |
| Marseille University-Hospital Centres | Marseille | France | |
| Public Hospital of Versailles | Versailles | France | |
| Hessing Stiftung | Augsburg | Germany | |
| Sana Kliniken Sommerfeld | Berlin | Germany | |
| Waldkrankenhaus Eisenberg | Eisenberg | Germany | |
| Orthopedic Institute IRCCS | Milan | Italy | |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | |
| Hospital Alcorcón | Madrid | Spain | |
| Umea University Hospital | Umeå | Sweden | |
| Hopital d'Yverdon les Bains | Yverdon-les-Bains | Switzerland | |
| Avon Orthopaedic Centre, Southmead Hospital | Bristol | United Kingdom | |
| Royal Derby Hospital | Derby | United Kingdom | |
| Harrogate and District NHS Foundation Trust | Harrogate | United Kingdom |
More Zimmer Biomet trials in Mexico
Prospective G7 Dual Mobility Total Hip PMCF
Active, not recruiting
Persona Ti-Nidium Post-Market Clinical Follow-up
Active, not recruiting
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Active, not recruiting
Other trials for the same condition
Persona Ti-Nidium Post-Market Clinical Follow-up
Active, not recruiting
A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee
Active, not recruiting
Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03034811 on ClinicalTrials.gov ↗ ← All trials in Mexico