Persona Partial Knee Clinical Outcomes Study (NCT03034811) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Persona Partial Knee Clinical Outcomes Study
United States757 participantsStarted 2017-02-08
Plain-language summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.
Who can participate
Age range18 Years
SexALL
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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 …