Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01469806
Eligibility Criteria:
Inclusion Criteria:
* Patient is greater than 18 years of age;
* Patient selection is without bias to race or gender;
* Patient is in stable health and able to undergo surgery;
* Patient has patellofemoral joint(s) affected by disease process and/or injury and qualifying for primary unilateral or bilateral replacement of the femoral trochlea based a primary diagnosis of at least one of the following:
* Osteoarthritis
* Traumatic Arthritis
* Polyarthritis
* Severe Chondrocalcinosis
* Salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation)
* History of patellar dislocation or patella fracture
* Dysplasia-induced patellofemoral degeneration
* Patient is willing and able to cooperate in prescribed post-operative therapy;
* Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;
* Patient has participated in the Informed Consent process and has signed an IRB approved Informed Consent.
* Patient has not history of previous prosthetic replacement device(s) of any type in the affected knee joint;
* Independent of study participation, patient is scheduled to receive treatment using a Zimmer Gender Solutions Patellofemoral Joint Prosthesis (PFJ).
Exclusion Criteria:
* Patient with an acute, chronic, local or systemic infection;
* Patient is skeletally immature;
* Patient is pregnant;
* Patient is a prisoner, mentally incompetent or anticipated to be non-compliant. Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.;
* Patient has Rheumatoid Arthritis (RA) AND an ulcer of the skin OR a history of recurrent breakdown of the skin;
* Patient has neuropathic arthropathy, neuromuscular disorder, neurologic condition, vascular disorder, systemic disease and/or other condition that affects lower limb function and/or could contribute to prosthesis instability, prosthesis fixation failure, and/or complications in postoperative care;
* Patient has a Body Mass Index (BMI) greater than 40;
* Patient has insufficient native bone stock in the operative joint (e.g. osteoporosis, osteonecrosis, tumors, cysts, etc.). Note: Bone void fillers are NOT considered native bone stock, even if autograft is used;
* Patient has severe instability, maltracking, or malalignment of the patella, patellofemoral, and/or tibiofemoral joints;
* Patient has patellectomy of the affected joint, including previous patellectomy, patellectomy performed simultaneous to study PFA, or scheduled patellectomy;
* Patient has insufficient menisci and/or ligament structures (e.g. non-functional/absent ACL and/or PCL);
* Patient exhibits tibiofemoral degeneration and/or Outerbridge grade greater than or equal to 3 in EITHER:
* one (medial or lateral) tibiofemoral compartment that is not treated with a simultaneous compatible Zimmer unicompartmental knee replacement; OR
* both (medial AND lateral) tibiofemoral compartments, regardless of treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01469806
Study Brief:
Protocol Section:
NCT01469806