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:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT00579059
Eligibility Criteria:
Inclusion Criteria:
Identical to the indications stated in the FDA approved labeling for the device (cleared in 510(k) K991753,
K984623, K993159, K010027). These indications are stated below:
* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus, or posttraumatic deformity.
* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
Patient selection factors to be considered include:
* need to obtain pain relief and improve function,
* ability and willingness of the patient to follow instructions, including control of weight and activity level,
* a good nutritional state of the patient,
* the patient must have reached full skeletal maturity.
* Porous coated knee joint replacement prostheses have not been approved for non-cemented applications in the United States.
Exclusion Criteria:
Identical to the contraindications stated in the FDA approved labeling for the device (cleared in 510(k) K991753, K984623, K993159, K010027's). These contraindications are stated below:
Absolute contraindications include:
* infection,
* sepsis
* osteomyelitis.
Relative contraindications include:
* uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis,
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00579059
Study Brief:
Protocol Section:
NCT00579059