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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT01010269
Eligibility Criteria:
Inclusion Criteria:
* Painful and disabled knee joint resulting form 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, or arthrodesis.
* Need to obtain pain relief and improve function.
* Ability and willingness of the patient to follow instructions, including control of weight and activity level.
* Good nutritional state of the patient.
* Patient must have reached full skeletal maturity.
Exclusion Criteria:
* Infection, sepsis, osteomyelitis, and failure of previous joint replacement.
* Uncooperative patient or patients 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:
21 Years
Study:
NCT01010269
Study Brief:
Protocol Section:
NCT01010269