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:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT04076202
Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled to undergo primary total knee replacement:
* with painful and disabled knee joint resulting from any of the following diagnoses:
* Osteoarthritis,
* Traumatic arthritis,
* Rheumatoid arthritis with one or more compartments 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 to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
* A good nutritional state of the patient.
* Full skeletal maturity of the patient, patients who are at least 18 years of age.
* Patients of either sex.
* Consent form read, understood, and signed by patient.
Exclusion Criteria:
* Absolute contraindications include the following diagnoses:
* Infection
* Osteomyelitis
* Previous partial or total prosthetic knee replacement on the operative side
* Skeletal immaturity of the patient
* Sepsis
* Patients who are less than 18 years of age
* 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:
NCT04076202
Study Brief:
Protocol Section:
NCT04076202