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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT03994250
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the age of 22 and 80 years inclusive
* Diagnosis of non-inflammatory degenerative joint disease
* Suitable candidate for cemented primary total knee arthroplasty
* Voluntary, informed consent to participate in the study
* Subject is not currently bedridden
* Able to understand (in the opinion of the clinical investigator) the clinical investigation and co-operate with clinical investigations
* Subject is able to comfortably speak, read and understand questions
Exclusion Criteria:
* Females who are pregnant or lactating
* Contralateral knee already enrolled in the study
* Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee
* Contralateral amputation
* Currently experiencing radicular pain from the spine
* Participated in a study with an investigational product in the last 3 months
* Currently involved in any personal injury litigation, medical-legal or workers compensation claims
* Known drug or alcohol abuser or a psychological disorder that could affect their ability to complete patient reported questionnaires
* Diagnosed with fibromyalgia that is currently being treated with prescription medication
* Significant neurological or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease)
* Suffering with inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis,psoriatic arthritis, systemic lupus erythematosus
* Medical condition with less than 2 years life expectancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT03994250
Study Brief:
Protocol Section:
NCT03994250