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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT03064334
Eligibility Criteria:
Inclusion Criteria:
* Patients who have undergone primary unilateral total knee arthroplasty within the last year.
* Maximum post-operative achievement is between one and two years.
* Patients can read and understand English, non-English speaking patients will be excluded from the study to avoid any language barrier.
* Purposive sampling will be used to recruit the most relevant patients to answer the research questions such as;
* mixed genders to explore gender-experience differences.
* mixed work and retired to explore return to work barriers
* patients with family support and patients living alone to explore the value of family support or home-care services
* mixed educational levels to explore educational background effects.
So there will be no age, gender, social, work status or educational level limitations (Schwandt, 2001)
Exclusion Criteria:
There are possible complications or they present with other pathological conditions that might change recovery progression, they will be excluded to minimize confounding factors and their effects on patients' experiences and outcomes, such as:
* They have undergone bilateral knee arthroplasty, unilateral knee revision surgery, post-traumatic or unicompartmental knee replacement.
* They cannot read and understand English.
* Their function is limited due to musculoskeletal involvements other than unilateral knee osteoarthritis.
* They have been diagnosed with uncontrolled diabetes mellitus or blood pressure.
* Post-TKR they are in pathological groups, such as having neurological disorders (stroke, Parkinson's disease etc.), haemophilia or psychological pathologies.
* They are morbidly obese and have a body mass index (BMI) greater than 40.
* They have advanced osteoporosis or some other unstable chronic disease.
* They have been diagnosed with peripheral vascular disease or an uncontrolled cardiac disease.
* They present with major postoperative complications, such as infection, fracture, acute myocardial infarction, stroke, pulmonary embolism or deep-vein thrombosis.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03064334
Study Brief:
Protocol Section:
NCT03064334