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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT02820766
Eligibility Criteria:
Inclusion Criteria:
* Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith \& Nephew Posterior Stabilized Knee System
* Will be initiating outpatient PT ≤ 7 days post-operatively
* Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis
* Has pre-operative ROM ≥ 90°
* Is skeletally mature in the PI judgment
* Is 21 years of age of older
* Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires
* Has consented to participate in the study by signing the IRB/EC approved informed consent for the study
* Agrees to follow post- operative physical therapy program
Exclusion Criteria:
* Significant preoperative varus or valgus deformities (\>15º)
* Has received a constrained or deep dish tibial insert
* Morbid obesity (BMI \> 40)
* Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit
* Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection
* Fibromyalgia requiring treatment
* Current or impending incarceration or is a prisoner
* In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
* Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
* Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement
* Requires a Legally Authorized Representative to consent to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02820766
Study Brief:
Protocol Section:
NCT02820766