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 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT03010605
Eligibility Criteria:
Inclusion Criteria:
1. Subject is able to provide written informed consent.
2. Age 18 - 64 years of age
3. Subject has undergone successful unilateral total knee arthroplasty for degenerative joint disease
4. Subject has access to an Apple device with Bluetooth capability
5. Subject is able to demonstrate the capability of setting up and using an Apple application for remote data collection and transmission
6. Subject is able to demonstrate capability of correctly using the MED device
7. Subject is able to comply with post-operative visits and evaluations
Exclusion Criteria:
1. Subject is scheduled for an index knee revision surgery
2. Subject has pre-operative flexion range of motion less than 110 degrees
3. Subject has a pre-operative flexion contracture greater than 15 degrees.
4. Subject has additional joint replacement surgery scheduled within the six week study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT03010605
Study Brief:
Protocol Section:
NCT03010605