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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT02623660
Eligibility Criteria:
Inclusion Criteria:
1. Patients must be scheduled for a primary total knee replacement surgery
2. Age: 18 - 80 years old
3. Males/Females all ethnicities
4. Must have a minimum serum albumin of 4 and a minimum Hgb of 11
5. Ability to mark appropriately the visual analog scales, keep a log of symptoms, medication use, and ODIN1® use
6. Ability to understand all instructions and the informed consent document before signing it
Exclusion Criteria:
1. Subject younger than 18 years of age
2. Any patient with an electrically implanted device such as a pacemaker, neural stimulator, etc.
3. Subject has any known neoplasms
4. A demonstrated lack of compliance as determined by the Principal Investigator, nurse, or wound care specialist
5. Current participation in another clinical study of an investigational device or drug.
6. Any other condition or finding, which in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol
7. Subject unwilling or unable to provide informed consent
8. Subjects receiving any medication or having any condition that significantly interferes with the healing process such as a patient taking systemic steroids or immune suppressants or patient has diabetes mellitus with an HbA1c of greater than 7.5, etc.
9. Any female who has experienced menstruation and is less than 5 years postmenopausal shall have a urine pregnancy test before the initial treatment. An additional test will be performed at 3 weeks from the initial treatment date. Any subject with a positive pregnancy test shall be excluded
10. Subjects with significant peripheral extremity lymph edema
11. Subjects with Stage III or IV peripheral vascular disease, as defined by the Fontaine stages
12. Subjects with venous insufficiencies of Class III or greater, as defined by the Comprehensive Classification System for Chronic Venous Disorders (CEAP)
13. Subjects with muscle skeletal disorders that are not related to the knee
14. Subjects with uncontrolled Blood Pressure
15. Subjects with neurological disease affecting locomotion
16. Subjects with BMI \> 35
17. Subjects that are active smokers
18. Subjects that live on the second floor or higher without elevator access
19. Subjects must not have had a prior TKA. This study is for Primary TKA patients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02623660
Study Brief:
Protocol Section:
NCT02623660