Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Purpose
Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.
Condition
- Pain
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or non-pregnant females age ≥ 21 years of age; 2. Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines; 3. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI); 4. Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days. 5. Able to read and understand instructions and information presented in English.
Exclusion Criteria
- Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure; 2. Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure; 3. History of substance abuse or misuse; 4. History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities); 5. Prior radiofrequency ablation or cryotherapy for pain on the operative knee; 6. Prior TKA on the operative knee; 7. BMI > 40; 8. History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions; 9. Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear [ear] stimulator); 10. History of hip or knee dislocation or bone fractures on the operative leg; 11. Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin; 12. Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score >10) or depression (PHQ-9 score >15); 13. Pregnant, actively planning a pregnancy or breast-feeding a child; 14. Uncontrolled diabetes (A1C > 7.5%); 15. History of bleeding disorder; 16. Participating in another clinical trial/investigation within 45 days prior to signing informed consent.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator NOVABLOC Stimulation |
Subjects will receive NOVABLOC stimulation prior to their TKA |
|
|
Sham Comparator Sham Stimulation |
Subject will receive sham non-therapeutic stimulation |
|
Recruiting Locations
Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center
Daphne, Alabama 36526
Daphne, Alabama 36526
University of North Carolina
Chapel Hill, North Carolina 27517
Chapel Hill, North Carolina 27517
Virginia Mason Medical Center
Seattle, Washington 98101
Seattle, Washington 98101
More Details
- Status
- Recruiting
- Sponsor
- Synaptrix, Inc.