Active, not recruiting
Not applicable
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Condition(s) studied
Pain
Investigational drug(s) / intervention(s)
Percutaneous radiofrequency electrical nerve stimulationNon-therapeutic stimulation
Percutaneous radiofrequency electrical nerve stimulation: Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.
Non-therapeutic stimulation: Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.
Study summary
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.
Eligibility
Inclusion Criteria:
1. 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:
1. 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.
Primary outcome measure(s)
- Worst Pain at Day 10 — 10 days post-TKA
The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)
Trial sites (5)
| Facility | City | Region | Status |
| Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center |
Daphne |
Alabama |
|
| UBMD Orthopedics and Sports Medicine |
Williamsville |
New York |
|
| University of North Carolina |
Chapel Hill |
North Carolina |
|
| Southern Oregon Orthopedics |
Medford |
Oregon |
|
| Virginia Mason Medical Center |
Seattle |
Washington |
|
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