Pain
Conditions
Brief 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.
Interventions
DEVICEPercutaneous radiofrequency electrical nerve stimulation
Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.
DEVICENon-therapeutic stimulation
Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.
Sponsors
Synaptrix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine equivalents used | 5 days post-TKA | Total morphine equivalents used cumulatively through Day 5 |
Countries
United States
Contacts
CONTACTDaniel Guerrero
Outcome results
None listed