Trials / Recruiting
RecruitingNCT07191067
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
A Multi-Center Two-Arm, Randomized, Blinded, Sham-Controlled Trial to Determine the Safety and Efficacy of the NOVABLOC System on Postoperative Pain, Functional Recovery and Opioid Use in Patients Undergoing Primary Total Knee Arthroplasty
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Synaptrix, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous radiofrequency electrical nerve stimulation | Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA. |
| DEVICE | Non-therapeutic stimulation | Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes. |
Timeline
- Start date
- 2025-09-30
- Primary completion
- 2026-03-30
- Completion
- 2026-03-30
- First posted
- 2025-09-24
- Last updated
- 2026-02-27
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07191067. Inclusion in this directory is not an endorsement.