Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Synaptrix, Inc.
Study ID
NCT07191067
Status
Recruiting
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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Percutaneous radiofrequency electrical nerve stimulation — DEVICE
    Percutaneous radiofrequency electrical nerve stimulation will be applied to the femoral and sciatic nerves prior to TKA.
  • Non-therapeutic stimulation — DEVICE
    Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.

Study Details

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.

Key Dates

Start date
Sep 30, 2025
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: NOVABLOC Stimulation
    Subjects will receive NOVABLOC stimulation prior to their TKA
  • Sham Comparator: Sham Stimulation
    Subject will receive sham non-therapeutic stimulation

Primary Outcome Measure

Worst Pain at Day 10 [ Time Frame: 10 days post-TKA ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Alabama Orthopedic Sports Medicine & Baldwin County Surgery CenterDaphneAlabama36526
Natalia Alexeeva, PhD
[email protected]
315-395-3300
Daniel Matthews, MD (PRINCIPAL_INVESTIGATOR)
Premier Orthopaedic and Trauma SpecialistsUplandCalifornia91786
Nirav Amin, MD
[email protected]
Nirav Amin, MD (PRINCIPAL_INVESTIGATOR)
University of North CarolinaChapel HillNorth Carolina27517
Karen Van Manen
[email protected]
Stuart Grant, MD (PRINCIPAL_INVESTIGATOR)
Southern Oregon OrthopedicsMedfordOregon97504
Natalia Alexeeva, PhD
[email protected]
315-395-3300
Jeffrey Jancuska, MD (PRINCIPAL_INVESTIGATOR)
Virginia Mason Medical CenterSeattleWashington98101
Leslie Stevens
[email protected]
David Auyong, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Daphne, AL

By research site
Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center· Daphne, ALPremier Orthopaedic and Trauma Specialists· Upland, CAUniversity of North Carolina· Chapel Hill, NCSouthern Oregon Orthopedics· Medford, ORVirginia Mason Medical Center· Seattle, WA

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