Actively Recruiting
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Led by Synaptrix, Inc. · Updated on 2026-04-20
120
Participants Needed
4
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant females age 63 21 years
- Diagnosis of osteoarthritis requiring primary unilateral total knee arthroplasty
- Able and willing to provide informed consent and authorization for release of protected health information
- Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days
- Able to read and understand instructions and information presented in English
You will not qualify if you...
- Chronic opioid use averaging 63 30 oral morphine equivalents per day within 30 days before TKA
- Use of extended-release or long-acting opioids within 30 days before TKA
- History of substance abuse or misuse
- Significant cardiac disease such as ejection fraction 64 50%, recent coronary intervention, or valvular abnormalities
- Prior radiofrequency ablation or cryotherapy on the operative knee
- Prior total knee arthroplasty on the operative knee
- Body mass index over 40
- Neurological, neuromuscular, or neuropathic disease that could affect study results
- Presence of active implanted biomedical devices like pacemakers or cochlear stimulators
- History of hip or knee dislocation or fractures on the operative leg
- Sepsis or systemic/local infections where the procedure is performed
- Medical or psychiatric illnesses compromising evaluation or treatment, including high anxiety or depression scores
- Pregnant, planning pregnancy, or breastfeeding
- Uncontrolled diabetes with A1C over 7.5%
- History of bleeding disorders
- Participation in another clinical trial within 45 days prior to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center
Daphne, Alabama, United States, 36526
Actively Recruiting
2
Premier Orthopaedic and Trauma Specialists
Upland, California, United States, 91786
Not Yet Recruiting
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27517
Actively Recruiting
4
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
D
Daniel Guerrero
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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