Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSynaptrix, Inc.
About this trial
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 criteria
Qualifiers
Male or non-pregnant females age ≥ 21 years of age;
Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines;
Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI);
Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days.
Disqualifiers
Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure;
Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure;
History of substance abuse or misuse;
History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities);
Trial design
Treatments tested in this trial
- Percutaneous radiofrequency electrical nerve stimulation
- Non-therapeutic stimulation
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov