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

Official title

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

Overview

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

• 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.

Primary outcome measures

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

Secondary outcome measures (1)

• Total morphine equivalents used [Time frame: 5 days post-TKA]

Eligibility criteria

Inclusion criteria

• 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.
• Able to read and understand instructions and information presented in English.

Exclusion criteria

• 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);
• Prior radiofrequency ablation or cryotherapy for pain on the operative knee;
• Prior TKA on the operative knee;
• BMI > 40;
• History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions;
• Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \[ear\] stimulator);
• History of hip or knee dislocation or bone fractures on the operative leg;
• Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin;
• Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score >10) or depression (PHQ-9 score >15);
• Pregnant, actively planning a pregnancy or breast-feeding a child;
• Uncontrolled diabetes (A1C > 7.5%);
• History of bleeding disorder;
• Participating in another clinical trial/investigation within 45 days prior to signing informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 5 centers

• Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center — Daphne
• Premier Orthopaedic and Trauma Specialists — Upland
• University of North Carolina — Chapel Hill
• Southern Oregon Orthopedics — Medford
• Virginia Mason Medical Center — Seattle

Identifiers

NCT: NCT07191067 · 1-25-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗