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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Worst Pain at Day 10 [Срок оценки: 10 days post-TKA]

Вторичные конечные точки (1)

• Total morphine equivalents used [Срок оценки: 5 days post-TKA]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 5 центров

• 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

Идентификаторы

NCT: NCT07191067 · 1-25-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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