ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain

Официальное название

ReneuRx™ (Nerve Selective Therapy) Utilized in Lateral Hip Pain: A Multi-Center, Randomized, Controlled Trial (RENEU)

Обзор

The goal of this clinical trial is to evaluate the safety and analgesic performance of the ReneuRx™ device in subjects with moderate to severe chronic lateral hip pain compared to subjects receiving treatment with corticosteroid injection in adults aged 22-80 years. Participants will attend study visits and complete quality of life questionnaires. Participants will be followed for approximately 6-12 months after the study procedure.

Вмешательства

• Препарат Triamcinolone acetate
  A single 40mg Triamcinolone dose, prepared as 1ml of steroid mixed with 4ml of saline, of which 3-5ml is injected.
• Устройство ReneuRx
  ReneuRx will be injected around the trochanteric branches of the femoral nerve.

Первичные конечные точки

• Primary Effectiveness [Срок оценки: 3-months post treatment]
• Primary Safety [Срок оценки: Through study completion, an average of 12-months]

Вторичные конечные точки (5)

• Secondary Effectiveness [Срок оценки: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month]
• Secondary Effectiveness [Срок оценки: 3 month and 6 month post-treatment]
• Secondary Effectiveness [Срок оценки: Baseline, Day 7, 1-Month, 2-Month, 3-Month, 4-Month, 5-Month, 6-Month, 12-Month]
• Secondary Effectiveness [Срок оценки: 12 months post-treatment]
• Pain Relief [Срок оценки: 6-Month, 12-Month]

Критерии участия

Критерии включения

• Age 22 to 80, inclusive of any gender
• Baseline pain intensity of >5 of the Numeric Rating Scale (NRS) localized to the lateral aspect of the hip (with or without radiation to lateral thigh or buttock) despite current treatment
• Tenderness to palpation of the peritrochanteric space of the lateral hip in adults with Greater Trochanteric Pain Syndrome.
• At least 6 months of previous conservative treatments for subject's lateral hip pain (NSAID, acetaminophen, physical therapy, and/or cortisone injections) that are not currently providing relief
• Agree to see study investigator and study team for hip pain during the study period
• Willing/able to understand the informed consent form and provide written informed consent
• Able to complete outcome measures (including electronic patient reported outcome measures)

Критерии исключения

• Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
• History of cryoglobulinemia
• History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
• History of cold urticaria
• History of Chilblain's (pernio) disease in the lower extremities
• History of Raynaud's disease
• Open and/or infected wounds or active tumor at or near the treatment site
• History of vascular surgery involving femoral vessels on theinjection side
• History of hip surgery of any kind to the index side within the past 6 months (e.g., arthroscopy, arthroplasty, etc.)
• History of trochanteric osteotomy, femoral osteotomy, amputation, or pseudoarthrosis.
• Active bacterial or fungal infection that, at the discretion of the investigator, would preclude study participation
• Currently taking >60 MME/day
• History of systemic inflammatory conditions such as rheumatoid arthritis
• Bleeding disorders, unless appropriately stopped or reversed for the procedure at investigator's discretion
• Any neuropathic pain condition (e.g. - complex regional pain syndrome, lumbar radiculopathy) in the area of pain
• Presence of unstable psychiatric disease
• Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index hip(s) within the past 12 months
• Corticosteroid injection within the previous 3 months or orthobiologic therapy such as platelet rich plasma injections, or shockwave therapy for the index hip(s) within the previous 6 months
• Known contraindication to use of a regional anesthetic block
• Pregnant, nursing, or intent of becoming pregnant during the study period
• Documented evidence of an overlapping pain pattern from another source that the Investigator believes to be indistinguishable from lateral hip pain
• Lumbar or sacroiliac fusion within the previous 6 months
• Any other condition (such as history of deep vein thrombosis, significant cardiovascular, renal failure/dialysis, hepatic or other systemic comorbidity/chronic pain condition including cancer) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data
• Body habitus/hip anatomy that would preclude the use of the product injection needle size
• Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
• Pending litigation or disability status
• Unwilling to refrain from any scheduled surgeries that would impact the collection of study endpoint data during the duration of the study
• Subject is a prisoner

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

Простое слепое

Основная цель

Лечение

Центры проведения

США · 11 центров

• Healthcare Outcomes Performance Company — Sun City
• Emory Orthopedics and Spine Center — Johns Creek
• Ochsner Health Center — New Orleans
• Skylight Health Research — Burlington
• Mass General Brigham — Chestnut Hill
• Virtua Health — Sewell
• The Orthopaedic Center — Tulsa
• Rothman Orthopaedics — King of Prussia
• … и ещё 3 центра

Идентификаторы

NCT: NCT07568015 · BTX-786-GTPS-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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