Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

Официальное название

Multi-Center Pilot Study to Evaluate Concentrated Bone Marrow Aspirate (cBMA) as a Treatment to Modify Post-Traumatic Osteoarthritis (PTOA) Following Revision Anterior Cruciate Ligament Reconstruction (ACLR)

Обзор

The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

Подробное описание

Anterior cruciate ligament reconstruction (ACLR) surgery is considered a relatively safe and effective procedure, however, up to 18% of grafts will fail and require revision surgery. Some studies have shown that these patients may be at increased risk of worse clinical outcomes, including fast progression toward post-traumatic osteoarthritis (PTOA). This is likely in part due to the inflammatory environment created within the joint. Concentrated bone marrow aspirate (cBMA) is a regenerative medicine therapy that contains soluble factors and connective tissue progenitor cells which may have immunomodulatory and pro-regenerative potential. The use of this therapy in conjunction with standard of care surgical treatment may help reduce the inflammatory microenvironment inside the joint, therefore modifying the conditions that might lead to developing long term complications such as PTOA.

The investigators hypothesize that cBMA treatment at the time of revision ACLR may improve clinical outcomes at 1 year after surgery and reduce the risk of developing PTOA-associated symptoms.

Participants will be randomized to either get a cBMA injection (investigational arm) at the time of surgery or a placebo incision (control arm). Biological specimens (blood, urine, synovial fluid), imaging data, functional tests and patient reported clinical outcomes will be measured at different time points during the study, for up to two years after the surgery. This will allow the investigators to evaluate the effect of cBMA in clinical outcomes. Biological specimens will be analyzed using molecular biology techniques to determine their composition, including the concentration of cells and other inflammatory markers.

Вмешательства

• Биопрепарат Concentrated Bone Marrow Aspirate Injection
  Intraoperatively, bone marrow will be harvested from the iliac crest with a commercial kit, it will then be prepared via centrifugation and an injection of the resulting concentrated product (cBMA) will be administered in the operative knee. cBMA is an autologous biologic product.
• Процедура Sham Incision
  A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.
• Процедура Revision Anterior Cruciate Ligament Reconstruction
  This is the standard-of-care surgical procedure.

Первичные конечные точки

• Change from baseline in patient reported knee pain [Срок оценки: Baseline, 6 weeks, 6 months, 12 months and 24 months post-operative]

Вторичные конечные точки (4)

• Expression of local inflammatory biomarkers [Срок оценки: Baseline and 6 weeks post-operative]
• Concentration of circulating inflammatory biomarkers [Срок оценки: Baseline, 6 weeks and 12 months post-operative]
• Change from baseline in cartilage morphology [Срок оценки: Baseline, 12 months post-operative]
• Change from baseline in articular cartilage relative proteoglycan content and collagen fibril organization [Срок оценки: Baseline, 12 months postoperative]

Критерии участия

Критерии включения

• Males and Females
• Age 18 to 55
• Previous unilateral ACLR (Anterior Cruciate Ligament Reconstruction) within the last 5 years, and identified as having experienced failure of the primary ACLR
• Scheduled to have a revision ACLR surgery, with any graft type (including patellar tendon, hamstring, quad or allograft)
• Able to complete all study procedures and participate in a standardized physical therapy program

Критерии исключения

• History of inflammatory arthritis or joint sepsis
• Prior or concurrent total or sub-total meniscectomy
• Prior or present avascular necrosis of the index knee
• Oral or intra-articular corticosteroid injection within 3 months
• Hyaluronic acid or PRP (Platelet-Rich Plasma) injection within 6 months
• Use of duloxetine, doxycycline, indomethacin, glucosamine and/or chondroitin (ongoing or within 2 months)
• Any clinical or laboratory abnormality greater than grade 3 CTCAE, which in the view of the investigator, will compromise the participant's safety.
• Planned arthroplasty in the index knee

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

Профилактика

Центры проведения

США · 2 центра

• Emory Orthopaedics & Spine Center — Atlanta
• Hospital for Special Surgery — New York

Идентификаторы

NCT: NCT06311513 · 2023-1017 · 1177535

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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