Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone

Официальное название

Single-blind Randomized Study on the Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone

Обзор

The BoneMarrowHip study is a single-blind, randomized, single-center trial. Through this study, the clinical results of patients treated during hip arthroscopy surgery with autologous bone marrow infiltration taken from the ipsilateral iliac crest will be evaluated and compared, comparing the outcomes with a group of patients undergoing the same surgical treatment but without intra-articular infiltration. All selected patients have acetabular labral tears diagnosed by MRI imaging. In addition, the study will evaluate the safety of the treatment by documenting any adverse events.

Подробное описание

Patients with acetabular labral tears will be included in a randomized, single-blind controlled study in which the clinical results of treatment of the tear using arthroscopic surgery with the addition of intra-articular bone marrow infiltration will be evaluated and compared with treatment using arthroscopic surgery alone.

The The investigating physicians who will clinically evaluate the patients at follow-up visits will be blinded (i.e., unaware of the treatment received by the patient). To this end, the medical staff performing the follow-up visits will be different from those performing the surgical and infiltration procedures. Eighty patients will be included in the study. The selected patient will undergo hip arthroscopy to repair the acetabular labral tear. At the same time, half of the patients, based on randomization, will receive an intra-articular injection of autologous bone marrow concentrate. Following the surgical procedure, follow-up visits will be scheduled at 1, 3, 6, 12, and 24 months after treatment.

At the 1-month follow-up, an X-ray will be performed to assess the possible formation of heterotopic ossification; at the 12-month follow-up, an MRI will be performed to assess the healing of the acetabular labrum. Both imaging tests will be performed according to normal clinical practice. Questionnaires will be administered and clinical assessments will be performed before treatment and during the aforementioned follow-up visits.

Вмешательства

• Процедура Hip arthroscopy + BMAC injection
  The selected patient will undergo hip arthroscopy to repair the acetabular labral tear and, at the same time, the autologous bone marrow concentrate taken from the iliac crest will be injected into the joint. The arthroscopic procedure will involve three access points via millimetric incisions (1-2 mm).
• Процедура Hip arthroscopy
  The selected patient will undergo hip arthroscopy to repair the acetabular labral tear. The arthroscopic procedure will involve three access points via millimetric incisions (1-2 mm).

Первичные конечные точки

• Hip disability and Osteoarthritis Outcome Score (HOOS) [Срок оценки: 24 months]

Вторичные конечные точки (5)

• Hip disability and Osteoarthritis Outcome Score (HOOS) [Срок оценки: 1-3-6-12 months]
• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [Срок оценки: 1-3-6-12- 24 months]
• Harris Hip Scale (HHS) [Срок оценки: 1-3-6-12- 24 months]
• Overall assessment of the treatment [Срок оценки: 1-3-6-12- 24 months]
• Expectations of treatment efficacy [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Male or female patients aged between 18 and 55;
• Pelvic and hip X-ray showing no severe osteoarthritis (defined as advanced osteoarthritis with large osteophytes, chronic fractures or bone remodeling, severe deformity or bone friction, and/or bone-to-bone contact indicative of severe osteoarthritis/complete loss of cartilage);
• MRI of the pelvis showing suspected acetabular labral tear;
• Ability and consent of patients to actively participate in the rehabilitation protocol and clinical follow-up;
• Signature of informed consent.

Критерии исключения

• Patients incapable of understanding and willing;
• Diagnosis of leukemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;
• Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;
• Patients with uncontrolled diabetes mellitus;
• Patients with uncontrolled thyroid metabolic disorders;
• Patients who abuse alcohol, drugs, or medications;
• Body Mass Index > 40;
• Pregnancy or breastfeeding, or intention to become pregnant during the study period.
• Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
• Patients who have undergone hip surgery in the previous 12 months.

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

Италия · 1 центр

• IRCCS Istituto Ortopedico Rizzoli — Bologna

Публикации

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• Caplan AI. New era of cell-based orthopedic therapies. Tissue Eng Part B Rev. 2009 Jun;15(2):195-200. doi: 10.1089/ten.TEB.2008.0515. PMID 19228082
• Via AG, Frizziero A, Oliva F. Biological properties of mesenchymal Stem Cells from different sources. Muscles Ligaments Tendons J. 2012 Oct 16;2(3):154-62. Print 2012 Jul. PMID 23738292
• Fortier LA, Barker JU, Strauss EJ, McCarrel TM, Cole BJ. The role of growth factors in cartilage repair. Clin Orthop Relat Res. 2011 Oct;469(10):2706-15. doi: 10.1007/s11999-011-1857-3. PMID 21403984
• Song Y, Ito H, Kourtis L, Safran MR, Carter DR, Giori NJ. Articular cartilage friction increases in hip joints after the removal of acetabular labrum. J Biomech. 2012 Feb 2;45(3):524-30. doi: 10.1016/j.jbiomech.2011.11.044. Epub 2011 Dec 15. PMID 22176711
• Safran MR. The acetabular labrum: anatomic and functional characteristics and rationale for surgical intervention. J Am Acad Orthop Surg. 2010 Jun;18(6):338-45. doi: 10.5435/00124635-201006000-00006. PMID 20511439
• Stelzer JW, Martin SD. Use of Bone Marrow Aspirate Concentrate with Acetabular Labral Repair for the Management of Chondrolabral Junction Breakdown. Arthrosc Tech. 2018 Sep 1;7(10):e981-e987. doi: 10.1016/j.eats.2018.06.003. eCollection 2018 Oct. PMID 30377577
• Day MA, Hancock KJ, Selley RS, Olsen R, Ranawat AS, Nwachukwu BU, Kelly BT, Nawabi DH. Hip Arthroscopy With Bone Marrow Aspirate Injection for Patients With Symptomatic Labral Tears and Early Degenerative Changes Shows Similar Improvement Compared With Patients Undergoing Hip Arthroscopy With Symptomatic Labral Tears Without Arthritis. Arthroscopy. 2023 Jun;39(6):1429-1437. doi: 10.1016/j.arthro.2 PMID 36574821

Идентификаторы

NCT: NCT07422662 · BoneMarrowHip

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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