Single-blind Randomized Study on the Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hip disability and Osteoarthritis Outcome Score (HOOS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigating physicians who will clinically evaluate the patients at follow-up visits will be blinded
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Hip arthroscopy + BMAC injection
Arthroscopic procedure with the addition of intra-articular bone marrow infiltration
干预措施: Hip arthroscopy + BMAC injection (Procedure)
Hip arthroscopy
Exclusively arthroscopic treatment
干预措施: Hip arthroscopy (Procedure)
结局指标
主要结局
Hip disability and Osteoarthritis Outcome Score (HOOS)
时间窗: 24 months
It is a standardized questionnaire widely used to assess the condition of patients with musculoskeletal hip disorders and includes an evaluation of pain, walking, and the activities that the patient is able to perform. It consists of 40 items divided into 5 subscales that assess five distinct dimensions relevant to the patient: symptoms, pain, activities of daily living, physical function, sports and leisure activities, and quality of life. The patient must express their opinion through standardized response options based on a 5-point Likert scale (none, mild, moderate, severe, extreme); each response is assigned a score ranging from 0 (no problem) to 4 (extreme problems).
次要结局
- Hip disability and Osteoarthritis Outcome Score (HOOS)(1-3-6-12 months)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(1-3-6-12- 24 months)
- Harris Hip Scale (HHS)(1-3-6-12- 24 months)
- Overall assessment of the treatment(1-3-6-12- 24 months)
- Expectations of treatment efficacy(Baseline)