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.
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;
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;
Parallel
Hip arthroscopy + BMAC injection
Procedure/SurgeryThe 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).
Hip arthroscopy
Procedure/SurgeryThe 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).
Hip disability and Osteoarthritis Outcome Score (HOOS)
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).
Hip disability and Osteoarthritis Outcome Score (HOOS)
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)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
t's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Harris Hip Scale (HHS)
This scale was developed for the evaluation of hip surgery outcomes and is intended to assess various hip disabilities and treatment methods in an adult population. The four sections that make up the questionnaire are: pain, function, absence of deformity, and range of motion. The HHS is a measure of dysfunction, so higher is the score, better is the outcome for the individual. The maximum possible score is 100.
Overall assessment of the treatment
The patient should indicate satisfaction and relative degree with treatment at the scheduled follow-up. All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "", "much better", "somewhat better", "no change", "a little worse" ; "much worse"
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This trial is not recruiting at the moment. You can still explore other options:
