FemoroAcetabular Impingement
Conditions
Keywords
BMAC injection, hip arthroscopy, Acetabular labral tears
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHip 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).
PROCEDUREHip 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).
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigating physicians who will clinically evaluate the patients at follow-up visits will be blinded
Intervention model description
Single-blind randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged between 18 and 55; 2. 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); 3. MRI of the pelvis showing suspected acetabular labral tear; 4. Ability and consent of patients to actively participate in the rehabilitation protocol and clinical follow-up; 5. Signature of informed consent.
Exclusion criteria
1. Patients incapable of understanding and willing; 2. Diagnosis of leukemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy; 3. 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; 4. Patients with uncontrolled diabetes mellitus; 5. Patients with uncontrolled thyroid metabolic disorders; 6. Patients who abuse alcohol, drugs, or medications; 7. Body Mass Index \> 40; 8. Pregnancy or breastfeeding, or intention to become pregnant during the study period. 9. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening. 10. Patients who have undergone hip surgery in the previous 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip disability and Osteoarthritis Outcome Score (HOOS) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hip disability and Osteoarthritis Outcome Score (HOOS) | 1-3-6-12 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) |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 1-3-6-12- 24 months | 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) | 1-3-6-12- 24 months | 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 | 1-3-6-12- 24 months | 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" |
| Expectations of treatment efficacy | Baseline | The patient should indicate at baseline what benefits they expect from the treatment.The patient should choose one of the following options:"Full recovery," "definitely better","much better", "somewhat better", "no change". |
Countries
Italy
Contacts
CONTACTEnrico Tassinari, MD
CONTACTRoberta Licciardi, MSc
PRINCIPAL_INVESTIGATOREnrico Tassinari, MD
IRCCS Istituto Ortopedico Rizzoli
Outcome results
None listed