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

NCT07422662 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Ortopedico Rizzoli

Phase

Not applicable

Started

2026-09

Last updated

2026-07-01

Condition(s) studied

FemoroAcetabular Impingement

Investigational drug(s) / intervention(s)

Hip arthroscopy + BMAC injectionHip arthroscopy

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).

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).

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

55 Years

Healthy volunteers

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.

Primary outcome measure(s)

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).

Trial sites (1)

Facility	City	Region	Status
IRCCS Istituto Ortopedico Rizzoli	Bologna	Italy

More Istituto Ortopedico Rizzoli trials in Italy

Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement Recruiting

Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design Recruiting

Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis Recruiting

Identification of Circulating Biomarkers Associated With Extracellular Vesicles in Sarcomas Recruiting

Prospective Observational Cohort Study of Cardiac Structure and Function in Children and Adults With Osteogenesis Imperfecta Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07422662 on ClinicalTrials.gov ↗ ← All trials in Italy