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NCT07422662
Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone
Conditions: FemoroAcetabular Impingement
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Istituto Ortopedico Rizzoli
Location: IRCCS Istituto Ortopedico Rizzoli Bologna
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07422662). StuddyBuddy aggregates publicly available trial information.