NCT07422662

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

Single-blind Randomized Study on the Arthroscopic Treatment of Acetabular Labral Lesions: Intrarticular Injection of Bone Marrow vs Hip Arthroscopy Alone

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• FemoroAcetabular Impingement

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	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).

Timeline

• Start date: 2026-04-01
• Primary completion: 2032-04-01
• Completion: 2032-04-01
• First posted: 2026-02-20
• Last updated: 2026-02-23

Locations

1 site across 1 country: Italy