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

NCT07422662 | Not Yet Recruiting

• 1 other identifier: BoneMarrowHip
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

FemoroAcetabular Impingement

Keywords

BMAC injection; hip arthroscopy; Acetabular labral tears

Outcome Measures

Primary Outcomes (1)

• 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).

  24 months

Secondary Outcomes (5)

• Hip disability and Osteoarthritis Outcome Score (HOOS)

  1-3-6-12 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  1-3-6-12- 24 months

• Harris Hip Scale (HHS)

  1-3-6-12- 24 months

• Overall assessment of the treatment

  1-3-6-12- 24 months

• Expectations of treatment efficacy

  Baseline

Study Arms (2)

Hip arthroscopy + BMAC injection

EXPERIMENTAL

Arthroscopic procedure with the addition of intra-articular bone marrow infiltration

Procedure: Hip arthroscopy + BMAC injection

Hip arthroscopy

ACTIVE COMPARATOR

Exclusively arthroscopic treatment

Procedure: Hip arthroscopy

Interventions

Hip arthroscopy + BMAC injection PROCEDURE

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 + BMAC injection

Hip arthroscopy PROCEDURE

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).

Hip arthroscopy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Signature of informed consent.

You may not qualify if:

• 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;
• Patients with uncontrolled thyroid metabolic disorders;
• Patients who abuse alcohol, drugs, or medications;
• Body Mass Index \> 40;
• Pregnancy or breastfeeding, or intention to become pregnant during the study period.
• Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
• Patients who have undergone hip surgery in the previous 12 months.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (13)

• Filardo G, Madry H, Jelic M, Roffi A, Cucchiarini M, Kon E. Mesenchymal stem cells for the treatment of cartilage lesions: from preclinical findings to clinical application in orthopaedics. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1717-29. doi: 10.1007/s00167-012-2329-3. Epub 2013 Jan 11.

  PMID: 23306713 BACKGROUND

• Caplan AI. New era of cell-based orthopedic therapies. Tissue Eng Part B Rev. 2009 Jun;15(2):195-200. doi: 10.1089/ten.TEB.2008.0515.

  PMID: 19228082 BACKGROUND

• Via AG, Frizziero A, Oliva F. Biological properties of mesenchymal Stem Cells from different sources. Muscles Ligaments Tendons J. 2012 Oct 16;2(3):154-62. Print 2012 Jul.

  PMID: 23738292 BACKGROUND

• Fortier LA, Barker JU, Strauss EJ, McCarrel TM, Cole BJ. The role of growth factors in cartilage repair. Clin Orthop Relat Res. 2011 Oct;469(10):2706-15. doi: 10.1007/s11999-011-1857-3.

  PMID: 21403984 BACKGROUND

• Song Y, Ito H, Kourtis L, Safran MR, Carter DR, Giori NJ. Articular cartilage friction increases in hip joints after the removal of acetabular labrum. J Biomech. 2012 Feb 2;45(3):524-30. doi: 10.1016/j.jbiomech.2011.11.044. Epub 2011 Dec 15.

  PMID: 22176711 BACKGROUND

• Safran MR. The acetabular labrum: anatomic and functional characteristics and rationale for surgical intervention. J Am Acad Orthop Surg. 2010 Jun;18(6):338-45. doi: 10.5435/00124635-201006000-00006.

  PMID: 20511439 BACKGROUND

• Stelzer JW, Martin SD. Use of Bone Marrow Aspirate Concentrate with Acetabular Labral Repair for the Management of Chondrolabral Junction Breakdown. Arthrosc Tech. 2018 Sep 1;7(10):e981-e987. doi: 10.1016/j.eats.2018.06.003. eCollection 2018 Oct.

  PMID: 30377577 BACKGROUND

• Day MA, Hancock KJ, Selley RS, Olsen R, Ranawat AS, Nwachukwu BU, Kelly BT, Nawabi DH. Hip Arthroscopy With Bone Marrow Aspirate Injection for Patients With Symptomatic Labral Tears and Early Degenerative Changes Shows Similar Improvement Compared With Patients Undergoing Hip Arthroscopy With Symptomatic Labral Tears Without Arthritis. Arthroscopy. 2023 Jun;39(6):1429-1437. doi: 10.1016/j.arthro.2022.12.012. Epub 2022 Dec 24.

  PMID: 36574821 BACKGROUND

• Martin SD, Kucharik MP, Abraham PF, Nazal MR, Meek WM, Varady NH. Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. J Bone Joint Surg Am. 2022 Jan 5;104(1):4-14. doi: 10.2106/JBJS.20.01740.

  PMID: 34648479 BACKGROUND

• Rivera E, Seijas R, Rubio M, Garcia-Balletbo M, Vilar JM, Boada PL, Cugat R. Outcomes at 2-Years Follow-Up After Hip Arthroscopy Combining Bone Marrow Concentrate. J Invest Surg. 2020 Aug;33(7):655-663. doi: 10.1080/08941939.2018.1535010. Epub 2019 Apr 7.

  PMID: 30957569 BACKGROUND

• Kucharik MP, Abraham PF, Nazal MR, Varady NH, Eberlin CT, Meek WM, Naessig SA, Martin SD. Treatment of Full-Thickness Acetabular Chondral Flaps During Hip Arthroscopy: Bone Marrow Aspirate Concentrate Versus Microfracture. Orthop J Sports Med. 2021 Dec 7;9(12):23259671211059170. doi: 10.1177/23259671211059170. eCollection 2021 Dec.

  PMID: 34901293 BACKGROUND

• Firat A, Veizi E, Koutserimpas C, Alkan H, Sahin A, Guven S, Erdogan Y. Extended Interportal Capsulotomy for Hip Arthroscopy, a Single-Center Clinical Experience. Medicina (Kaunas). 2024 Apr 29;60(5):738. doi: 10.3390/medicina60050738.

  PMID: 38792921 BACKGROUND

• Flores SE, Sheridan JR, Borak KR, Zhang AL. When Do Patients Improve After Hip Arthroscopy for Femoroacetabular Impingement? A Prospective Cohort Analysis. Am J Sports Med. 2018 Nov;46(13):3111-3118. doi: 10.1177/0363546518795696. Epub 2018 Sep 18.

  PMID: 30226992 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico Tassinari, MD

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Tassinari, MD

CONTACT

0516366122; enrico.tassinari@ior.it

Roberta Licciardi, MSc

CONTACT

0516366567; roberta.licciardi@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigating physicians who will clinically evaluate the patients at follow-up visits will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind randomized trial

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: February 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)