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FemoroAcetabular ImpingementNCT07422662

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

A study testing Hip arthroscopy + BMAC injection and Hip arthroscopy in people with FemoroAcetabular Impingement, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
FemoroAcetabular Impingement
What is being tested?
Hip arthroscopy + BMAC injection and Hip arthroscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteItaly
Study dates
Sep 2026to Apr 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Enrico Tassinari, MD contact

0516366122

enrico.tassinari@ior.it

Roberta Licciardi, MSc contact

0516366567

roberta.licciardi@ior.it

Italy1 site
  • IRCCS Istituto Ortopedico Rizzoli

    Bologna, 40136

    Enrico Tassinari, MD, 0516366122, enrico.tassinari@ior.it

    Roberta Licciardi, MSc, 0516366567, roberta.licciardi@ior.it

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Hip arthroscopy + BMAC injection, Hip arthroscopy
Keywords
BMAC injection, hip arthroscopy, Acetabular labral tears
Medical subject headings
Femoracetabular Impingement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hip arthroscopy + BMAC injectionProcedure or surgery

    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 arthroscopyProcedure or surgery

    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 groups in NCT07422662
Study groupRoleWhat they receive
Hip arthroscopy + BMAC injectionExperimentalArthroscopic procedure with the addition of intra-articular bone marrow infiltration
Receives: Procedure: Hip arthroscopy + BMAC injection
Hip arthroscopyActive comparatorExclusively arthroscopic treatment
Receives: Procedure: Hip arthroscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 24 months

Secondary outcomes (5)
  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)

    Measured: 1-3-6-12 months

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    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

    Measured: 1-3-6-12- 24 months

  3. Harris Hip Scale (HHS)

    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.

    Measured: 1-3-6-12- 24 months

  4. Overall assessment of the treatment

    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"

    Measured: 1-3-6-12- 24 months

  5. Expectations of treatment efficacy

    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".

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionApr 2032 (estimated)
  4. Study completionApr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-blind randomized trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07422662
Sponsor's protocol ID
BoneMarrowHip
Status last verified
Jun 2026
First submitted
13 Feb 2026
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23306713
  • 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.

    PubMed 19228082
  • 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.

    PubMed 23738292
  • 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.

    PubMed 21403984
  • 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.

    PubMed 22176711
  • 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.

    PubMed 20511439
  • 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.

    PubMed 30377577
  • 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.

    PubMed 36574821
  • 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.

    PubMed 34648479
  • 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.

    PubMed 30957569
  • 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.

    PubMed 34901293
  • 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.

    PubMed 38792921
  • 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.

    PubMed 30226992

Questions about this trial

What is this clinical trial studying?

A study testing Hip arthroscopy + BMAC injection and Hip arthroscopy in people with FemoroAcetabular Impingement, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Enrico Tassinari, MD (0516366122, enrico.tassinari@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hip disability and Osteoarthritis Outcome Score (HOOS) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07422662, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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