ClinicalTrials.gg
Not yet recruitingNCT07422662Updated Jul 1, 2026

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

An interventional study of Hip arthroscopy + BMAC injection and Hip arthroscopy in FemoroAcetabular Impingement, sponsored by Istituto Ortopedico Rizzoli. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

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.

02

Conditions studied

  • FemoroAcetabular Impingement

Keywords

  • BMAC injection
  • hip arthroscopy
  • Acetabular labral tears
03

In context

Femoracetabular Impingement

116 studies on the registry are indexed under Femoracetabular Impingement; 37 are open to participants now.

This study's planned enrollment of 80 is close to the median of 73 across 70 interventional studies indexed under Femoracetabular Impingement.

Browse Femoracetabular Impingement studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  1. Patients incapable of understanding and willing;
  2. Diagnosis of leukemia, known presence of 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; (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. > 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Hip arthroscopy + BMAC injection

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

    Procedure: Hip arthroscopy + BMAC injection

  • Active comparator
    Hip arthroscopy

    Exclusively arthroscopic treatment

    Procedure: Hip arthroscopy

Interventions

  • ProcedureHip 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).

  • ProcedureHip 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).

06

What researchers measure

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).

    Time frame: 24 months

Secondary 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)

    Time frame: 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

    Time frame: 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.

    Time frame: 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"

    Time frame: 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".

    Time frame: Baseline

07

Study locations

1 site
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Apr 2032, 67 months later.

Of 41 non-industry interventional studies with no phase under Femoracetabular Impingement, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 79. This study's planned 67 months is above that.

Counting every sponsor, half of 42 studies reached it within 41 months; a quarter within 28 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2026
First posted
Feb 20, 2026
StartEst.
Sep 2026
Primary completionEst.
Apr 2032
CompletionEst.
Apr 2032
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07422662
Responsible party
Sponsor
First posted
Feb 20, 2026
Start date
Sep 2026 (estimated)
Primary completion
Apr 2032 (estimated)
Completion
Apr 2032 (estimated)
Last update
Jul 1, 2026

Study contacts

Enrico Tassinari, MD
Contact
enrico.tassinari@ior.it
0516366122
Roberta Licciardi, MSc
Contact
roberta.licciardi@ior.it
0516366567
Enrico Tassinari, MD
principal investigator · IRCCS Istituto Ortopedico Rizzoli

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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