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

February 20, 2026 updated by: Istituto Ortopedico Rizzoli

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hip arthroscopy + BMAC injection
Arthroscopic procedure with the addition of intra-articular bone marrow infiltration
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).
Active Comparator: Hip arthroscopy
Exclusively arthroscopic treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 24 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time Frame: 1-3-6-12 months

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)
1-3-6-12 months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 1-3-6-12- 24 months
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
1-3-6-12- 24 months
Harris Hip Scale (HHS)
Time Frame: 1-3-6-12- 24 months
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.
1-3-6-12- 24 months
Overall assessment of the treatment
Time Frame: 1-3-6-12- 24 months
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"
1-3-6-12- 24 months
Expectations of treatment efficacy
Time Frame: Baseline
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".
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Enrico Tassinari, MD, IRCCS Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BoneMarrowHip

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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