Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear

NCT03909139 | Recruiting FDA Drug

• 1 other identifier: 2019P002191
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Femoro-acetabular impingement is a well known cause of damage to the acetabular labrum and chondrolabral junction. Additionally, it has been proposed that disruption of hip biomechanics resulting from a labral tear causes a faster progression towards osteoarthritis (OA). This progression has been observed to begin with breakdown of the chondrolabral junction with later development of diffuse osteoarthritis. Use of hip arthroscopy has increased dramatically in recent years to treat symptomatic labral tears and potentially avoid the morbidity and cost associated with hip osteoarthritis. Correction of labral pathology presents a technical challenge and many techniques currently exist. Increased understanding of the structure-functional relationship dictated by labral anatomy has led to the development of methods aimed at restoring functional anatomy by re-establishing the labrum's native position and contour on the rim of the acetabulum. Therefore, akin to repairing a torn meniscus in the knee, restoring the anatomic footprint of a torn labrum will reconstitute normal joint biomechanics. Despite the advances in techniques for labral repair, strategies for mitigating or repairing damage to the chondrolabral junction do not yet exist. This area has been shown to consist of hyaline and fibro cartilage. Many techniques for cartilage repair exist, although most are not feasible due to technical challenges specific to the hip joint. The management of articular cartilage defects is one of the most challenging clinical problems for orthopaedic surgeons. Articular cartilage has a limited intrinsic healing capacity, and pathology frequently results in gradual tissue deterioration. Currently, the standard surgical intervention for end-stage degenerative joint pathology is total joint replacement. Early surgical interventions for symptomatic cartilage lesions including cell based therapies such as autologous chondrocyte implantation (ACI), bone marrow aspirate concentrate (BMAC) implantation, or microfracture have been suggested to restore normal joint congruity and minimize further joint deterioration. Techniques such as ACI, which have been successfully used in the knee joint, have limited application in the hip due to the technical difficulties of open procedures.

Conditions

Acetabular Labrum Tear; Femoro Acetabular Impingement; Chondral Defect; Bone Marrow Aspirate Concentrate; Mesenchymal Stromal Cell

Keywords

Acetabular Labrum Tear; Femoro Acetabular Impingement; Chondral Defect; Bone Marrow Aspirate Concentrate; Mesenchymal Stromal Cell; Chondrolabral Junction; Osteoarthritis; Femoroacetabuloplasty; Hip Arthroscopy; BMAC

Outcome Measures

Primary Outcomes (1)

• Change iHOT--33 Surveys from preoperative to various postoperative timepoints

  Full Name of Outcome: International Hip Outcome Tool--33 Questions Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of iHOT-33: Min: 0 Max: 100 No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. No subscores or subscales

  Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter

Secondary Outcomes (7)

• Change HOS Surveys from preoperative to various postoperative timepoints

  Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter

• Change NAHS Surveys from preoperative to various postoperative timepoints

  Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter

• Change LEFS Surveys from preoperative to various postoperative timepoints

  Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter

• Change mHHS Surveys from preoperative to various postoperative timepoints

  Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter

• Change RAND-36 Surveys from preoperative to various postoperative timepoints

  Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter

Study Arms (2)

BMAC Application

Patients age 18 or older with evidence consistent with a tear of the acetabular labrum and breakdown of the chondrolabral junction and consent to arthroscopic labral tear repair. BMAC application at the time of arthroscopic labral repair.

Biological: BMAC

No BMAC Application

Patients age 18 or older with evidence consistent with a tear of the acetabular labrum and breakdown of the chondrolabral junction and consent to arthroscopic labral tear repair. No BMAC application at the time of arthroscopic labral repair.

Interventions

BMAC BIOLOGICAL

A bone marrow biopsy needle will be inserted through an arthroscopy portal and directed to the acetabuloplasty site. Bone marrow is aspirated then centrifuged. From the centrifuged sample, the buffy coat layer (layer of cells, found between the red blood cells and the plasma layers) is removed. The buffy coat layer contains mesenchymal stromal cells. This is called BMAC or Bone Marrow Aspirate Concentrate. The BMAC will be injected into the intra-articular space.

BMAC Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective study which will enroll adult subjects with evidence of an acetabular labrum tear. These subjects will be enrolled consecutively using the aforementioned criteria until we hit our enrollment of 300 subjects.

You may qualify if:

• Age 18 or older: patients of any age have the capacity to potentially benefit from labral repair
• Symptoms consistent with a tear of the acetabular labrum (i.e., catching, clicking, popping, pain with sitting, episodic pain, pain with hip flexion, adduction, and/or internal rotation): asymptomatic labral tears do exist in the general population however there is not definitive evidence to suggest treatment of asymptomatic tears is beneficial.
• Symptoms not due to some other acute process in or around the hip (including septic arthritis, osteonecrosis, hemarthrosis, iliotibial band syndrome, fractures of the femoral neck or head, fractures of the acetabulum, greater trochanteric pain syndrome, sacroiliac joint pain, piriformis syndrome, low back pain associated with hip pain and not knee nor acute low back injury): certain conditions are not treatable by either arthroscopy or physical therapy. Some of these conditions can be managed with physical therapy but not arthroscopy.
• Availability of hip radiographs and magnetic resonance imaging (MRI and/or MRA): needed to assess eligibility
• Evidence of labral tear on MRI and/or MRA: documentation of acetabular labrum tear
• Willingness to participate and ability to understand and sign informed consent document: ability to understand study and consent willingly
• Returning subjects enrolled in protocol 2017P001391/PHS

You may not qualify if:

• Non-English speaking subjects: PROMs are only validated in English.
• Systemic infection: surgery is generally contraindicated when systemic infection is present.
• Systemic heparinization: the vascularity of the bone and adjacent tissues is significant, posing a potential problem for bleeding when the patient is anti-coagulated.
• Pregnant women/fetuses: although surgery can be performed on pregnant women, pregnant women are excluded under federal regulations.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

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Biospecimen

Retention: NONE RETAINED

Bone marrow is aspirated then centrifuged. From the centrifuged sample, the buffy coat layer (layer of cells, found between the red blood cells and the plasma layers) is removed. The buffy coat layer contains mesenchymal stromal cells. This sample of centrifuged, concentrated mesenchymal stromal cells is called BMAC or Bone Marrow Aspirate Concentrate. The BMAC will be injected into the intra-articular space.

MeSH Terms

Conditions

Femoracetabular Impingement; Osteoarthritis

Condition Hierarchy (Ancestors)

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

Study Officials

• Scott D Martin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott D Martin, MD

CONTACT

617-732-5329; sdmartin@partners.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director, Joint Preservation Service, Director, MGH Sports Medicine Fellowship

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: April 9, 2019
• Study Start: September 6, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)