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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03909139
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Sep 6, 2019
Status verified
Oct 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Change iHOT--33 Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MGH, Massachusetts General HospitalBostonMassachusetts02114
Scott D Martin, MD
[email protected]
617-643-0886

Find similar trials in Boston, MA

By research site
MGH, Massachusetts General Hospital· Boston, MA

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