Recruiting

BMAC with Hip Arthroscopy

Sponsor:

Massachusetts General Hospital

Code:

NCT03909139

Conditions

Acetabular Labrum Tear

Femoro Acetabular Impingement

Chondral Defect

Bone Marrow Aspirate Concentrate

Mesenchymal Stromal Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMAC

Study Details

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

Study ID

NCT03909139

Start date

Sep 6, 2019

Status verified date

Oct, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria and Rationale:

1. Age 18 or older: patients of any age have the capacity to potentially benefit from labral repair
2. 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.
3. 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.
4. Availability of hip radiographs and magnetic resonance imaging (MRI and/or MRA): needed to assess eligibility
5. Evidence of labral tear on MRI and/or MRA: documentation of acetabular labrum tear
6. Willingness to participate and ability to understand and sign informed consent document: ability to understand study and consent willingly
7. Returning subjects enrolled in protocol 2017P001391/PHS

Exclusion Criteria and Rationale:

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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

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.

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 and Locations

Central contacts

Scott D Martin, MD

617-732-5329sdmartin@partners.org

Locations

MGH, Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Scott D Martin, MD

617-643-0886SDMARTIN@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 27, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-27.