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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • BMAC

    Biological/Vaccine

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: BMAC Application1 intervention
Group B: No BMAC Application0 interventions

Trial outcomes

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

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

Secondary outcomes

1

Change HOS Surveys from preoperative to various postoperative timepoints

Full Name of Outcome: HOS--Hip Outcome Score, which consists of two subscores: Hip Outcome Score-Activity of Daily Living (HOS-ADL), Hip Outcome Score-Sports Sub-scale (HOS-SSS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of HOS--ADL: Min: 0 Max: 68 Converted to a percentage, by dividing patient's score by 68. No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. Scale of HOS--SSS: Min: 0 Max: 36 Converted to a percentage, by dividing patient's score by 36. No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally.

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
2

Change NAHS Surveys from preoperative to various postoperative timepoints

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

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

Change LEFS Surveys from preoperative to various postoperative timepoints

Full Name of Outcome: Lower Extremity Functional Scale (LEFS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of LEFS: Min: 0 Max: 80 Converted to a percentage, by dividing patient's score by 80. No standardized scoring categories (i.e. excellent, good, fair, poor). Higher score indicates better hip functionally. No subscores or subscales

Time frame
Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
4

Change mHHS Surveys from preoperative to various postoperative timepoints

Full Name of Outcome: modified Harris Hip Score (mHHS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of mHHS: Min: 0 Max: 100 Scoring of mHHS: Excellent: 90--100 Good: 80--89 Fair: 70--79 Poor: \<70 Higher score indicates better hip functionally. No subscores or subscales.

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

Other outcomes

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