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BMAC Use With Labral Repair

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ClinicalTrials.gov Identifier: NCT03909139
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Scott D Martin, Massachusetts General Hospital

Brief Summary:

Introduction:

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.


Condition or disease Intervention/treatment
Acetabular Labrum Tear Pincer Lesion Femoro Acetabular Impingement Chondral Defect Bone Marrow Aspirate Concentrate Mesenchymal Stem Cell Biological: BMAC

Detailed Description:

The acetabular labrum is a wedge shaped fibrocartilage structure attached to the acetabular rim. It is continuous with the transverse acetabular ligament at the inferior aspect of the acetabulum. The medial aspect of the labrum abuts the acetabulum to form the chondrolabral junction.

Anatomic labral refixation aims to preserve healthy tissue and restore native joint anatomy and biomechanics. Labral tears that are caused by Femoro-Acetubular Impingement (FAI) require concomitant correction of bony cam lesions, pincer lesions, or both to prevent reinjury of the labrum. However, repair has not yet been proven to mitigate the osteoarthritic accelerating effects of labral tears. Many patients presenting with hip pain in the third and fourth decade of life already have osteoarthritic changes seen at the time of arthroscopy. Restoring the biomechanics of the joint via labral repair does not reverse this damage and investigating methods to repair early osteoarthritis is important to the future of hip arthroscopy.

Bone marrow aspirate concentrate (BMAC) has been used effectively in many joints for the management of chondral defect repair. As an alternative to the aforementioned chondral treatment modalities, BMAC treatment does not require multiple procedures or additional waiting time for treatment completion.

Within the technical constraints of the hip joint, bone marrow aspirate concentrate is feasible and potentially efficacious option for the treatment of chondral defects. Late stage hip osteoarthritis is a known factor implicated in poor outcomes in both the surgical and non-surgical treatment options available for chondral defect management. Preventing late stage hip osteoarthritis is paramount to decrease these poor outcomes and improve the patient's quality of life. Early and effective intervention with modalities that afford patients little to no drawbacks, like BMAC treatment, are necessary to achieve these goals.

This is a 24-month prospective study, which will enroll 40 adult subjects with evidence of an acetabular labrum tear and pincer deformity. Labral tears will be diagnosed by clinical exam and positive magnetic resonance arthrogram (MRA) findings. Pincer deformity is diagnosed with standard antero-posterior radiographs of the pelvis.

Administration of diagnostic modalities is independent of study protocol as they are routine standard of care. Upon diagnosis, eligible potential subjects will be approached for study enrollment. After consent, enrolled subjects will undergo arthroscopic labral repair and acetabuloplasty using the capsular chondrolabral preservation technique with or without BMAC based on intra-operative findings. The decision to use BMAC is made intra-operatively; therefore the patients are consented for the BMAC prior to surgery. If the chondrolabral junction shows advanced arthritis or the absolute absence of wear the BMAC is unnecessary and not used. This surgery in the absence of BMAC is considered routine practice and standard of care. Those patients who do not qualify for BMAC will not receive it and will be dropped from the study. Afterwards, those subjects who received BMAC will follow-up at routine post-operative intervals of 3 months, 6 months, 12 months, 24 months, and an optional follow-up at 5 years to monitor progress.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mesenchymal Stem Cell Use With Labral Repair to Manage Chondrolabral Junction Breakdown
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Group/Cohort Intervention/treatment
All Patients
40 patients age 18 or older with evidence consistent with a tear of the acetabular labrum and breakdown of the chondrolabral junction and consent to a arthroscopic labral tear repair.
Biological: 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 stem cells. This is called BMAC or Bone Marrow Aspirate Concentrate. Around 1mL of the BMAC sample is placed into cryo-vials for cell count analysis, where the number of different types of stem cells are counted. The remainder of the BMAC will be injected into the intra-articular space.




Primary Outcome Measures :
  1. Change in mHHS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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.



Secondary Outcome Measures :
  1. Progression of arthritis [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]
    Patients will receive Plain radiographs of the hip joint, these radiographs are already a component of the standard of care. The treatment team will monitor these radiographs for changes of the present and amount of arthritis.

  2. Change HOS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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.


  3. Change NAHS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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.


  4. Change iHOT--33 Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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


  5. Change LEFS Surveys from preoperative to various postoperative timepoints [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    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


  6. Patient Satisfaction Questionnaires [ Time Frame: 12 months and 24 months ]

    Three Yes/No Questions:

    1. Are you satisfied with the treatment you received?
    2. Are you satisfied with the treatment regimen that you were given?
    3. If given the choice in the future, would you choose the same treatment?

  7. Degree of Improvement on Hip Strength [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    At routine follow-up visits patients have a routine physical exam that will measure hip strength.

    Muscle Strength Testing is done using the resisted muscular contraction (RMC) scale:

    0—no muscle firing

    hip muscle contraction, no joint movement hip movement with gravity eliminated hip movement against gravity, but not against resistance hip movement against resistance, but not full strength full strength


  8. Degree of Improvement on Hip Range of Motion (ROM) [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    At routine follow-up visits patients have a routine physical exam that will measure hip range of motion (ROM). ROM is measured in degrees.

    For reference:

    A right angle is 90 degrees. A straight line is 180 degrees.


  9. Degree of Improvement on Hip VAS Pain Score [ Time Frame: Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months ]

    At routine follow-up visits patients will be asked to rate hip pain using the VAS (Visual Analog Scale) Score

    Min: 0--no pain Max: 10--worst pain experienced in their life

    Increments of 1.

    Categories:

    1--3: mild pain 4--6: moderate pain 7--10: severe pain



Biospecimen Retention:   Samples With DNA

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 stem cells.

This sample of centrifuged, concentrated stem cells is called BMAC or Bone Marrow Aspirate Concentrate. Around 1mL of the BMAC sample is placed into cryo-vials for cell count analysis, where the number of different types of stem cells are counted.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
This is a 24-month prospective study, which will enroll 40 adult subjects with evidence of an acetabular labrum tear. These 40 subjects will be enrolled consecutively using the aforementioned criteria.
Criteria

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 (at least one: 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 arthrography (MRA): needed to assess eligibility
  5. Evidence of labral tear on MRA: documentation of acetabular labrum tear
  6. Evidence of femoroacetabular impingement, pincer type, on anteroposterior radiographs of the pelvis or MRA: patho-anatomy required to perform acetabuloplasty with capsular chondrolabral preservation; documentation needed to prove eligibility for study; pincer deformity is suspected by "cross-over" sign, reflective of acetabular retroversion, on standard antero-posterior radiographs.
  7. Willingness to participate and ability to understand and sign informed consent document: ability to understand study and consent willingly
  8. Presence of breakdown at the chondrolabral junction visualized at the time of arthroscopy: patients without any chondral damage or patients with advanced arthritis would not require repair of this area

Exclusion criteria and Rationale:

  1. Any narrowing of the joint space of the affected hip on standing plain anterior-posterior radiographs of the hip: indicative of osteoarthritic disease that may confound our results.
  2. Coagulopathy or hemophilia or anemia: abnormal bleeding patterns skew the normal rate of labral blood flow. Confounder of results.
  3. Tonnis Grade 3 Arthritic changes on plain radiographs: these patients have advanced arthritic disease that is unlikely to benefit from hip arthroscopy.
  4. Outerbridge Grade 4 arthritic changes at arthroscopy: classified as visualized full thickness cartilage loss with exposure of subchondral bone. These patients have advanced arthritic disease that is unlikely to benefit from BMAC intervention. These patients would likely negatively skew results at long term follow-up
  5. Same site surgery: complex anatomy
  6. Back pain greater than hip pain or back pain associated with leg symptoms below the knee: source of pain less likely to be originating from the hip and more likely to be referred from the back/spine. Confounder of results.
  7. Back pain associated with positive neural tension signs e.g. positive slump test, positive SLR (straight leg raise), positive reflex changes or drop foot: source of pain less likely to be originating from the hip and more likely to be referred from the back/spine. Confounder of results.
  8. Knee pain greater than hip pain: source of pain less likely to be originating from the hip and more likely to referred from the knee. Confounder of results.
  9. Bilateral tears of the acetabular labrum: difficult to gauge patient progress after treatment. Confounder of results.
  10. Metabolic or oncologic medical history that may affect the status of bone marrow cell lines: cells exposed to oncologic diseases, metabolic diseases, or treatments of these conditions may not have the same regenerative potential as those without these exposures.
  11. Systemic infection: surgery is generally contraindicated when systemic infection is present.

12: Systemic heparinization: the vascularity of the bone and adjacent tissues is significant, posing a potential problem for bleeding when the patient is anti-coagulated.

13. Pregnant women/fetuses: although surgery can be performed on pregnant women, pregnant women are excluded under federal regulations.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909139


Contacts
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Contact: Scott D Martin, MD 617-732-5329 sdmartin@partners.org
Contact: Mark R Nazal, MPH 617-643-0886 mnazal@mgh.harvard.edu

Locations
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United States, Massachusetts
MGH, Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mark R Nazal, MPH    617-643-0886    mnazal@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Scott D Martin, MD Massachusetts General Hospital

Publications:
Perimed. Laser Doppler Probes. Perimed AB. Web. 25 Aug. 2013.
Swiontkowski MF, Iannotti JP, Boulas HJ, Esterhai JL. Intraoperative assessment of rotator cuff vascularity using laser doppler flowmetry. In: Post M, Morr, eds. Surgery of the shoulder. St. Louis: Mosby, 1990: 208-12.

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Responsible Party: Scott D Martin, Principal Investigator, Director, Joint Preservation Service, Director, MGH Sports Medicine Fellowship, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03909139     History of Changes
Other Study ID Numbers: 2017P001391/PHS
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Scott D Martin, Massachusetts General Hospital:
Mesenchymal Stem Cell
Bone Marrow Cell Analysis
Acetabular Labrum Tear
Pincer Lesion
Femoro Acetabular Impingement
Chondral Defect
Bone Marrow Aspirate Concentrate
Chondrolabral Junction
Osteoarthritis
Acetabuloplasty
Hip Arthroscopy
BMAC

Additional relevant MeSH terms:
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Femoracetabular Impingement
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes