Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear
NCT ID: NCT03909139
Last Updated: 2025-10-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
400 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-09-06
Study Completion Date
2027-06-30
Brief Summary
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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.
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.
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Detailed Description
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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 prospective study which will enroll 400 adult subjects with evidence of an acetabular labrum tear and pincer or cam 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, and cam deformity is diagnosed with antero-posterior and lateral radiographs.
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 using a 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. Subjects will follow-up at routine post-operative intervals of 3 months, 6 months, 12 months, and annually thereafter to monitor progress.
Interval Results:
Martin SD, Kucharik MP, Abraham PF, Nazal MR, Meek WM, Varady NH. Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate \[published online ahead of print, 2021 Oct 14\]. J Bone Joint Surg Am. 2021;10.2106/JBJS.20.01740. doi:10.2106/JBJS.20.01740
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 prospective study which will enroll 400 adult subjects with evidence of an acetabular labrum tear and pincer or cam 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, and cam deformity is diagnosed with antero-posterior and lateral radiographs.
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 using a 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. Subjects will follow-up at routine post-operative intervals of 3 months, 6 months, 12 months, and annually thereafter to monitor progress.
Interval Results:
Martin SD, Kucharik MP, Abraham PF, Nazal MR, Meek WM, Varady NH. Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate \[published online ahead of print, 2021 Oct 14\]. J Bone Joint Surg Am. 2021;10.2106/JBJS.20.01740. doi:10.2106/JBJS.20.01740
Conditions
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Acetabular Labrum Tear
Femoro Acetabular Impingement
Chondral Defect
Bone Marrow Aspirate Concentrate
Mesenchymal Stromal Cell
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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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.
BMAC
Intervention Type
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.
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.
No interventions assigned to this group
Interventions
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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.
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
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
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
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Massachusetts General Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Scott D Martin
Principal Investigator, Director, Joint Preservation Service, Director, MGH Sports Medicine Fellowship
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Scott D Martin, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH, Massachusetts General Hospital
Boston, Massachusetts, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2019P002191
Identifier Type: -
Identifier Source: org_study_id
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WITHDRAWN
PHASE2/PHASE3
Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
NCT06893302
RECRUITING
NA
Conventional Platelet-Rich Plasma Versus Concentrated Bone Marrow Stem Cell Injections for Osteoarthritis of the Knee
NCT03271229
WITHDRAWN
PHASE2
Degenerative Meniscus Without Osteoarthritis : Arthroscopic Partial Menisectomy Versus Platelet Rich Plasma (APM-PRP)
NCT04972331
UNKNOWN
NA
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?
NCT05652881
RECRUITING
NA
A Comparison of PRP Treatment to the IA vs. IA and EA Environments in Patients Diagnosed With Hip Osteoarthritis
NCT04241354
UNKNOWN
PHASE1
Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction
NCT04205656
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Subchondroplasty® Knee RCT
NCT03112200
COMPLETED
NA
Use of Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis
NCT01931007
COMPLETED
PHASE1
Autologous Osteoblastic Cells Implantation to Early Stage Osteonecrosis of the Femoral Head
NCT02890537
COMPLETED
PHASE2
Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
NCT02582489
RECRUITING
NA
Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions
NCT01621893
COMPLETED
MDR - Longevity IT Oblique and Offset Liners
NCT05980234
TERMINATED
Subchondroplasty Procedure in Patients With Bone Marrow Lesions
NCT03430219
COMPLETED
Medial Collateral Ligament Reconstruction With Anteromedial Reinforcement for Medial and Anteromedial Rotatory Knee Instability
NCT05489627
RECRUITING
NA
Platelet-rich Plasma Versus Corticosteroid Injection for the Treatment of Femoroacetabular Impingement
NCT02920177
TERMINATED
PHASE4
A Clinical Investigation of the M2a- 38™ Hip System
NCT00698503
TERMINATED
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
NCT05497349
RECRUITING
NA
MPFLR With Fascia Lata Allograft, Based on Isometry Assessment + Elmslie-Trillat TTO
NCT05868434
RECRUITING
NA
Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty
NCT06792539
RECRUITING
NA
Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Faction (SVF) for Treatment of Osteoarthritis of the Knee
NCT03940950
COMPLETED
PHASE1
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
NCT05400798
ENROLLING_BY_INVITATION
NA
Durom(R) Hip Resurfacing System Multicenter Trial
NCT00746616
COMPLETED
PHASE3
A Study of REcycled CartiLage Auto/Allo IMplantation to Treat and Repair Focal Hip Cartilage Defects
NCT05553132
ACTIVE_NOT_RECRUITING
PHASE1
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
NCT03588975
RECRUITING
PHASE3