Acetabular Labrum TearNCT03909139
Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear
An observational study of Acetabular Labrum Tear and Femoro Acetabular Impingement, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Labrum Tear, Femoro Acetabular Impingement, Chondral Defect
- What is being tested?
- BMAC
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to 30 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study 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.
Who may be able to join
- 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
- Evidence of labral tear on MRI and/or MRA: documentation of acetabular labrum tear
- Willingness to participate and ability to understand and sign informed consent document: ability to understand study and consent willingly
- Returning subjects enrolled in protocol 2017P001391/PHS
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MGH, Massachusetts General Hospital
Boston, Massachusetts, 02114
Scott D Martin, MD, 617-643-0886, SDMARTIN@partners.org
About this study
Official title: Prospective PROMs Outcomes in Arthroscopic Acetabular Labral Repair With and Without Application of Platelet-Rich Plasma (PRP) Harvested From the Body of the Ilium
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.
Read more
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.
Read the 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 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
- Acetabular Labrum Tear, Femoro Acetabular Impingement, Chondral Defect, Bone Marrow Aspirate Concentrate, Mesenchymal Stromal Cell
- Being tested
- BMAC
- Keywords
- Acetabular Labrum Tear, Femoro Acetabular Impingement, Chondral Defect, Bone Marrow Aspirate Concentrate, Mesenchymal Stromal Cell, Chondrolabral Junction, Osteoarthritis, Femoroacetabuloplasty, Hip Arthroscopy, BMAC
- Medical subject headings
- Femoracetabular Impingement, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMACBiological
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: BMAC | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
Secondary outcomes (7)
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
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
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
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.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
Change RAND-36 Surveys from preoperative to various postoperative timepoints
RAND-36 Measure of Health-Related Quality of Life (RAND 36 or SF 36):
The most widely used health-related quality-of-life survey instrument
Consists of 36 questions that assess eight components of health: physical functioning, role limitation due to physical health problems, role limitations due to emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions, with a simple mean of these responses ranging from 0 to 100, with 100 representing the best possible quality-of-life score.
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
Degree of Improvement on Hip VAS Pain Score
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
Measured: Baseline (pre-operative), 3 months, 6 months, 12 months, and annually thereafter
Patient Satisfaction Questionnaires
Three Yes/No Questions:
- Are you satisfied with the treatment you received?
- Are you satisfied with the treatment regimen that you were given?
- If given the choice in the future, would you choose the same treatment?
Measured: 12 months and annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start6 Sep 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Acetabular Labrum TearStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott D Martin, Massachusetts General Hospital
- Investigators
- Scott D Martin, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909139
- Sponsor's protocol ID
- 2019P002191
- Status last verified
- Oct 2025
- First submitted
- 11 Jun 2018
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cotten A, Boutry N, Demondion X, Paret C, Dewatre F, Liesse A, Chastanet P, Fontaine C. Acetabular labrum: MRI in asymptomatic volunteers. J Comput Assist Tomogr. 1998 Jan-Feb;22(1):1-7. doi: 10.1097/00004728-199801000-00001.
PubMed 9448753Register B, Pennock AT, Ho CP, Strickland CD, Lawand A, Philippon MJ. Prevalence of abnormal hip findings in asymptomatic participants: a prospective, blinded study. Am J Sports Med. 2012 Dec;40(12):2720-4. doi: 10.1177/0363546512462124. Epub 2012 Oct 25.
PubMed 23104610Ganz R, Parvizi J, Beck M, Leunig M, Notzli H, Siebenrock KA. Femoroacetabular impingement: a cause for osteoarthritis of the hip. Clin Orthop Relat Res. 2003 Dec;(417):112-20. doi: 10.1097/01.blo.0000096804.78689.c2.
PubMed 14646708Field RE, Rajakulendran K. The labro-acetabular complex. J Bone Joint Surg Am. 2011 May;93 Suppl 2:22-7. doi: 10.2106/JBJS.J.01710.
PubMed 21543684Song Y, Ito H, Kourtis L, Safran MR, Carter DR, Giori NJ. Articular cartilage friction increases in hip joints after the removal of acetabular labrum. J Biomech. 2012 Feb 2;45(3):524-30. doi: 10.1016/j.jbiomech.2011.11.044. Epub 2011 Dec 15.
PubMed 22176711Byrd JW. The role of hip arthroscopy in the athletic hip. Clin Sports Med. 2006 Apr;25(2):255-78, viii. doi: 10.1016/j.csm.2005.12.007.
PubMed 16638490Khanduja V, Villar RN. Arthroscopic surgery of the hip: current concepts and recent advances. J Bone Joint Surg Br. 2006 Dec;88(12):1557-66. doi: 10.1302/0301-620X.88B12.18584.
PubMed 17159164Kelly BT, Weiland DE, Schenker ML, Philippon MJ. Arthroscopic labral repair in the hip: surgical technique and review of the literature. Arthroscopy. 2005 Dec;21(12):1496-504. doi: 10.1016/j.arthro.2005.08.013.
PubMed 16376242Montgomery SR, Ngo SS, Hobson T, Nguyen S, Alluri R, Wang JC, Hame SL. Trends and demographics in hip arthroscopy in the United States. Arthroscopy. 2013 Apr;29(4):661-5. doi: 10.1016/j.arthro.2012.11.005. Epub 2013 Feb 1.
PubMed 23375668Fry R, Domb B. Labral base refixation in the hip: rationale and technique for an anatomic approach to labral repair. Arthroscopy. 2010 Sep;26(9 Suppl):S81-9. doi: 10.1016/j.arthro.2010.01.021. Epub 2010 Jul 7.
PubMed 20615651Lubowitz JH, Poehling GG. Watch your footprint: anatomic ACL reconstruction. Arthroscopy. 2009 Oct;25(10):1059-60. doi: 10.1016/j.arthro.2009.08.001. No abstract available.
PubMed 19801278Audenaert EA, Dhollander AA, Forsyth RG, Corten K, Verbruggen G, Pattyn C. Histologic assessment of acetabular labrum healing. Arthroscopy. 2012 Dec;28(12):1784-9. doi: 10.1016/j.arthro.2012.06.012. Epub 2012 Oct 17.
PubMed 23084152Philippon MJ, Arnoczky SP, Torrie A. Arthroscopic repair of the acetabular labrum: a histologic assessment of healing in an ovine model. Arthroscopy. 2007 Apr;23(4):376-80. doi: 10.1016/j.arthro.2007.01.017.
PubMed 17418329Petersen W, Petersen F, Tillmann B. Structure and vascularization of the acetabular labrum with regard to the pathogenesis and healing of labral lesions. Arch Orthop Trauma Surg. 2003 Jul;123(6):283-8. doi: 10.1007/s00402-003-0527-7. Epub 2003 Jun 7.
PubMed 12802599Syed HM, Martin SD. Arthroscopic acetabular recession with chondrolabral preservation. Am J Orthop (Belle Mead NJ). 2013 Apr;42(4):181-4.
PubMed 23630678