Intraoperative Bone Marrow Aspirate Concentrate Injections: Evaluating Outcomes in a Randomized Controlled Trial

Summary

The purpose of this study is to see if bone marrow aspirate concentrate (BMAC) used with your hip arthroscopy surgery is a better treatment than just having surgery alone for treatment of labral tears in your hip. BMAC is an injection, where your doctor will insert a needle into your hip and harvest the bone marrow that is located inside of your bones. This will be performed under anesthesia during your hip arthroscopy surgery and will be injected during the procedure. BMAC is an FDA approved procedure and has had many research articles produced from it. Researchers will compare patients who received BMAC during their surgery to those who have not to determine if the injection with surgery is better than surgery alone.

Timeline

Start

2025-02

Primary completion

2027-02

Completion

2028-02

Publications

• Background Chan JJ, Vogel MJ, Larson JH, Nho SJ. Cartilage Defects Are Negatively Associated With Long-Term Hip Survivorship Following Contemporary Hip Arthroscopy for Femoroacetabular Impingement Syndrome: A Propensity-Matched Analysis at Minimum 10-Year Follow-Up. Arthroscopy. 2024 Nov;40(11):2681-2692. doi: 10.1016/j.arthro.2024.01.040. Epub 2024 Feb 7.
• Background MacDonald AE, Bedi A, Horner NS, de Sa D, Simunovic N, Philippon MJ, Ayeni OR. Indications and Outcomes for Microfracture as an Adjunct to Hip Arthroscopy for Treatment of Chondral Defects in Patients With Femoroacetabular Impingement: A Systematic Review. Arthroscopy. 2016 Jan;32(1):190-200.e2. doi: 10.1016/j.arthro.2015.06.041. Epub 2015 Sep 15.
• Background George T, Curley AJ, Saeed SK, Kuhns BD, Parsa A, Domb BG. Orthobiologics as an adjunct in treatment of femoroacetabular impingement syndrome: cell-based therapies facilitate improved postoperative outcomes in the setting of acetabular chondral lesions-a systematic review. Knee Surg Sports Traumatol Arthrosc. 2023 Dec;31(12):6020-6038. doi: 10.1007/s00167-023-07624-4. Epub 2023 Oct 31.
• Background Siddiq BS, Giorgino R, Gillinov SM, Lee JS, Dowley KS, Cherian NJ, Martin SD. Neither Bone Marrow Aspirate Concentrate nor Platelet-Rich Plasma Improves Patient-Reported Outcomes After Surgical Management of Acetabular Labral Tears; However, Bone Marrow Aspirate Concentrate May Be Effective for Moderate Cartilage Damage: A Systematic Review. Arthrosc Sports Med Rehabil. 2024 Aug 28;6(6):100991. doi: 10.1016/j.asmr.2024.100991. eCollection 2024 Dec.
• Background Kucharik MP, Abraham PF, Nazal MR, Varady NH, Eberlin CT, Meek WM, Naessig SA, Martin SD. Treatment of Full-Thickness Acetabular Chondral Flaps During Hip Arthroscopy: Bone Marrow Aspirate Concentrate Versus Microfracture. Orthop J Sports Med. 2021 Dec 7;9(12):23259671211059170. doi: 10.1177/23259671211059170. eCollection 2021 Dec.
• Background Bodendorfer BM, DeFroda SF, Clapp IM, Newhouse A, Nwachukwu BU, Nho SJ. Defining Clinically Significant Improvement on the Patient-Reported Outcomes Measurement Information System Test at 1-Year Follow-up for Patients Undergoing Hip Arthroscopy for the Treatment of Femoroacetabular Impingement Syndrome. Am J Sports Med. 2021 Jul;49(9):2457-2465. doi: 10.1177/03635465211015687. Epub 2021 Jun 7.
• Background Frane JW. A Method of Biased Coin Randomization, Its Implementation, and Its Validation. Drug Inf J : DIJ Drug Inf Assoc 1998;32:423-32. https://doi.org/10.1177/009286159803200213.
• Background Li X, Zhou J, Hu F. Testing hypotheses under adaptive randomization with continuous covariates in clinical trials. Stat Methods Med Res. 2019 Jun;28(6):1609-1621. doi: 10.1177/0962280218770231. Epub 2018 May 17.
• Background Lee S, Nardo L, Kumar D, Wyatt CR, Souza RB, Lynch J, McCulloch CE, Majumdar S, Lane NE, Link TM. Scoring hip osteoarthritis with MRI (SHOMRI): A whole joint osteoarthritis evaluation system. J Magn Reson Imaging. 2015 Jun;41(6):1549-57. doi: 10.1002/jmri.24722. Epub 2014 Aug 20.
• Background Grace T, Neumann J, Samaan MA, Souza RB, Majumdar S, Link TM, Zhang AL. Using the Scoring Hip Osteoarthritis with Magnetic Resonance Imaging (SHOMRI) system to assess intra-articular pathology in femoroacetabular impingement. J Orthop Res. 2018 Nov;36(11):3064-3070. doi: 10.1002/jor.24102. Epub 2018 Jul 13.
• Background Neumann J, Zhang AL, Schwaiger BJ, Samaan MA, Souza R, Foreman SC, Joseph GB, Grace T, Majumdar S, Link TM. Validation of scoring hip osteoarthritis with MRI (SHOMRI) scores using hip arthroscopy as a standard of reference. Eur Radiol. 2019 Feb;29(2):578-587. doi: 10.1007/s00330-018-5623-8. Epub 2018 Jul 9.
• Background Heerey JJ, Souza RB, Link TM, Luitjens J, Gassert F, Kemp JL, Scholes MJ, Crossley KM. Defining hip osteoarthritis feature prevalence, severity, and change using the Scoring of Hip Osteoarthritis with MRI (SHOMRI). Skeletal Radiol. 2024 Aug;53(8):1599-1609. doi: 10.1007/s00256-024-04628-0. Epub 2024 Mar 9.
• Background Schwaiger BJ, Gersing AS, Lee S, Nardo L, Samaan MA, Souza RB, Link TM, Majumdar S. Longitudinal assessment of MRI in hip osteoarthritis using SHOMRI and correlation with clinical progression. Semin Arthritis Rheum. 2016 Jun;45(6):648-55. doi: 10.1016/j.semarthrit.2016.04.001. Epub 2016 Apr 8.
• Background Maldonado DR, Rosinsky PJ, Shapira J, Domb BG. Stepwise Safe Access in Hip Arthroscopy in the Supine Position: Tips and Pearls From A to Z. J Am Acad Orthop Surg. 2020 Aug 15;28(16):651-659. doi: 10.5435/JAAOS-D-19-00856.
• Background Seldes RM, Tan V, Hunt J, Katz M, Winiarsky R, Fitzgerald RH Jr. Anatomy, histologic features, and vascularity of the adult acetabular labrum. Clin Orthop Relat Res. 2001 Jan;(382):232-40. doi: 10.1097/00003086-200101000-00031.
• Background Outerbridge RE. The etiology of chondromalacia patellae. 1961. Clin Orthop Relat Res. 2001 Aug;(389):5-8. doi: 10.1097/00003086-200108000-00002. No abstract available.
• Background Botser IB, Martin DE, Stout CE, Domb BG. Tears of the ligamentum teres: prevalence in hip arthroscopy using 2 classification systems. Am J Sports Med. 2011 Jul;39 Suppl:117S-25S. doi: 10.1177/0363546511413865.
• Background Domb BG, Sgroi TA, VanDevender JC. Physical Therapy Protocol After Hip Arthroscopy: Clinical Guidelines Supported by 2-Year Outcomes. Sports Health. 2016 Jul;8(4):347-54. doi: 10.1177/1941738116647920. Epub 2016 May 12.
• Background Chahal J, Van Thiel GS, Mather RC 3rd, Lee S, Song SH, Davis AM, Salata M, Nho SJ. The Patient Acceptable Symptomatic State for the Modified Harris Hip Score and Hip Outcome Score Among Patients Undergoing Surgical Treatment for Femoroacetabular Impingement. Am J Sports Med. 2015 Aug;43(8):1844-9. doi: 10.1177/0363546515587739. Epub 2015 Jun 15.
• Background Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, Bombardier C, Felson D, Hochberg M, van der Heijde D, Dougados M. Evaluation of clinically relevant states in patient reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis. 2005 Jan;64(1):34-7. doi: 10.1136/ard.2004.023028. Epub 2004 May 6.
• Background Zusmanovich M, Haselman W, Serrano B, Banffy M. The Incidence of Hip Arthroscopy in Patients With Femoroacetabular Impingement Syndrome and Labral Pathology Increased by 85% Between 2011 and 2018 in the United States. Arthroscopy. 2022 Jan;38(1):82-87. doi: 10.1016/j.arthro.2021.04.049. Epub 2021 May 5.
• Background Griffin DR, Dickenson EJ, O'Donnell J, Agricola R, Awan T, Beck M, Clohisy JC, Dijkstra HP, Falvey E, Gimpel M, Hinman RS, Holmich P, Kassarjian A, Martin HD, Martin R, Mather RC, Philippon MJ, Reiman MP, Takla A, Thorborg K, Walker S, Weir A, Bennell KL. The Warwick Agreement on femoroacetabular impingement syndrome (FAI syndrome): an international consensus statement. Br J Sports Med. 2016 Oct;50(19):1169-76. doi: 10.1136/bjsports-2016-096743.
• Background Ibarra C, Villalobos E, Madrazo-Ibarra A, Velasquillo C, Martinez-Lopez V, Izaguirre A, Olivos-Meza A, Cortes-Gonzalez S, Perez-Jimenez FJ, Vargas-Ramirez A, Franco-Sanchez G, Ibarra-Ibarra LG, Sierra-Suarez L, Almazan A, Ortega-Sanchez C, Trueba C, Martin FB, Arredondo-Valdes R, Chavez-Arias D. Arthroscopic Matrix-Assisted Autologous Chondrocyte Transplantation Versus Microfracture: A 6-Year Follow-up of a Prospective Randomized Trial. Am J Sports Med. 2021 Jul;49(8):2165-2176. doi: 10.1177/03635465211010487. Epub 2021 May 28.
• Background Bretschneider H, Trattnig S, Landgraeber S, Hartmann A, Gunther KP, Dienst M, Schroder J, Fickert S. Arthroscopic matrix-associated, injectable autologous chondrocyte transplantation of the hip: significant improvement in patient-related outcome and good transplant quality in MRI assessment. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1317-1324. doi: 10.1007/s00167-019-05466-7. Epub 2019 Apr 16.
• Background Gebhardt S, Hofer A, Wassilew GI, Sobau C, Zimmerer A. Minced Cartilage Implantation in Acetabular Cartilage Defects: Case Series with 2-Year Results. Cartilage. 2023 Dec;14(4):393-399. doi: 10.1177/19476035231189840. Epub 2023 Aug 3.
• Background Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003 May;41(5):582-92. doi: 10.1097/01.MLR.0000062554.74615.4C.
• Background Stelzer JW, Martin SD. Use of Bone Marrow Aspirate Concentrate with Acetabular Labral Repair for the Management of Chondrolabral Junction Breakdown. Arthrosc Tech. 2018 Sep 1;7(10):e981-e987. doi: 10.1016/j.eats.2018.06.003. eCollection 2018 Oct.
• Background Martin SD, Eberlin CT, Kucharik MP, Cherian NJ. Harvest and Application of Bone Marrow Aspirate Concentrate to Address Acetabular Chondral Damage During Hip Arthroscopy. JBJS Essent Surg Tech. 2023 May 24;13(2):e22.00010. doi: 10.2106/JBJS.ST.22.00010. eCollection 2023 Apr-Jun.
• Background Sullivan SW, Aladesuru OM, Ranawat AS, Nwachukwu BU. The use of biologics to improve patient-reported outcomes in hip preservation. J Hip Preserv Surg. 2021 Apr 17;8(1):3-13. doi: 10.1093/jhps/hnab028. eCollection 2021 Jan.
• Background Hevesi M, Jacob G, Shimomura K, Ando W, Nakamura N, Krych AJ. Current hip cartilage regeneration/repair modalities: a scoping review of biologics and surgery. Int Orthop. 2021 Feb;45(2):319-333. doi: 10.1007/s00264-020-04789-2. Epub 2020 Sep 10.
• Background Jildeh TR, Abbas MJ, Buckley P, Okoroha KR. The Use of Biologics for Hip Preservation. Curr Rev Musculoskelet Med. 2021 Apr;14(2):145-154. doi: 10.1007/s12178-021-09695-7. Epub 2021 Jan 23.
• Background Kim DN, Fong S, Park N, Simington J, Atadja L, Pettinelli N, Lee MS, Gillinov SM, Maldonado DR, Jimenez AE. Mid- to Long-Term Outcomes in Patients After Hip Arthroscopy With Labral Reconstruction: A Systematic Review. Orthop J Sports Med. 2024 Jun 1;12(6):23259671241232306. doi: 10.1177/23259671241232306. eCollection 2024 Jun.
• Background Philippon MJ, Arner JW, Crawford MD, Bolia IK, Briggs KK. Acetabular Labral Reconstruction with Iliotibial Band Autograft: Outcome and Survivorship at a Minimum 10-Year Follow-up. J Bone Joint Surg Am. 2020 Sep 16;102(18):1581-1587. doi: 10.2106/JBJS.19.01499.
• Background Ganz 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.
• Background Rivera E, Seijas R, Rubio M, Garcia-Balletbo M, Vilar JM, Boada PL, Cugat R. Outcomes at 2-Years Follow-Up After Hip Arthroscopy Combining Bone Marrow Concentrate. J Invest Surg. 2020 Aug;33(7):655-663. doi: 10.1080/08941939.2018.1535010. Epub 2019 Apr 7.
• Background Day MA, Hancock KJ, Selley RS, Olsen R, Ranawat AS, Nwachukwu BU, Kelly BT, Nawabi DH. Hip Arthroscopy With Bone Marrow Aspirate Injection for Patients With Symptomatic Labral Tears and Early Degenerative Changes Shows Similar Improvement Compared With Patients Undergoing Hip Arthroscopy With Symptomatic Labral Tears Without Arthritis. Arthroscopy. 2023 Jun;39(6):1429-1437. doi: 10.1016/j.arthro.2022.12.012. Epub 2022 Dec 24.
• Background 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. J Bone Joint Surg Am. 2022 Jan 5;104(1):4-14. doi: 10.2106/JBJS.20.01740.
• Background Menge TJ, Briggs KK, Dornan GJ, McNamara SC, Philippon MJ. Survivorship and Outcomes 10 Years Following Hip Arthroscopy for Femoroacetabular Impingement: Labral Debridement Compared with Labral Repair. J Bone Joint Surg Am. 2017 Jun 21;99(12):997-1004. doi: 10.2106/JBJS.16.01060.
• Background Dwyer MK, Tumpowsky C, Boone A, Lee J, McCarthy JC. What Is the Association Between Articular Cartilage Damage and Subsequent THA 20 Years After Hip Arthroscopy for Labral Tears? Clin Orthop Relat Res. 2019 May;477(5):1211-1220. doi: 10.1097/CORR.0000000000000717.
• Background Dwyer MK, Lee JA, McCarthy JC. Cartilage Status at Time of Arthroscopy Predicts Failure in Patients With Hip Dysplasia. J Arthroplasty. 2015 Sep;30(9 Suppl):121-4. doi: 10.1016/j.arth.2014.12.034. Epub 2015 Jun 3.
• Background Suarez-Ahedo C, Gui C, Rabe SM, Chandrasekaran S, Lodhia P, Domb BG. Acetabular Chondral Lesions in Hip Arthroscopy: Relationships Between Grade, Topography, and Demographics. Am J Sports Med. 2017 Sep;45(11):2501-2506. doi: 10.1177/0363546517708192. Epub 2017 Jun 7.

Drugs

Indications

No indication recorded.