The Effect of Combined Bone Marrow Aspirate, Lipoaspirate, and Platelet-Rich Plasma Injections on Pain, Function, and Perceived Change Amongst Individuals with Glenohumeral Osteoarthritis A Pilot Study
Main Article Content
Keywords
joint diseases, knee, platelet-rich plasma, stem cells
Abstract
Purpose: This study was conducted to investigate the efficacy of a combined minimally processed bone marrow aspirate (BMA), adipose graft, and leukocyte-rich platelet-rich plasma (PRP) intra-articular injection series on pain, function, and global rating of change (GROC) among patients with glenohumeral osteoarthritis (GHOA) and record any complications or adverse events associated with the protocol.
Methods: Ten adults (mean age 65 years) previously recalcitrant to conservative care with clinical and radiographic evidence of GHOA were included. At the initial visit, patients were assessed for eligibility of treatment. All patients were assessed pre- and post-treatment with numerical pain rating and patient-specific functional scales (PSFS). All study participants were treated with 4–6 ml of PRP, 6 ml adipose graft, and 12 ml of BMA, which were administered via a landmark-based anterior intra-articular injection. Patients were requested to return twice over 4-week intervals for booster PRP injections. At each follow-up, the GROC and prior outcome measures were completed.
Results: Patients returned after an average of 27 days for first (F1) and 68 days for the second (F2) PRP injection. Friedman Chi Square analysis indicated significant improvements in best and worse pain and PSFS from baseline initial visit to F1 and F2 (P ≤ .002). Post-hoc Wilcoxon signed-rank testing with Bonferroni correction (α = 0.017) identified significant improvements from baseline to F1 and F2 for the PSFS (P ≤ 0.012). Improvements in best and worse pain were significant at F2 (P ≤ 0.016), not F1 (P ≥ 0.02), compared to baseline. Effect sizes were large, ranging from r = 0.57 to 0.84 for pain and function. Improvements in pain, GROC, and PSFS met minimum clinically important differences at F2 based on previously validated clinimetrics. The only adverse events reported are related to administration of injectate that was temporary and managed in all cases with over-the-counter analgesics.
Conclusion: A minimally processed adipose graft with BMA and three PRP injections improved pain and function among individuals with GHOA who were recalcitrant to conservative care. Although significant functional improvement at both follow-up points occurred, clinically important and significant changes in pain did not occur until F2. A one-group design and multimodal approach limit generalization of results.
Level of Evidence: IV
References
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2. Khazzam M, Gee AO, Pearl M. Management of glenohumeral joint osteoarthritis. J Am Acad Orthop Surg. 2020;28(19):781–9. https://doi.org/10.5435/jaaos-d-20-00404
3. Rossi LA, Piuzzi NS, Shapiro SA. Glenohumeral osteoarthritis: The role for orthobiologic therapies: Platelet-rich plasma and cell therapies. JBJS Rev. 2020;8(2):e0075. https://doi.org/10.2106/jbjs.Rvw.19.00075
4. Craig RS, Lane JCE, Carr AJ, et al. Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: Population based cohort study using hospital episode statistics for England. Bmj. 2019;364:l298. https://doi.org/10.1136/bmj.l298
5. Carey K, Morgan JR. Payments for outpatient joint replacement surgery: A comparison of hospital outpatient departments and ambulatory surgery centers. Health Serv Res. 2020;55(2):218–23. https://doi.org/10.1111/1475-6773.13262
6. Kunze KN, Fontana MA, MacLean CH, et al. Defining the patient acceptable symptom state for the HOOS JR and KOOS JR after primary total joint arthroplasty. J Bone Joint Surg Am. 2022;104(4):345–52. https://doi.org/10.2106/jbjs.21.00550
7. Gobbi A, Dallo I, Rogers C, et al. Two-year clinical outcomes of autologous microfragmented adipose tissue in elderly patients with knee osteoarthritis: A multi-centric, international study. Int Orthop. 2021;45(5):1179–88. https://doi.org/10.1007/s00264-021-04947-0
8. Centeno CJ, Al-Sayegh H, Bashir J, et al. A prospective multi-site registry study of a specific protocol of autologous bone marrow concentrate for the treatment of shoulder rotator cuff tears and osteoarthritis. J Pain Res. 2015;8:269–76. https://doi.org/10.2147/jpr.S80872
9. Centeno CJ, Al-Sayegh H, Freeman MD, et al. A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions. Int Orthop. 2016;40(8):1755–65. https://doi.org/10.1007/s00264-016-3162-y
10. Kolber MJ, Purita J, Sterling B, et al. Stem cell injections for musculoskeletal pathology: An overview for the sports medicine professional. Strength Cond J. 2019;41(6):75–86. https://doi.org/10.1519/SSC.0000000000000500
11. Barry FP, Murphy JM. Mesenchymal stem cells: Clinical applications and biological characterization. Int J Biochem Cell Biol. 2004;36(4):568–84. https://doi.org/10.1016/j.biocel.2003.11.001
12. Noël D, Djouad F, Jorgense C. Regenerative medicine through mesenchymal stem cells for bone and cartilage repair. Current opinion in investigational drugs (London, England: 2000). 2002;3(7):1000–4.
13. Caplan AI. Why are MSCs therapeutic? New data: New insight. J Pathol. 2009;217(2):318–24. https://doi.org/10.1002/path.2469
14. Meirelles Lda S, Fontes AM, et al. Mechanisms involved in the therapeutic properties of mesenchymal stem cells. Cytokine Growth Factor Rev. 2009;20(5–6):419–27. https://doi.org/10.1016/j.cytogfr.2009.10.002
15. Djouad F, Bouffi C, Ghannam S, et al. Mesenchymal stem cells: Innovative therapeutic tools for rheumatic diseases. Nat Rev Rheumatol. 2009;5(7):392–9. https://doi.org/10.1038/nrrheum.2009.104
16. da Silva Meirelles L, Caplan AI, Nardi NB. In search of the in vivo identity of mesenchymal stem cells. Stem Cells (Dayton, Ohio). 2008;26(9):2287–99. https://doi.org/10.1634/stemcells.2007-1122
17. Najar M, Raicevic G, Crompot E, et al. The immunomodulatory potential of mesenchymal stromal cells: A story of a regulatory network. J Immunother. 2016;39(2):45–59. https://doi.org/10.1097/cji.0000000000000108
18. Purita J, Lana J, Kolber M, et al. Bone marrow-derived products: A classification proposal - bone marrow aspirate, bone marrow aspirate concentrate or hybrid? World J Stem Cells. 2020;12(4):241–50. https://doi.org/10.4252/wjsc.v12.i4.241
19. Caplan AI. Mesenchymal stem cells. J Orthop Res. 1991;9(5):641–50. https://doi.org/10.1002/jor.1100090504
20. Barry F, Murphy M. Mesenchymal stem cells in joint disease and repair. Nat Rev Rheumatol. 2013;9(10):584–94. https://doi.org/10.1038/nrrheum.2013.109
21. Prockop DJ, Olson SD. Clinical trials with adult stem/progenitor cells for tissue repair: Let’s not overlook some essential precautions. Blood. 2007;109(8):3147–51. https://doi.org/10.1182/blood-2006-03-013433
22. Beane OS, Fonseca VC, Cooper LL, et al. Impact of aging on the regenerative properties of bone marrow-, muscle-, and adipose-derived mesenchymal stem/stromal cells. PLoS One. 2014;9(12):e115963. https://doi.org/10.1371/journal.pone.0115963
23. Striano RD, Malanga AG, Bilbool N, et al. Refractory shoulder pain with osteoarthritis, and rotator cuff tear, treated with micro-fragmented adipose tissue. J Orthop Spine Sports Med. 2018;2(1):014.
24. Schumaier A, Abboud J, Grawe B, et al. Evaluating glenohumeral osteoarthritis: The relative impact of patient age, activity level, symptoms, and Kellgren–Lawrence grade on treatment. Arch Bone Jt Surg. Mar 2019;7(2):151–60.
25. Mintken PE, Glynn P, Cleland JA. Psychometric properties of the shortened Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH) and Numeric Pain Rating Scale in patients with shoulder pain. J Shoulder Elbow Surg. 2009;18(6):920–6. https://doi.org/10.1016/j.jse.2008.12.015
26. Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014;44(8):560–4. https://doi.org/10.2519/jospt.2014.5248
27. Koehorst ML, van Trijffel E, Lindeboom R. Evaluative measurement properties of the patient-specific functional scale for primary shoulder complaints in physical therapy practice. J Orthop Sports Phys Ther. 2014;44(8):595–603. https://doi.org/10.2519/jospt.2014.5133
28. Dregalla RC, Herrera JA, Koldewyn LS, et al. The choice of anticoagulant influences the characteristics of bone marrow aspirate concentrate and mesenchymal stem cell bioactivity in vitro. Stem Cells Int. 2022;2022:8259888. https://doi.org/10.1155/2022/8259888
29. Chen L, Ye L, Liu H, et al. Extracorporeal shock wave therapy for the treatment of osteoarthritis: A systematic review and meta-analysis. BioMed Res Int. 2020;2020:1907821. https://doi.org/10.1155/2020/1907821
30. Ji Q, He C. Extracorporeal shockwave therapy promotes chondrogenesis in cartilage tissue engineering: A hypothesis based on previous evidence. Med Hypotheses. 2016;91:9–15. https://doi.org/10.1016/j.mehy.2016.03.013
31. Pigozzi F, Giombini A, Parisi A, et al. The application of shock-waves therapy in the treatment of resistant chronic painful shoulder. A clinical experience. J Sports Med Phys Fitness. 2000;40(4):356–61.
32. Zhang H, Li ZL, Yang F, et al. Radial shockwave treatment promotes human mesenchymal stem cell self-renewal and enhances cartilage healing. Stem Cell Res Ther. Mar 9 2018;9(1):54. https://doi.org/10.1186/s13287-018-0805-5
33. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407–15. https://doi.org/10.1016/0197-2456(89)90005-6
34. Bobos P, Ziebart C, Furtado R, et al. Psychometric properties of the global rating of change scales in patients with low back pain, upper and lower extremity disorders. A systematic review with meta-analysis. J Orthop. 2020;21:40–8. https://doi.org/10.1016/j.jor.2020.01.047
35. Tomczak M, Tomczak E. The need to report effect size estimates revisited. An overview of some recommended measures of effect size. TRENDS Sports Sci. 2014;1(21):19–25.
36. Fritz CO, Morris PE, Richler JJ. Effect size estimates: Current use, calculations, and interpretation. J Exp Psychol Gen. 2012;141(1):2–18. https://doi.org/10.1037/a0024338
37. Cohen J. Statistical power analysis for the behavioral sciences. 2nd ed. Hillsdale, NJ: Erlbaum; 1988.
38. U.S. Food and Drug Administration. Regulatory considerations for human cells, tissues, and cellular and tissue-based products: Minimal manipulation and homologous use. Guidance for industry and Food and Drug Administration. 2020. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal
39. Piuzzi NS, Hussain ZB, Chahla J, et al. Variability in the preparation, reporting, and use of bone marrow aspirate concentrate in musculoskeletal disorders: A systematic review of the clinical orthopaedic literature. J Bone Joint Surg Am. 2018;100(6):517–25. https://doi.org/10.2106/jbjs.17.00451
40. Dwyer T, Hoit G, Lee A, et al. Injection of bone marrow aspirate for glenohumeral joint osteoarthritis: A pilot randomized control trial. Arthrosc Sports Med Rehabil. 2021;3(5):e1431–e1440. https://doi.org/10.1016/j.asmr.2021.07.005
41. Vinet-Jones H, Darr KF. Clinical use of autologous micro-fragmented fat progressively restores pain and function in shoulder osteoarthritis. Regen Med. 2020;15(10):2153–61. https://doi.org/10.2217/rme-2020-0069
42. Kany J, Benkalfate T, Favard L, et al. Osteoarthritis of the shoulder in under-50 year-olds: A multicenter retrospective study of 273 shoulders by the French Society for Shoulder and Elbow (SOFEC). Orthop Traumatol Surg Res. 2021;107(1):102756. https://doi.org/10.1016/j.otsr.2020.102756
43. Darrow M, Shaw B, Schmidt N, et al. Treatment of shoulder osteoarthritis and rotator cuff tears with bone marrow concentrate and whole bone marrow injections. Cogent Med. 2019;6(1): 1628883. https://doi.org/10.1080/2331205X.2019.1628883
44. Kirschner JS, Cheng J, Creighton A, et al. Efficacy of ultrasound-guided glenohumeral joint injections of leukocyte-poor platelet-rich plasma versus hyaluronic acid in the treatment of glenohumeral osteoarthritis: A randomized, double-blind controlled trial. Clin J Sport Med. 2022;32(6):558–66. https://doi.org/10.1097/jsm.0000000000001029
45. European Union Commission Directive. 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products. OJEU. 2009;242:3–12.
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Nov 30, 2022
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How to Cite
Kolber, M., Purita, J., & Hanney, W. (2022). The Effect of Combined Bone Marrow Aspirate, Lipoaspirate, and Platelet-Rich Plasma Injections on Pain, Function, and Perceived Change Amongst Individuals with Glenohumeral Osteoarthritis: A Pilot Study. Biologic Orthopedics Journal, 4(SP1), e83-e95. https://doi.org/10.22374/boj.v4iSP1.49
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Author Biographies
Morey Kolber, Nova Southeastern University, Lauderdale, FL, USA
Department of Physical Therapy, Nova Southeastern University, Lauderdale, FL, USA
Joseph Purita, Institute of Regenerative Medicine, Boca Raton, FL, USA
Institute of Regenerative Medicine, Boca Raton, FL, USA
William Hanney, University of Central Florida, Orlando, FL, USA
School of Kinesiology & Physical Therapy, University of Central Florida, Orlando, FL, USA