Top

BMC Musculoskeletal Disorders

Published in:

Open Access 01-12-2022 | Knee Osteoarthritis | Study protocol

Efficacy of intra-articular injection of allogeneic platelet-rich plasma for knee osteoarthritis combined with hematologic blood dyscrasias with platelet dysfunction: protocol of a randomized, double-blind, placebo-controlled trial

Authors: Xiaohang Zhu, Lingying Zhao, An Liu, Ziqiang Yu, Jiong Jiong Guo

Published in: BMC Musculoskeletal Disorders | Issue 1/2022

Abstract

Background

Autologous platelet-rich plasma (PRP) has been shown to alleviate the symptoms of patients suffering from knee osteoarthritis (KOA), but for certain patients with hematologic diseases with platelet dysfunction and patients receiving anti-platelet medications, autologous PRP is not an optimum solution. Allogeneic PRP has been proven to be safe and effective in the treatment of osteoarthritis, rotator cuff disease, refractory wounds and other medical fields. However, a well-designed and long-term follow-up prospective randomized controlled trial (RCT) to evaluate the effect of allogeneic PRP intra-articular injections for KOA combined with hematologic blood dyscrasias has not yet been performed.

Methods/ design

We will conduct an allogeneic PRP injection for KOA combined with hematologic blood dyscrasias with platelet dysfunction study: a prospective, randomized, double-blind, placebo-controlled trial. One hundred participants with KOA combined with hematologic blood dyscrasias with platelet dysfunction will be randomly allocated to receive either one allogeneic PRP injection or one saline injection into the knee joint. The primary outcome will be a 12-month change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes will be the 36-Item Short-Form General Health Survey (SF-36) score, Lysholm score, overall knee pain score and MRI assessment at 1-, 3-, 6- and 12-month.

Discussion

The results of this study will help determine whether allogeneic PRP could be used as a non-surgical intervention to treat patients with knee OA combined with hematologic blood dyscrasias with platelet dysfunction.

Trial registration

Chinese Clinical Trials Registry reference: ChiCTR2100048624. Prospectively registered 11th of July 2021.

Available only for authorised users

Bennell KL, Paterson KL, Metcalf BR, et al. Effect of intra-articular platelet-rich plasma vs placebo injection on pain and medial Tibial cartilage volume in patients with knee osteoarthritis: the RESTORE randomized clinical trial. JAMA. 2021;326(20):2021–30. https://doi.org/10.1001/jama.2021.19415.CrossRef

Paterson KL, Hunter DJ, Metcalf BR, et al. Efficacy of intra-articular injections of platelet-rich plasma as a symptom- and disease-modifying treatment for knee osteoarthritis - the RESTORE trial protocol. BMC Musculoskelet Disord. 2018;19(1):272.CrossRef

Fice MP, Miller JC, Christian R, et al. The role of platelet-rich plasma in cartilage pathology: an updated systematic review of the basic science evidence. Arthroscopy. 2019;35(3):961–976.e3. https://doi.org/10.1016/j.arthro.2018.10.125.CrossRef

Hohmann E, Tetsworth K, Glatt V. Is platelet-rich plasma effective for the treatment of knee osteoarthritis? A systematic review and meta-analysis of level 1 and 2 randomized controlled trials. Eur J Orthop Surg Traumatol. 2020;30(6):955–67. https://doi.org/10.1007/s00590-020-02623-4.CrossRef

Shen L, Yuan T, Chen S, Xie X, Zhang C. The temporal effect of platelet-rich plasma on pain and physical function in the treatment of knee osteoarthritis: systematic review and meta-analysis of randomized controlled trials. J Orthop Surg Res. 2017;12(1):16. https://doi.org/10.1186/s13018-017-0521-3.CrossRef

Patel S, Dhillon MS, Aggarwal S, Marwaha N, Jain A. Treatment with platelet-rich plasma is more effective than placebo for knee osteoarthritis: a prospective, double-blind, randomized trial. Am J Sports Med. 2013;41(2):356–64. https://doi.org/10.1177/0363546512471299.CrossRef

Huang Z, Chen J, Ma J, Shen B, Pei F, Kraus VB. Effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthr Cartil. 2015;23(9):1437–44. https://doi.org/10.1016/j.joca.2015.04.005.CrossRef

Rodeo SA. A Call for Standardization in Cell Therapy Studies: Commentary on an article by Iain R. Murray, BMedSci(Hons), MRCS, MFSEM, PhD, et al.: "International Expert Consensus on a Cell Therapy Communication Tool: DOSES". J Bone Joint Surg Am. 2019;101(10):e47. https://doi.org/10.2106/JBJS.19.00189.CrossRef

Jo CH, Lee SY, Yoon KS, Oh S, Shin S. Allogenic pure platelet-rich plasma therapy for rotator cuff disease: a bench and bed study. Am J Sports Med. 2018;46(13):3142–54. https://doi.org/10.1177/0363546518800268.CrossRef

10.

Jo CH, Lee SY, Yoon KS, Oh S, Shin S. Allogeneic platelet-rich plasma versus corticosteroid injection for the treatment of rotator cuff disease: a randomized controlled trial. J Bone Joint Surg Am. 2020;102(24):2129–37. https://doi.org/10.2106/JBJS.19.01411.CrossRef

11.

He M, Guo X, Li T, et al. Comparison of allogeneic platelet-rich plasma with autologous platelet-rich plasma for the treatment of diabetic lower extremity ulcers. Cell Transplant. 2020;29:963689720931428. https://doi.org/10.1177/0963689720931428.CrossRef

12.

Bottegoni C, Dei Giudici L, Salvemini S, Chiurazzi E, Bencivenga R, Gigante A. Homologous platelet-rich plasma for the treatment of knee osteoarthritis in selected elderly patients: an open-label, uncontrolled, pilot study. Ther Adv Musculoskelet Dis. 2016;8(2):35–41. https://doi.org/10.1177/1759720X16631188.CrossRef

13.

Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRef

14.

Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. Published 2010 Mar 23. https://doi.org/10.1136/bmj.c332.CrossRef

15.

Saltzman BM, Leroux T, Meyer MA, et al. The therapeutic effect of intra-articular Normal saline injections for knee osteoarthritis: a Meta-analysis of evidence level 1 studies. Am J Sports Med. 2017;45(11):2647–53. https://doi.org/10.1177/0363546516680607.CrossRef

16.

Hmamouchi I, Allali F, Tahiri L, et al. Clinically important improvement in the WOMAC and predictor factors for response to non-specific non-steroidal anti-inflammatory drugs in osteoarthritic patients: a prospective study. BMC Res Notes. 2012;5:58. Published 2012 Jan 23. https://doi.org/10.1186/1756-0500-5-58.CrossRef

17.

Harris JD, Brand JC, Cote MP, Faucett SC, Dhawan A. Research pearls: the significance of statistics and perils of pooling. Part 1: clinical versus statistical significance. Arthroscopy. 2017;33(6):1102–12. https://doi.org/10.1016/j.arthro.2017.01.053.CrossRef

18.

McAlindon TE, Driban JB, Henrotin Y, et al. OARSI clinical trials recommendations: design, conduct, and reporting of clinical trials for knee osteoarthritis. Osteoarthr Cartil. 2015;23(5):747–60. https://doi.org/10.1016/j.joca.2015.03.005.CrossRef

19.

Bailey CS, Rasoulinejad P, Taylor D, et al. Surgery versus conservative Care for Persistent Sciatica Lasting 4 to 12 months. N Engl J Med. 2020;382(12):1093–102. https://doi.org/10.1056/NEJMoa1912658.CrossRef

20.

Lins L, Carvalho FM. SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016;4:2050312116671725. Published 2016. https://doi.org/10.1177/2050312116671725.CrossRef

21.

Briggs KK, Steadman JR, Hay CJ, Hines SL. Lysholm score and Tegner activity level in individuals with normal knees. Am J Sports Med. 2009;37(5):898–901. https://doi.org/10.1177/0363546508330149.CrossRef

22.

Hunter DJ, Guermazi A, Lo GH, et al. Evolution of semi-quantitative whole joint assessment of knee OA: MOAKS (MRI osteoarthritis knee score) [published correction appears in osteoarthritis cartilage. 2011 Sep;19(9):1168]. Osteoarthr Cartil. 2011;19(8):990–1002. https://doi.org/10.1016/j.joca.2011.05.004.CrossRef

23.

Wluka AE, Stuckey S, Snaddon J, Cicuttini FM. The determinants of change in tibial cartilage volume in osteoarthritic knees. Arthritis Rheum. 2002;46(8):2065–72. https://doi.org/10.1002/art.10460.CrossRef

24.

Carpenter JG, Kenward MG. Multiple imputation and its application. West Sussex: John Wiley & Sons Ltd; 2013.CrossRef

25.

Lin KY, Yang CC, Hsu CJ, Yeh ML, Renn JH. Intra-articular injection of platelet-rich plasma is superior to hyaluronic acid or saline solution in the treatment of mild to moderate knee osteoarthritis: a randomized, double-blind, triple-parallel. Placebo-Control Clin Trial Arthroscopy. 2019;35(1):106–17. https://doi.org/10.1016/j.arthro.2018.06.035.CrossRef

26.

James KE, Bloch DA, Lee KK, Kraemer HC, Fuller RK. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation–a VA cooperative study. Stat Med. 1996;15(13):1421–34.CrossRef

Title: Efficacy of intra-articular injection of allogeneic platelet-rich plasma for knee osteoarthritis combined with hematologic blood dyscrasias with platelet dysfunction: protocol of a randomized, double-blind, placebo-controlled trial
Authors: Xiaohang Zhu
Lingying Zhao
An Liu
Ziqiang Yu
Jiong Jiong Guo
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Knee Osteoarthritis
Osteoarthrosis
Osteoarthrosis
Knee Osteoarthritis
Published in: BMC Musculoskeletal Disorders / Issue 1/2022
Electronic ISSN: 1471-2474
DOI: https://doi.org/10.1186/s12891-022-06073-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy of intra-articular injection of allogeneic platelet-rich plasma for knee osteoarthritis combined with hematologic blood dyscrasias with platelet dysfunction: protocol of a randomized, double-blind, placebo-controlled trial

Abstract

Background

Methods/ design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/ design

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

Effects of autogenic and reciprocal inhibition techniques with conventional therapy in mechanical neck pain – a randomized control trial

Construct validity and reliability of the 2-minute step test in patients with knee osteoarthritis

Increase in tibial internal rotation due to weight-bearing is a key feature to diagnose early-stage knee osteoarthritis: a study with upright computed tomography

Non-operative treatment or volar locking plate fixation for dorsally displaced distal radius fractures in patients over 70 years – a three year follow-up of a randomized controlled trial

Predictors of self-management in patients with chronic low back pain: a longitudinal study

Continuous care intervention with carbohydrate restriction improves physical function of the knees among patients with type 2 diabetes: a non-randomized study