Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Dec 14;23(1):1095.
doi: 10.1186/s12891-022-06073-3.

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

Xiaohang Zhu #  1 , Lingying Zhao #  2   3 , An Liu  2   4 , Ziqiang Yu  2   3 , Jiong Jiong Guo  5   6
Affiliations

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

Xiaohang Zhu et al. BMC Musculoskelet Disord. .

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.

Keywords: Allogeneic platelet-rich plasma; Clinical trial; Hematologic blood dyscrasias; Knee osteoarthritis; Platelet dysfunction.

PubMed Disclaimer

Conflict of interest statement

Each author certifies that he or she has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. We declare that Regen Lab Switzerland have no influence on the collection, analysis or interpretation of study findings. JJG is a Senior Editorial Board Member of BMC Musculoskeletal Disorders.

Figures

Fig. 1
Fig. 1
Flow diagram of the study protocol
See this image and copyright information in PMC

References

    1. 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):2021–2030. doi: 10.1001/jama.2021.19415. - DOI - PMC - PubMed
    1. 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. doi: 10.1186/s12891-018-2205-5. - DOI - PMC - PubMed
    1. 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. doi: 10.1016/j.arthro.2018.10.125. - DOI - PubMed
    1. 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):955–967. doi: 10.1007/s00590-020-02623-4. - DOI - PubMed
    1. 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. doi: 10.1186/s13018-017-0521-3. - DOI - PMC - PubMed

Publication types

MeSH terms

Substances