We read with interest the letter from Anitua et al. in response to our randomized, blinded, controlled, clinical trial evaluating the use of plasma rich in growth factors (PRGF) in the repair of the rotator cuff, recently published in Arthroscopy (January 2013). We are grateful for their contribution to improve the discussion on the topic, because we acknowledge that for the design of our randomized controlled trial (RCT), we took into consideration their previous results on the application of PRGF in maxillofacial surgery and orthopaedics and, thereafter, we strictly followed their guidance to prepare the PRGF and their advice for its use in the surgery.
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As we stated, the aim of our RCT was to evaluate a proposed surgical practice through the appropriate methodology (RCT) in response to the recommendation for the use of platelet-rich plasma (PRP) in orthopaedics without sufficient evidence. In this sense, we are very surprised by the statement in the letter of Anitua et al. that they have developed a method and published it in a book (without peer review), pending the results of a clinical trial! In our opinion, the appropriate method is just the opposite: before one suggests a therapeutic intervention, it is absolutely necessary to show efficacy and safety applying the appropriate methodology.
We agree about the important role of mesenchymal stem cells in the tissue repair procedure
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and about the low cellularity present in the repaired rotator cuff tendon. Anitua et al. recommended the infiltration of PRGF in the sites in which lie more mesenchymal stem cells (cancellous bone of the humerus, myotendinous junction, and subacromial deltoid bursa). As such, the use of PRGF in our trial is consistent with their recommendations. As described in our report, we infiltrated PRGF at the repair site and the myotendinous transition. Moreover, at the end of the procedure, without liquid, we deposited PRGF in the subacromial-deltoid bursa. We do not understand the benefit of infiltration of PRGF in the cancellous bone of the greater tuberosity. Instead, a bleeding surface was created with a 4.5-mm bur on the greater tuberosity before the repair. However, and according to our previously stated opinion, any innovation should be supported by the appropriate study.Another issue is the recommendation of Anitua et al. for an ultrasound-guided infiltration of PRGF. However, they recognize that the criteria to make this recommendation are largely arbitrary and, again, based only on their clinical experience.
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So, they will agree that, at present, there is not any scientific evidence to support such a recommendation. Moreover, one cannot ignore that repeated infiltrations increase the risk of infection, and therefore the recommendation should be balanced with regard to risk and benefit. A study by Bergeson et al.5
found a 10% infection rate in the group who received PRP; and the role of PRP injection cannot be discarded.Regarding the mentioned lack of standardization, it seems that Anitua et al. have misunderstood our statement: All the preparations for the trial were prepared strictly in accordance with the methodology described in our article, maintaining consistency during the trial. PRGF was prepared with strict adherence to guidelines previously described by Anitua and colleagues
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and using the same equipment and material. Our mention of the lack of standardization refers to the different methodology used by diverse authors.Finally, we think that orthopaedic surgeons must consider how we are using this type of unproven treatment. Currently, there are no studies with high levels of evidence to support firmly the effectiveness of PRP in the rotator cuff. The unregulated massive application of PRP implies, at a minimum, a huge monetary cost. So, in our opinion, future recommendations about the use of these therapies must be made only after (and never before) the benefit-risk ratio has been established through randomized clinical trials.
References
- Autologous fibrin matrices: A potential source of biological mediators that modulate tendon cell activities.J Biomed Mater Res A. 2006; 77: 285-293
- Use of autologous plasma rich in growth factors in arthroscopic surgery.Cuad Artroscopia. 2003; 10: 12-19
- Why are MSCs therapeutic? New data: New insight.J Pathol. 2009; 217: 318-324
- Platelet-rich plasma in muscle and tendon healing.Oper Tech Orthop. 2012; 22: 16-24
- Effects of platelet-rich fibrin matrix on repair integrity of at-risk rotator cuff tears.Am J Sports Med. 2012; 40: 286-293
- Autologous preparation rich in growth factors promotes proliferation and induce VEGF and HGF production by human tendon cells in culture.J Orthop Res. 2005; 23: 281-286
- Ligamentization of tendon grafts treated with an endogenous preparation rich in growth factors: Gross morphology and histology.Arthroscopy. 2010; 26: 470-480
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- A Biological Approach to Orthopaedic Surgery: Are They Lost in Translation?ArthroscopyVol. 29Issue 6
- PreviewDespite the care and seriousness with which Ruiz-Moneo et al.1 conducted their study “Plasma Rich in Growth Factors in Arthroscopic Rotator Cuff Repair: A Randomized, Double-Blind, Controlled Clinical Trial,” there are methodologic and conclusive issues that we believe would affect the outcomes in this recently published study.
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