Authors' Reply

Abstract

We greatly appreciate the comments made by Drs. Waterman and Johnson regarding our publication in the ISAKOS Biologics Series Part II supplement of the May 2015 issue of Arthroscopy, entitled “Synthetic Devices for Reconstructive Surgery of the Cruciate Ligaments: A Systematic Review,”1Batty L.M. Norsworthy C.J. Lash N.J. Wasiak J. Richmond A.K. Feller J.A. Synthetic devices for reconstructive surgery of the cruciate ligaments: A systematic review.Arthroscopy. 2015; 31: 957-968Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar along with the editorial comment made by Dr. Lubowitz in the same supplement.2Lubowitz J.H. Editorial commentary: Synthetic ACL grafts are more important than clinical nonbelievers may realize.Arthroscopy. 2015; 31: 969-970Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar The Ligament Augmentation and Reconstruction System (LARS) device, in particular, draws the most attention. There are inherent weaknesses in systematic reviews, at least in part due to reporting biases, such as publication bias and outcome reporting bias.3Page M.J. McKenzie J.E. Kirkham J. et al.Bias due to selective inclusion and reporting of outcomes and analyses in systematic reviews of randomised trials of healthcare interventions.Cochrane Database Syst Rev. 2014; 10: MR000035PubMed Google Scholar, 4Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. Oxford, England: The Cochrane Collaboration, 2011. Available at www.cochrane-handbook.org. Updated March 2011. Accessed July 10, 2015.Google Scholar In the Discussion section of this review, we allude to “the paucity of well-conducted clinical trials” that qualified for inclusion. We did not attempt to locate unpublished material, and we excluded non–English-language studies. Both of these factors may have resulted in the omission of papers reporting poor outcomes for synthetic devices. While we respect that Drs. Waterman and Johnson have anecdotally identified a 40% failure rate for the LARS posterior cruciate ligament device in their own patients, we were unable to identify any publication reporting this figure or others with similar experiences. Therefore it was not possible to include such data in the systematic review. Aseptic synovitis may well be a concern in knees that have undergone LARS surgery. The cited publication on this subject was a case report5Glezos C.M. Waller A. Bourke H.E. Salmon L.J. Pinczewski L.A. Disabling synovitis associated with LARS artificial ligament use in anterior cruciate ligament reconstruction: A case report.Am J Sports Med. 2012; 40: 1167-1171Crossref PubMed Scopus (43) Google Scholar and, therefore, did not meet the inclusion criteria for our systematic review. We did not find that the literature is replete with publications reporting that synovitis is a major complication of the use of the LARS device. Our personal anecdotal experience does, however, suggest that the rate of synovitis is higher than the figures reported in the review (0.2% to 1.3%). Once again, the discrepancy is potentially a consequence of outcome reporting or publication bias. As we emphasized in the review, only half of the LARS studies reported on sterile effusion and synovitis and we still maintain that the “apparently lower incidence should therefore be interpreted with caution.”1Batty L.M. Norsworthy C.J. Lash N.J. Wasiak J. Richmond A.K. Feller J.A. Synthetic devices for reconstructive surgery of the cruciate ligaments: A systematic review.Arthroscopy. 2015; 31: 957-968Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar While none of the authors recommend the use of the LARS device in elite-level athletes, we do note with interest that there are at least 3 professional Australian Rules footballers currently playing at the highest level for more than 2 seasons after an anterior cruciate ligament reconstruction using the LARS device. Whatever the personal opinions of the authors of the systematic review might be, the findings of the systematic review reflect the currently available literature. Unfortunately, this is composed of Level II to IV studies with variability and heterogeneity in outcome reporting as we describe. Whether or not ligament repair, perhaps in combination with an internal brace of appropriate material, becomes a successful innovation in the treatment of the cruciate-injured knee—as speculated by Drs. Waterman and Johnson, as well as Dr. Lubowitz—remains to be seen. In the future, we feel that reporting standard outcomes in conjunction with rigorous clinical trials will allow unbiased comparison and facilitate systematic review and meta-analysis to evaluate treatments for the anterior cruciate–deficient knee, including an internal brace. Synthetic Grafts—Where Is the Common Sense?ArthroscopyVol. 31Issue 10PreviewWith great interest, we recently read the article entitled “Synthetic Devices for Reconstructive Surgery of the Cruciate Ligaments: A Systematic Review” published in the May 2015 issue of Arthroscopy.1 Thank you for acknowledging our skepticism about the resurgent use of synthetic grafts in your editorial commentary.2 At first blush, this systematic review of synthetic implants, particularly the Ligament Augmentation and Reconstruction System (LARS) device (Surgical Implants and Devices, Arc-sur-Tille, France), shows quite good results, almost too good to be true. Full-Text PDF