This letter addresses the article by Sayed, et al.1 My focus is on Surgical Techniques-Minimally Invasive Approaches and addresses the Minimally Invasive Posterior SI Fusion with Allograft.
They state, using their most recent prospective publication,2 that pain scores, ODI, and Promis 29 were all significantly improved at 12 months. The data they offer to make these statements is severely flawed. They accepted 117 implanted patients into this prospective study. At 12 months, 34 patients or 29% (34/117), were unaccounted for. They looked at VAS scores on the 83 patients that showed up for the 12-month F/U and found 51 having an improvement of at least 50%. Their calculation was a 61.4% (51/83) improvement. My calculation for this is a 44% (51/117) improvement. They looked at ODI results and state that 68.7% (57/83) had significant clinical improvement. My calculation for this is that 49% (57/117) patients had significant clinical improvement. Using their data, less than 50% of the patients they originally started with and accepted into their study had significant clinical improvement at 12 months F/U.
There is much more to say, but I am restrained by the 500-word letter to Editor limit.
This current publication1 is outlining “Guidelines” for clinicians and surgeons to help guide them to make the best decisions affecting real patients. The following are my reasons why this section on the use of Allograft for SI joint fusions should be removed from this “Guidelines” publication.
Scientifically relevant conclusions cannot be made on “prospective data” when almost 30% of that data is missing.2 What about the missing 34 patients.2 Could they have had infections or allograft failures with some resulting in revisions? Could some be in severe chronic pain or have lasting morbidities? They just simply do not have this data. In a paper discussing surgical fusion options there is no mention in this paper1 or their long-term follow-up study2 of allograft placement and fusion status. There are no post-operative images1,2 clearly defining whether it’s intra-articular, extra-articular, fused or not fused. 12-month follow ups are inadequate for a procedure to be listed in a “use this” “Guideline” publication. This is not a standard operation for the publishing of true scientific data, conclusions, and recommendations. As stated in this publication1 it was primarily funded by the company that provides this surgical allograft implant, and the primary author is a consultant for this company. DisclosureThe author reports no conflicts of interest in this communication.
References1. Sayed D, Deer T, Francio V, et al. American Society of Pain and Neuroscience Best Practice (ASPN) guideline for the treatment of sacroiliac disorders. J Pain Res. 2024;17:1601–1638. doi:10.2147/JPR.S464393
2. Calodney A, Azeem N, Buchanan P, et al. Safety, efficacy, and durability of outcomes: results from SECURE: a single arm, multicenter, prospective, clinical study on a minimally invasive posterior sacroiliac fusion allograft implant. J Pain Res. 2024;17:1209–1222. doi:10.2147/JPR.S458334
留言 (0)