My name is Fernando Oran. I'm presenting effectiveness of Halox valgus surgery on post-operative outcomes in skeletally mature patients for the AOFAS summer meeting. No personal disclosures, the Actel and clinical research team that helped with this review was funded by Treece Medical Concepts. The goal of this paper was really to establish a baseline for comparison for Halox valgus patient reported outcomes. There are a few good systematic reviews out there like Klugerova and Barg et al, but they had difficulties making sense of the heterogeneity in the literature, drawing any conclusions or establishing a historical benchmark to compare to. We aim to do a systematic review of recent literature from 2001 to the present with the idea of having a more modern reference system for Halox valgus surgery, looking at patient reported outcomes. Our inclusion criteria, skeletally mature patients with Halox valgus requiring surgical correction, minimum one-year follow-up, exclusion criteria, anybody who had had previous Halox valgus surgery, arthrodesis or arthroplasty, the first MTP, cohorts with inflammatory arthropathy or neurologic conditions. We looked at 5,544 abstracts. Of those, 1,200 underwent full-text article eligibility, and of those, we selected 310 articles for qualitative synthesis. The majority of our papers were retrospective. There were 28.1% that were prospective. The level of evidence, again, was relatively low, as you would expect in this type of large review, but 74% were retrospective comparative or case-controlled series, and 64.5% were case series. There were 401 total cohorts. The number of patients was 21,109, and about two-thirds of them were female. The patient-reported outcomes that were used, by far and large, AOFAS was the largest with 259 of the 400 or so cohorts, and VASPANE was the second at 67. Again, as we all know, there are a lot of different ways to do bunion surgery, but the two most common were SCARF and Chevron in this review. We decided to group by osteotomy site because there was really too many variations of surgeries to effectively compare and display on a table. We thought that looking at the metatarsal itself as a reference point for where the correction was being done was a good way to visualize this. The biggest thing about this paper that I want people to take away is how can you standardize patient-reported outcomes so you don't have to think about the individual scale? Our big goal was really to establish a way to look at clinical effect size of surgeries and of interventions. The fundamental question we're always looking for is, did the intervention create a clinically significant change, either positive or negative, but is it clinically significant? By dividing, basically, each one of these scores by their MCID, you get a clinical effect size where greater than one is significant and less than one is not. Here's our main table, which really looks at the osteotomy by site and its clinical effect size overall. As you can see, this is something we understand fundamentally, but the metatarsal osteotomies to correct bunion deformities or hallux valgus deformities all had a positive clinical effect size with an average of 1.27. The double osteotomy did have the largest positive effect. It did also have higher complication rates, and it was a smaller cohort than the others, but the big thing to look at is, while all the metatarsal osteotomies were greater than one clinical effect size, if you look at the soft tissue procedures, plus or minus Aiken, really the soft tissue procedures without a corrective metatarsal osteotomy did not meet positive clinical significance as far as an intervention is concerned. Again, I think we all kind of understand this and think about this fundamentally, but we were able to show it in our data. As far as complications were concerned, again, the long-term recurrence is something we're always focused on. If you look at the other group, as we said, the soft tissue plus or minus Aiken without a corrective metatarsal osteotomy, the recurrence rate greater than three years was about 30%, and if you look at all the other metatarsal osteotomies, they had much lower long-term recurrence rates. Looking at each patient-reported outcome measure individually, you realize that there really is a lot of room for the scale to determine clinical effect size, and the more subjective a score is, the less sensitive it is for clinically significant difference, and the more objective it is, the larger the clinical effect size you're going to measure. The AOFAS clinical effect size at 1.27 was positive and greater than one, but the MOX-FQ for the same types of interventions, although much smaller numbers in the MOX-FQ, when you look at the scoring rubric individually, there are a lot more direct qualifiers and objective measures, and this may allow you to have a larger clinical effect size be measured. Looking at vast pain, which really is mostly a subjective scoring rubric, you see that the interventions, none of them really met clinical significance as far as pain is concerned with an overall improvement of 0.87. We also looked at all of these surgeries, MIS versus open satisfaction complications. So their HVA and IMA corrections were all statistically similar. The satisfaction rate was significantly higher in the open, but at 2%, it probably is not clinically significant. So our conclusion, the traditional bunion surgeries had an aggregate mean improvement of 1.27. Again, I think this is very important to have an established baseline of clinical effect size that we can then compare our future outcomes to. Again, the double osteotomies had the greatest overall change with an overall mean improvement of 1.69. Although it had the highest positive change, the double osteotomies had the highest complications rates with overall recurrence rates of 11.2, myeloinunion of 4.8, and avascular necrosis of 3.2%. All metatarsal osteotomies were superior to soft tissue procedures plus or minus Aiken, which had the highest long-term recurrence of 29.6%. Discussion, this is really the biggest modern review to date. First time MCID was used to aggregate data and compare across scales. Using 1.27 clinical effect size as a historical benchmark to compare patient-reported outcomes going forward is beneficial. It's an important baseline, but there are certain shortcomings inherent to the bias in the literature and really to the scoring rubric we used. Promise scores are probably a better score to use moving forward, but the established baseline from this study is mostly derived from AOFAS score. We can normalize promise scores based on MCID and compare to the clinical effect size of 1.27 for historical outcomes going forward. Using this study, hopefully we can move forward and better understand our interventions are performing compared to a historical benchmark. Thank you.

Halox valgus surgery

post-operative outcomes

skeletally mature patients

metatarsal osteotomies

patient-reported outcomes