Episode Transcript
[00:00:02] Speaker A: Welcome to your Cases on Hold, the JVGS Podcast, hosted by Andrew Schoenfeld and Aisha Adkeen.
[00:00:08] Speaker B: Here we discuss the best of what each issue of JBJS has to offer with the usual dose of entertainment and pop culture.
[00:00:16] Speaker A: Take us with you in the gym, on the commute, and as ever, whenever your case is on hold.
[00:00:26] Speaker B: Hello and welcome Back to episode 110 of your case is on Hold. If you are listening on the day we drop, it's July 14th for the July 15th issue of JBJS. I hope you're having a great summer listening to us somewhere out on the beach while we bring you the hot off the presses articles from the Journal My name is Aisha Abdeen, Chief of the Division of Hip and Knee Arthroplasty at Boston Medical center and Associate professor of Orthopedic Surgery at Boston University, and
[00:00:51] Speaker A: I have with me I am Andrew Schoenfeld, professor of Orthopedic Surgery, Vice Chair for Education at Harvard Medical School.
[00:00:59] Speaker B: As a reminder, the opinions expressed here are exclusively our own and do not represent those of jbjs, the editorial board, the Board of Directors, nor the affiliate journals of jbjs.
This podcast is brought to you today by JVGS Clinical Classroom for Clinical Practice, Lifelong Learning, Exam Prep and Continuing Education that'll take you from med school to practice.
So let's get right into it. We have the top of the pile. What's New in Musculoskeletal Infection Recapturing the Joy of Orthopedic Surgery, A Focus on Professionalism and stewardship by DiCaprio, who states that a meaningful career in orthopedics is much more profound than just doing 12 joints by noon. Are we sure about that?
Give it a read. It's inspirational.
Beyond Case Defining Quality and Accountability in Short Term Arthroplasty Missions by Siddiqui and Resampling a beautiful and symbolic Poem by Appal. It's Permanently Free Evolution of Third Party Involvement in Orthopedics by Toussaint Outpatient Total Joint Arthroplasty Future directions by Liu3 Dimensional geometry of the Normal Scapula, A Software Analysis by Werthell. There's a commentary on this one.
For our headlines, Andrew will present our first paper, Clinical Outcomes Following Open Tibial Fractures in Latin America, A Multicenter prospective study by McKechnie. We have the trifecta of a commentary, a highlight, and it is permanently free.
[00:02:30] Speaker A: All right, so this is a study that was done in collaboration with 18 trauma centers in eight countries between 2018 and 2022, spearheaded by the Actuar Study Group and the team out of UCSF.
The premise, so you see the title and I'm like, okay, so what is it about clinical outcomes following open tibial fractures, something that is especially well studied for decades in Latin America that requires a multicenter prospective study?
The author's answer to that is surgeons in Latin America often have to rely on studies from higher resource regions which may not be fully applicable to their patient populations. Recognizing the need to better understand open tibial fracture management in this region, this study sought to compare health related quality of life and fracture healing based on fixation strategies following open tibial fractures in Latin America. Okay, I mean that I can accept that. I would say that with that as the motivating premise. What this really is, is a prospective observational data collection, a report of prospective observational data collection from multiple centers. If it was done for the purposes of just standard patient care and then analyzed retrospectively, that really has the same threats to validity that it does. If it was collected prospectively.
Maybe you could make the argument, well, there'll be fewer patients lost to follow up, less missing data, and that would all be acceptable were that actually the case. Which, surprise ending, it isn't.
It's a challenging population to take care of, of course, and it seems like that is no different in the United States than in Latin America. So they had 422 patients that provided consent and enrolled. Of these, 389 had a baseline evaluation, which is already a surprising drop off since you'd expect the baseline evaluation to happen at the time that the 352 had at least one follow up and then 309 had at least one SF12 and radiographic follow up.
Again, let's just come back to the premise here. The premise being that surgeons in Latin America have to rely on states from higher resource regions. And, and it may not be fully applicable, presumably challenges in terms of delayed, you know, they talk about delayed presentation, delayed time to surgery, issues with resource limitations and resources.
And you know, these are big countries that the studies conducted in Mexico had the highest proportion. About a third of the patients came from Mexico, which in and of itself is a huge country with lots of different areas. And you know, Mexico City as compared to Juarez, as compared to someplace in the Yucatan, as compared to Oaxaca or somewhere in Baja California. Like, these are all as drastically different as Boston to Minot, North Dakota. You see, you know what I'm saying? Like, but here's the part that really started to, you know, the premise again, Is like, we need data specific to Latin America because there are all these challenges.
That means that the patient cohort should be appropriately challenged. Most patients, 73% traveled less than 25 kilometers for definitive care.
The median time from injury to the initial surgery was approximately seven hours for Gasteel Anderson type 1, 2 and 3A fractures and less than six hours for type 3B and C fractures.
This to me looks just like the care that I think you would get in most settings in the us. Like,
[00:06:39] Speaker B: yeah, I was expecting longer if they didn't have a trauma room or the resources that they don't have.
[00:06:46] Speaker A: Or in some places this may be better.
[00:06:51] Speaker B: Yeah, absolutely right, Yep.
[00:06:54] Speaker A: So, you know, the main difference here is that they found a lot more staged intramedullary nailing as compared to definitive initial intramedullary narrowing. That's probably one of like the most significant findings that they have. And they say that staged intramedullary nailing was nearly as common for less severe fracture types. And this contrasts with the literature from high income countries where lower grade open fractures are predominantly treated with initial intramedulling. Narrow.
The results suggest that unless stage management is required by a more severe fracture type or the presence of deep contamination, initial intramedullary narrowing is favored over stage intramedullary nailing as associated with improved clinical outcomes. But their study did not examine clinical equipoise in these cases.
So I think that that is a fundamentally questionable statement. They're putting their spin on it and their interpretation and probably yes, all things considered, it is going to be as they say. But this study itself did not show clinical equipoise in terms of.
And maybe that is some of exactly what they said they wanted to study. But I don't see that they actually presented that part of the study especially well, like, are they getting the delayed treatment because of either environmental, as in the culture at the place, concerns about contamination, or just technical skills or, you know, are some of these things perception or some of these things actionable and correctable, or are some of these things just baked into the milieu?
And so, you know, they found initial intramedullary narrowing was associated with improved PCs and MCS scores and, and significantly higher MRUST scores relative to stage and medullary neuron. That's exactly what the standard would be in the literature, given the observed difference in management between the results in this study and those reported from higher resource regions. Treatment timing and antibiotic administration represent areas of further investigation. I don't think it's further investigation. It's potential Areas for improvement as they also note. I mean, I guess you could investigate why it's not happening, but it essentially amounts to, you know, some, some process improvement. And, and this is a little bit, I think of a shell game paradigm because what they promised you was things are drastically different in these places and we have to understand we cannot. They're basically making the case you cannot use the literature that was developed in high income countries in these contexts because it doesn't apply. But yet the patient population, everything they found seems exactly to just apply.
[00:09:34] Speaker B: Right?
Yeah, all good points, I agree.
I thought one of the interesting things was there was a very small portion, as one would expect, of patients that were treated with definitive casting, but those patients actually had the highest functional outcome scores among all treatment groups for all Castelo Anderson types.
You might just hand wave and say, well, that was probably because they were lower grade injuries. But they state that it was not actually the case for this group, that they were actually not in the lower injury grade category, that the ones that were treated with definitive casting and they still did well. So maybe there's something to be said for casting.
[00:10:11] Speaker A: Well, I mean it really just comes down to that. Clinical, they're not studying clinical equipoise, they didn't do anything to address the confounding by indication or they're not even, you know, as we said, all this is conjecture because you're not sure exactly what were the clinical circumstances that allowed for the casting or why it was selected. Or you know, maybe these folks that are doing the casting, you know, they are so incredibly skilled at doing that that like, you know, they get, they're putting on the layers and really contouring it and they, they, they have the time and the expertise and the space to create a work of art in a cast that none of us could even come close to doing that. Right. But we don't know that. So that's the part. It's just like the whole thing is going on hold as far as I'm concerned. Like the premise. You, you told us a premise that you didn' Terms of what, like the substrate looks like. You said that like the outcomes were potentially different, but if the outcomes are the same, does that even like if your conclusions are just do what the high income literature is saying, why does that need to be published?
[00:11:17] Speaker B: Right?
[00:11:19] Speaker A: And then the parts that are really like, well, this could be interesting here and this could really be something that is seminal or unique to these environments that we'd understand better.
[00:11:27] Speaker B: They just gloss over that that would have been interesting. To drill down a little bit more on the cause. Very good.
[00:11:35] Speaker A: On hold.
[00:11:36] Speaker B: My paper is the Substantial clinical benefit after total Knee Arthroplasty has been set too high an analysis of the American Joint Replacement Registry by Zalika and Associates and there is a commentary.
This is a study from Stanford in conjunction with the Data Science Department of the AOS that evaluated the attainment of the minimally clinically important difference or MCID and substantial clinical benefit or SCB of patients who underwent primary total knee arthroplasty in the AJR or the American Joint replacement registry from 2018 to 2023. The premise of this study is a very important one as many arthroplasty surgeons know because of the increasing volume of joint replacement anticipated to grow from 401% from 2014 to 2024. The Centers for Medicare and Medicaid Services or CMS has targeted joint replacement in value based care programs, one of which is to mandate hospitals begin recording PROMS data for total knee arthroplasty in 2024 with the plans to report the proportion of patients achieving the SCB for the Knee Injury and Osteoarthritis Outcome score for joint replacement or the COOs Junior by 2027 which is part of the Transforming Episode accountability model aka its catchy acronym team, which will be mandatory episode based payment model running from 2026 to 2030 which ties payments to PROMS based benchmarks. Failure to report will result in hospital level penalties that will affect even non orthopedic claims with significant repercussions across hospital systems. The SCB threshold was set by Medicare and Medicaid or CMS at 20. The authors of this study indicate that they understand the threshold was selected by CMS based on interviews with patients.
The study screened the AAjRR database from 2018 to 2024 for patients aged 18 to 100 who underwent primary total knee arthroplasty with available COOs junior scores within 98 days pre op and one year post op or 300 to 525 days after surgery. The majority of patients were female, non Hispanic white race, BMI less than or equal to 34 with cemented fixation and no enabling technology.
The outcomes were attainment of the MCID or smallest change in score that a patient perceives as beneficial and set at 4.5, a literature based anchor based MCID of 14 and the SCD defined as a large change that a patient perceives as substantially improved.
The mean pre op cruise junior score was 49.37 and the mean post op score was 76.8. At one year, 86.8% had achieved the distribution based MCID, 76.5% had the literature derived MCID and only 65.7% achieved the SCB.
Factors associated with lower odds of achieving the SCB were those with higher pre OP scores Asian patients, black patients, Hispanic patients, male patients and those with higher bmi. A CCI or Charleston Comorbidity index of more than or equal to 5 was associated with lower odds of achieving the distribution based MCID and anchor based mcid.
The authors concluded that the CMS relatively arbitrarily defined the substantial clinical benefit at a value that is too high for an operation that routinely yields more than 80% patient satisfaction.
This study was methodologically sound in my opinion. There were a large number of patients as AJRR is the world's largest total joint arthroplasty registry on the basis of case volume with over 93.1% record agreement.
I thought the results of the analysis that considered demographic variables that were associated with lower likelihood of achieving the metrics which suggest patients that are ethnic and racial disparities exist, which is particularly relevant to the population I treat. So it was good that they looked at that. It was surprising that Asian patients had lower attainment of the MCID and scb, which does not reflect data in other POP data studies. It was a retrospective database study with its inherent limitations, namely that the survey response rate was only 5.4%, which may lead to bias for those that voluntarily fill out the surveys.
However, given the large sample size, it still leads to a meaningful number of patients sampled. Another limitation in my opinion is that the authors indicated that the rate of SCB attainment is low and therefore the threshold is set too high. I agree with that part, but they go on to say for an operation that usually leads more than 80% satisfaction.
However, that is a satisfaction level from four other papers in the literature that they quote and not the satisfaction of the patient sampled whose satisfaction we actually do not know.
In other words, this may be another case fitting for Donnie Brasco's famous quote bringing back some vintage. Your case is on hold references.
Translate it to satisfaction. Yeah, it's a beautiful thing, but it's not my thing.
We don't know for certain that these particular patients had 80% satisfaction, so they're extrapolating there. But any case, I do agree with the authors and the findings of this study. It was very impactful, not only for all of arthroplasty surgeons but for hospital systems as a Whole these metrics will imminently become publicly available and could be associated with significant penalties for hospitals and health systems. So I think it was a well done study. It was a study that needed to be done and for me it's not on hold.
[00:17:10] Speaker A: Yes. Okay. So I love the Donnie Brasco paradigm. Interesting slant on that front. I have a few thoughts. And this actually ties in. Not that long ago we discussed another payment reform health econometric study that I think has a lot of the same areas of intersection. So the first thing that I want to touch on the low hanging fruit here is, as you mentioned, this is a retrospective study done by authors, I believe, at Stanford with the American Joint Replacement Registry.
I don't see how this can be reconciled as level two evidence. It's a retrospective review of data imported to a registry by all sorts of surgeons in all sorts of places from 2018 to 2023. And as you mentioned, you know, there's, you know, some concerns about surveillance bias and who's responding to. So this is, I don't believe it is in any way correct to consider this level two evidence, certainly not for the question that they're posing. But their question is also kind of a, it's really more of a, of a claim, substantial clinical benefit after total knee arthroplasty has been set too high. They didn't study, they just told us, you know, within this registry, who, what were the factors associated with who met the SCB or the MCID in this area. That area, they didn't objectively study whether it is set too high or not.
So in a different paradigm, I think this is a Jackie Childs paradigm, which is essentially, we're going to do a study and whatever the study says, we'll just come back to our main unfounded premise, which is we don't like this. Right. You do see that a lot with these kind of econometric studies. There's a lot of nuance here that they didn't drill down on, particularly when it comes to, you know, out of everything.
I was surprised at how the patient background, race or ethnicity were almost uniformly drivers of lower likelihood, lower odds of the satisfactory outcome. And that should have probably been looked into more with some interaction analyses. You could have looked at interactions, you could see, you know, what, what is it that's, that's contributing to that? The higher preoperative scores, of course, make sense. The CCI of greater than equal to five definitely makes sense. And then this ties into the college tuition paradigm that I pitched on our last health econometrics study, which is all of these parameters are built around there's, they want them to be winners and losers. And for the, you got to set it somewhere. And where so many health reform efforts have been criticized as failing is that they tried to make it so that it was just as, as benign as possible. Like, you really had to be egregiously bad not to get the, the, you know, the incentive payment. And it was just basically like, well, just keep doing total knee arthroplasty or total joints, whatever it is, and you'll keep getting paid. Like. So their team is really designed to incentivize the performance in certain areas because again, at the end of the day, if it doesn't matter if the individual is coming with, you know, they're going to write you a check for $40,000 at the end of the case and then they can take all the risk. But when most of what's being paid is by Medicare that, you know, is having trouble with its fund, they want to set it so that they want the benchmark to be not that the patients are satisfied, that the patients are knocking it out of the park. And that's why you see, like, if it's, you know, they're not really that disabled, maybe they don't need the Tony right now if they've got a bunch of comorbidities. And you know, even if they, even if they think they have a good outcome, they're not functional and they're having all their associated health care costs. And again, don't at me, don't send emails complaining that I'm not sensitive to. I get the plight of the orthopedic surgeon and I get patient needs. I'm just explaining to you what, why this isn't going to move the needle from a health economic standpoint. Because the people who made these, they know this, this is not news to them. They're aware that where they, they said it exactly where they wanted it to be. And they've probably done a whole bunch of background game, you know, analysis to see, like, if we have it here, how many people are getting, if we have it here, how many people are getting. And they've probably said it where they think it's going to be the right number for them.
So they're not inadvertently hurting people who they know definitely will benefit, but they're also, again, doing what it's intended to do. The whole concept of team is to incentivize, I believe, more careful, more strategic patient selection.
[00:21:55] Speaker B: Right. But then don't you think in some Respect. That's going to put other patients at risk for access. Right. So the patients that have the CCI that is lower than 5, the patients that have the ethnic disparities, they're at higher risk of having lower numbers. And then surgeons are going to cherry pick and lemon drop and then that changes our whole.
[00:22:16] Speaker A: That's the problem.
[00:22:17] Speaker B: Indications. Yeah.
[00:22:19] Speaker A: Is that you cannot predict how humans will respond to these things and what they will do to try to. Yes. So all of that in the spine space. But I wrote a whole review article on the impact of worsening disparities in the setting of team. There's potential for all those things. It's fully correct. There's the potential for those things. If you adjust the SCB a little bit too as well, it's just going to be what's the size of the population that's affected.
[00:22:45] Speaker B: Right, Right.
Yeah. It makes it harder and harder. These value based metrics, you know, at only 50% they require. CMS requires 50% of patients to respond to in the registry, which is huge. Only less than 6% of patients were responders. You know, so it's very difficult to yield the data that they want.
[00:23:06] Speaker A: Right. And that's the other thing is how much administrative FTE effort on the part of non clinician or clinician staff is going to be expended to. You know, now it's like a study. When I have a study, we need the patients. So we're calling them up, the RA is sending them emails. The, you know, who knows, like people go into their house.
What do we got to do to get you to fill out this form?
[00:23:33] Speaker B: Yep. We gotta hand them.
[00:23:35] Speaker A: Yeah.
[00:23:36] Speaker B: Okay, so on hold or not on hold.
[00:23:40] Speaker A: The information is interesting and important like within the context of the paper itself.
I, and I agree, I understand where they're coming from. But in terms of like their actual claim, starting from the title, which isn't really a study question, it's just their advocacy that that part for me goes on hold.
[00:24:00] Speaker B: Yeah. It was a provocative title. Perhaps.
Okay, so now for our actual your case is on hold featurette.
One stage versus two stage exchange arthroplasty for periprosthetic joint infection. A prospective randomized trial by Ferring and associates. There is a commentary. This is the lead article. There's an infographic and it is permanently.
So this study was a prospective multicentered non inferiority RCT to compare two stage versus one stage revision for the treatment of chronic prosthetic joint infection.
The standard of care for chronic PGA of the hip and knee has been two stage revision. This is associated with considerable patient morbidity, mortality and cost. One stage revision has been emerging as a more effective approach and has been adopted earlier in Europe than it has in the us.
However, data is lacking with respect to performance of one stage approach because many studies thus far have been underpowered or excluded. Complex PGI patients with straining sinuses, comorbidities, resistant organisms and the like in this study 323 patients were randomized with 166 in the one stage group and 157 in the two stage group. Patients were excluded for prior revision culture negative infection or fungal infection immunosuppression soft tissue involvement precluding wound closure. Patients were classified According to the McPherson classification for PJI based on their host. The primary clinical outcome measure was defined as no recurrence of infection by the same organism or reinfection by a new organism. Clinical success was made on the basis of one no clinical failure or reinfection with the same new organism, 2 no reoperation for PJI and 3 no PGI related death.
Secondary outcomes included patient reported outcome measures. The study was appropriately powered. Diagnosis of PGI was consistent with the MSIS criteria and follow up was observed for the purposes of the study at one year but then they continued to observe the results at two years. Post op patients were randomized to two patient treatment arms and there was no blinding. The surgical procedure was consistent by using a double instrument setup and similar irrigation antibiotic protocols with a focus on complete synovectomy and removal of all infected tissue. To the best of their abilities. IV antibiotics were given until 24 hours postoperatively and if cultures were negative at that time, six months of oral antibiotics for chronic suppression were prescribed. If cultures at 24 hours were positive or final histology showed persistent acute inflammation. A total of six weeks of IV antibiotics and six months of oral antibiotics were prescribed.
Of the 323 patients who provided consent and were randomized, the loss to follow up rate was 88.6% at one year and 9.6% at two years.
Sixteen patients in the one stage group and nine patients in the two stage group died prior to the two year follow up.
The one stage group was statistically non inferior to the two stage group. The one year success rate for one stage was 98% while the one year success rate for the two stage was 92%.
A logistic regression was performed to determine the effects of the basis of host grade organism resistance and presence of draining sinus. After adjusting for these one stage had just under four times the odds of success for host grade and organism resistance and 3.5 times the odds of success for draining sinus that was in the one stage group.
Results at two years were similar to those at one years. With regard to the logistic regression, the authors were very candid about their limitations, namely the possibility of selection bias in the multicentered study and the unusually low rate of failure in both groups, which they recognize renders the data somewhat fragile.
For instance, if they had one more positive failure, one more failure in the one stage group, that would have changed the p value to 0.06 and would not have been significant.
They attribute this to the technical aspects of the surgery and focus on infection control. And they are very specific about how they did the surgical technique and how the surgeons did that across all sites.
I would add that the low rate of failure in both groups may be related to both groups having predominantly McPherson Class A, which is uncompromised patients in both groups. In one of the tables it shows that the majority of patients in both groups were actually lower risk patients.
You know, we still don't know how one stage would fare for infections with severe soft tissue loss. So none of these patients required flap coverage, although they did include patients with draining sinuses in both groups. But they had to be able to close it primarily and in the severely immunocompromised patients, you know, but this study does lend a lot of credence to the, you know, the use of this technique with using a one stage technique in cases with draining sinuses, resistant organisms and uncompromised hosts, which historically we did not know the data pertaining to one stage in these groups. I thought it was a very well conducted study. It checks all the boxes, it's randomized, it's prospective, it can't be blinded, for obvious reasons to patient and provider or surgeon multicentered. It's appropriately powered. It's level one evidence in its truest sense. I love seeing this kind of methodological rigor in arthroplasty patient and arthroplasty patient paper rather. And you know, I think for this, definitely a high level study and the authors should really be commended for their methodology.
What are your thoughts, Andrew?
[00:29:34] Speaker A: Yeah, overall I like the study. I thought it was well done. I think there are some points where they're a little bit over their skis in terms of probably needlessly trying to sell it for more than than what it is.
I detected that in a couple of points, some of which you brought up, others of which I would like to speak on here. The first thing is that in their sample size estimate, they assumed a PGI recurrence rate of 15% and they definitely did not hit that.
So while they met their sample enrollment numbers, those numbers were predicated on an infection rate that didn't materialize.
So they are underpowered for their primary outcome at the end of the day. And there's only so much you can do about that. I mean, they have low failures. That's a good thing. But from the standpoint of the science, we're talking about four in the one stage treatment over two years and 11. So that's just a total of 15.
You're trying to make determinations based off of 15 episodes. And you can see that in their ultimate confidence interval developed around the odds ratio that resulted from the regression. And that's something else I wanted to touch on.
So they stated that multi variable logistic regression analyses were planned.
And that just doesn't, I mean, I don't see how you could do, you don't usually do multi variable logistic regression analyses in randomized control trials. That's. And, and I don't see how they could be planned because those would be based around the failure rate, the event.
And even if they were at 15% and say got to like 45, that's not enough events to really support a robust multivariate. So I'm not sure what they were talking about there. And again, some of this is sometimes like, there's some reviewer who's like, well, they should have been doing multivariable analysis. So they have to say, okay, yeah, but it says it was planned.
I just don't really get that.
And they say that they wanted to look at comorbidities because they could affect results.
They classified each patient in accordance with the McPherson staging system. And then they say they accounted for such comorbidities in the regression analysis. And that's just not an accurate representation because accounting for implies multivariable. And they didn't do multivariable. What they did was they did three simple bivariate regressions for McPherson, host grade organism resistance and the presence of a draining sinus, all done separately. So those are just, that's just taking a chi square test and instead of just getting a p value for the failure rates, you're getting an odds ratio at 95% confidence interval. That's what it's using the regression for. You're not accounting for anything, you're not adjusting for anything. When we look at that resultant odds ratio, it's 3.22. But the confidence interval is an order of magnitude and difference, 1.0 to 10.38 and 1.0 is the null, so it includes the null. That wouldn't really be considered a significant finding. Also, it's incredibly imprecise.
An order of magnitude difference in the, in the confidence interval is, is, is quite striking. And again, it just comes down to the fact that they didn't have enough failures to really support a regression analysis that's somehow going to be informative going forward. They're confined to they, they did the best that they did, but they don't have to be talking about all they. It. It detracts from the elegance of the work when you start trying to do all these other things and telling people you accounted for this but you didn't account for it. And when we look at the characteristics, as you said, when we see patients significantly comp. You know, they said this is about. This is the same kind of thing that we come back to in the first study where they're like this. We have to do this study because we need to account for patients with significant comorbidities and draining sinuses. All these factors need to be considered. But it's just 39 patients with draining sinuses. It's just 11 patients that were significantly compromised medically. So it's a handful. But are you really, are these findings really robust around. Those are just a very small subset of the patients that you're including.
And more of your estimates and more of your findings are going to be driven by the 50% of the cohort that had no compromising factors or the 85% that didn't have a draining sinus at the, at the end.
I think that the results do support the statistical non inferiority of the one stage treatment versus the two stage treatment.
They say even in patients with comorbidities of draining sinus or a resistant organism. And again, I think that's a mischaracterization. What it should say is in a cohort that included patients with variation in comorbidities, sinus and resistance, they then say that stage one treatment should be strongly considered as the standard of care. I think that is also over their skis, you showed non inferiority. You didn't show that it's the standard of care. It didn't outperform the two stage treatment.
That part I think is they're being inappropriately incautious in their use of language on that front. For sure.
[00:35:28] Speaker B: Yeah, those are really good points.
I think from a clinical standpoint that is the apprehension we have as surgeons when we're encountering patients that are more complex medically, have resistant organisms, and have draining sinuses. That's our fear of doing this operation. So you're quite right. If they overstate their findings, then that could potentially be pretty detrimental. But yeah, those are really good points.
Now we'll get into our honorable mentions. The Honorable mentions this month's issue go to two Pediatrics studies. In this issue we have Femoral head perfusion varies widely following surgical reduction for infantile developmental dysplasia of the hip Preliminary findings from a prospective study of contrast enhanced ultrasound. This is by Kebbe and Associates. There is a commentary and it is permanently free.
This was a prospective study that sought to use contrast enhanced ultrasound to assess intraoperative changes in perfusion following surgical reduction for infantile DDH with the goal of predicting proximal femoral growth disturbance, which is the artist formerly known as osteonecrosis. It is thought that altered perfusion of the epiphysis, either from direct trauma to the vasculature or restriction of blood supply during compression of the femoral head, leads to ischemia and osteonecrosis. There were 34 patients. In mostly female patients, contrast enhanced ultrasound was performed before and after surgical reduction in spicy casting in infants age 418 months old.
Delta projections were used to quantify and analyze changes in perfusion.
A lower perfusion index was seen in the majority of hips following reduction.
The most significant decrease in perfusion index was observed in the central region of the femoral head epiphysis. There was a moderately positive correlation between BMI and post reduction change in perfusion index. I thought it was interesting that there was a range of BMI in the age group of 4 months to 18 months old and that there was enough to have a correlation, but interesting study.
The next one was Predictive factors for fast healing following surgery of knee osteochondritis desiccants by Sigel. There is a commentary and a visual summary. This study is a prospective cohort study of knee OCD lesions in a multicenter database. The authors sought to develop an algorithm to predict the speed of OCD radiographic ossification based on patient demographics, physical and surgical and imaging data. Radiographic healing was defined on the basis of the percentage of the original OCD lesion that had normal bone density compared with the surrounding condyle rated on a continuous scale from 0 to 100, a lesion that achieved more than or equal to 90% of the normal surrounding bone density at 6 months following surgery was defined as a fast healing lesion.
The study had 79 lesions in 72 patients. The mean age was 13 years and 29% of lesions were found to be fast healing. A multivariable regression analysis revealed that high pre op bone density within the lesion was the only feature that predicted fast healing.
Lesions with a preoperative density of greater than or equal to 70% was predictive of fast healing with a sensitivity of 87% and a specificity of 66.1%.
So there you have it. Thank you for listening. If you like what you heard, please hit like and subscribe and give us a five star review.
Tune in next time where Andrew, our methodology guru, will lead us as we delve into the next Hot off the Press's article in JBJS Be in August. That's right.
