Journal Club #2

[ldsrmdude]

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I think that the last journal club we did about neuromas was very interesting and some excellent discussion and debate was had. I'd like to have these on a somewhat regular basis, so I'm thinking we should start finding some articles for our next one. If you have read an interesting article that you think would be good to discuss, post a pubmed link to it. We'll choose an article to discuss sometime probably next week. Try to keep the articles relatively recent. Any attendings, residents, students, pre-pods who want to contribute should feel free. If there are any questions, feel free to PM myself or pacpod.

 

[JR2011]

J Bone Joint Surg Am. 2013 Jul 17;95(14):1312-6. doi: 10.2106/JBJS.L.01529.

Quantitative assessment of the yield of osteoblastic connective tissue progenitors in bone marrow aspirate from the iliac crest, tibia, and calcaneus.

Hyer CF, Berlet GC, Bussewitz BW, Hankins T, Ziegler HL, Philbin TM.

 

[ldsrmdude]

Great articles so far. Any other articles we should have on our list? We'll give it a few more days and pick one to discuss.

 

[ldsrmdude]

Ok, we've decided to discuss one of the articles AnkleBreaker suggested:

Correction of intermetatarsal angle in hallux valgus using small suture button device.
Holmes GB Jr, Hsu AR.
Foot Ankle Int. 2013 Apr;34(4):543-9. doi: 10.1177/1071100713477628.
PMID: 23559614 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/23559614

We'll start our discussion thread about it with AnkleBreaker giving us a synopsis to kick it off. We'll put the thread together in a few days so everyone can have a chance to read the article before we discuss it.

 

[JR2011]

K I'll go first:

Authors are to be congratulated on taking the time and effort to to publish research. Performing and publishing your own research is time consuming and takes a lot of work.

Interesting that the IM angle continued to decrease with time. If they manually reduced the IM angle, it seems that the correction should have been done immediately post op, but that is not what the results show.

As far as being critical:
Suture buttons have been shown in previous studies to have relatively high complication rate when used for HAV. The study listed in the link found a 32% rate of 2nd met stress fracture rate in 25 patients. Furthermore, the indication the authors advocate is for elderly pts in which osteotomies and fusions may have higher complication rate. Elderly clearly have poorer bone stock and are at increased risk of stress fracture.
http://www.ncbi.nlm.nih.gov/pubmed/23386769

6 month follow up is too short and they only had 14 cases (Level IV). I'd be willing to bet if you followed these osteoporotic patients down the road, at 1 year you would identify some number of met stress fractures. This is enough for me right now to NEVER consider using it. Still the research tells you something.

I think the literature is enough to tell me I will only use this device for Syndesmotic fixation as the literature at this point favors the use. I will not use it for bunion deformity.

I am clearly not the thread starter or leader here but I would suggest: As far as literature, I think it is beneficial to pick high level of evidence studies if we are taking the time to review it and I am biased towards quality podiatric literature as it is our own.

 

[JR2011]

So my conclusions about this article go like this:

Small population used with primarily healthy subjects. An interesting study and an interesting concept. Hopefully more studies will be done utilizing more complicated patients to see if this device would work. To avoid doing any osteotomy cuts in patients with an increased potential to have poor bone healing would be a pretty big feat in bunion correction.

It's important to note that other studies have used the mini tight rope device but they used 2.7 drill bits to make their holes. It is believed this is why stress risers and fractures occurred in the 2nd metatarsals. This study utilized a 1.1 drill bit and buttress plate to stabilize the holes in the second met. This could be the modification that was needed to successfully do this procedure.

If we review the results table in the attached word document you will notice a "rebound" increase in HAV and IM angles from 1 week post-op to 3 months post-op. This is a not a failure of the device but rather the x-rays taken at 1 week post-op were NON-WB where the x-rays taken at 3 months post-op were WB. Thus increase plantar pressures will spread the bones apart and cause this increase angulation in the HAV and IM angles.

The patients were divided into two groups. 8 subjects had symptomatic HAV with an IM angle of 8-12 degrees where 6 patients had symptomatic HAV with IM angles from 13-20 degrees. Both groups experienced this "rebound" increase in angulation in the HAV and IM angles from 1 week post-op to 3 months post-op. BUT at 6 months post-op it appears group 2 is starting to lose it's reduction where group 1 sustains its reduction at 6 months post-op. Being that the study only goes to 6 months post-op really does the reader a disservice because although group 1's reduction appears to be stable I am curious to know if the reduction in group 2 decreases further at 9 months, 1 year, and so on. That's probably the biggest weakness of this study.

So what do we take away from this study:

1. We know that the modification in this study's procedure will most likely decrease the chance of second metatarsal fracture in healthy subjects.
2. Healthy individuals with symptomatic HAV with IM angles any where from 8-12 could probably be served pretty well with this procedure
3. It's possible individuals who are more complicated (osteoporosis, chronic smoker, renal osteodystrophy, etc) could be served by this procedure with the above stated modifications. More studies need to be done utilizing these complicated patients so we have a better idea of what the true indications of this device are.

^ Like not level IV studies 14 HEALTHY patients?

Just joking. Incredibly thought provoking sure. Literature is enough at this point to discredit its use in HAV in my opinion. My healthy patients are getting more definitive procedures without experimental implantations with off label use.

Love journal club, but more quality studies would yield more definitive conclusions and impact clinical/surgical decision making. Its wise to support podiatric literature when possible.

 

[ldsrmdude]

A few random thoughts on the article. First off, as noted in AnkleBreakers synopsis, the author is the inventor of this procedure, and stands to benefit significantly from this procedure doing well and being utilized. That makes me wary right off the bat. As mentioned, the short follow-up is a concern as is the seeming loss of correction in the higher IMA group at 6 months. If I was going based just on this article, that would preclude its use in anything above an IMA of 12. I would be concerned utilizing this procedure on patients with many comorbidities. In this study, one of the complications was an intraoperative 2nd metatarsal fracture during tightening of the device. This occurred in a patient with osteoporosis, which concerns me if I'm thinking about using this in patients with osteoporosis/osteopenia.

Overall, I'm not sure I see any reason to do this procedure when there are other procedures that offer proven results, don't make the patient be non-weightbearing for 2 weeks, and costs probably 20 times as much as a couple of 2.7 screws. In a lot of ways, it seems like an answer in search of a problem, which, given the fact that the author is the inventor of the procedure and would benefit from it gaining in popularity, very well could be the case. It's an interesting article, and I hope that some others chime in on what they thought about it.

 

[dtrack22]

it seems like an answer in search of a problem,

This. The article screamed podiatry. I'm sure we aren't the only specialty that does this, but a lot of our literature seems to focus on "problems" that don't exist. I'm all for advancing surgical techniqes, but using a tightrope to fix a bunion seems unnecessary (and ineffective). Remember, we used to successfully fix bunions by simply jamming the capital fragment back on to the metatarsal. One day I will invent a 3 screw fixation technique for bunions called the extra-long dorsal arm chevron osteotomy...because if 1 point of fixation is sufficient and 2 is better, then 3 must be best

I should do more research on tight ropes for syndesomtic injuries, but it seems the biggest proponents in our literature are guys who consult for arthrex. The couple of studies I've read were flawed and from what I've seen as a student, I wouldn't grab a tight rope off of the shelf in place of a screw. Maybe in an isolated syndesmotic injury? But what's the rate of those injuries among all ankle fx?

 

[JR2011]

Overall, I'm not sure I see any reason to do this procedure when there are other procedures that offer proven results, don't make the patient be non-weightbearing for 2 weeks, and costs probably 20 times as much as a couple of 2.7 screws. In a lot of ways, it seems like an answer in search of a problem, which, given the fact that the author is the inventor of the procedure and would benefit from it gaining in popularity, very well could be the case. It's an interesting article, and I hope that some others chime in on what they thought about it.

^ This. Totally agree.

This. The article screamed podiatry. I'm sure we aren't the only specialty that does this, but a lot of our literature seems to focus on "problems" that don't exist. I'm all for advancing surgical techniqes, but using a tightrope to fix a bunion seems unnecessary (and ineffective). Remember, we used to successfully fix bunions by simply jamming the capital fragment back on to the metatarsal. One day I will invent a 3 screw fixation technique for bunions called the extra-long dorsal arm chevron osteotomy...because if 1 point of fixation is sufficient and 2 is better, then 3 must be best


Also agree. Well said. Its kind of reinventing the wheel, which the professiona has a tendency of revisiting old school techniques with a new industry driven spin.

I should do more research on tight ropes for syndesomtic injuries, but it seems the biggest proponents in our literature are guys who consult for arthrex. The couple of studies I've read were flawed and from what I've seen as a student, I wouldn't grab a tight rope off of the shelf in place of a screw. Maybe in an isolated syndesmotic injury? But what's the rate of those injuries among all ankle fx?[/QUOTE]

I haven't paid as much attention to the conflict of interest portion of these studies but they have all been favorable outcomes for most part, with removal rate less than 25%. Done about 12 and have been very happy with outcome, several were for gross syndesmotic ruptures with high fibula fractures. I think Cottom's and Hyers original study is still one of the best out there on this, not to mention the first.

http://www.ncbi.nlm.nih.gov/pubmed/18752774

http://www.ncbi.nlm.nih.gov/pubmed/19857816

http://www.ncbi.nlm.nih.gov/pubmed/23770192

 

[dtrack22]

Cottom

Right. And maybe this isn't fair but Cottom = arthrex to me. I have a hard time when I see papers about tightropes, swivelock, and corkscrew anchors. His inside out brostrom is interesting (and possibly effective/efficient if you can do it as fast as he can), but has industry written all over it.

Somebody has to front the money and a well designed study should stand on its own, regardless of who's paying for it. But I tend to be overly critical of studies that include arthrex products with his name on it.

Thanks for the links!

 

[JR2011]

Right. And maybe this isn't fair but Cottom = arthrex to me. I have a hard time when I see papers about tightropes, swivelock, and corkscrew anchors. His inside out brostrom is interesting (and possibly effective/efficient if you can do it as fast as he can), but has industry written all over it.

Somebody has to front the money and a well designed study should stand on its own, regardless of who's paying for it. But I tend to be overly critical of studies that include arthrex products with his name on it.

Thanks for the links!

You make a solid point, and much of it could very well be industry driven which is unfortunate in research.

I guess the way I look at cottom's work, which is fully my outside opinion, as he did the original research for the new product, and published it, the area is kind of his "baby". As he has continued his research on the topic with long term follow up, he wants to remain as the leader in this area. I know if it was my baby I'd want to keep the studies going with it.

 

[ldsrmdude]

This. The article screamed podiatry.

I'm sure Dr. Holmes, an MD, feels thoroughly insulted by this comment 😀

 

[dtrack22]

I'm sure Dr. Holmes, an MD, feels thoroughly insulted by this comment 😀

Maybe he should. It was very Poe-diatry of him.

And why are we discussing a case series from the creator of the product under investigation? There were some other good articles posted above...

 

[JR2011]

Maybe he should. It was very Poe-diatry of him.

And why are we discussing a case series from the creator of the product under investigation? There were some other good articles posted above...

^ THIS

I'd go as far to say this has turned into a TFP discussion.

 

[ldsrmdude]

Fine lets do another. Pick another article from above and I will present. Or you can do the honors.

Sounds like a plan to me. Since JR2011 offered up an article in the beginning of this thread, maybe he wants to discuss that one. Dtrack can feel free to pick another article and we can discuss a couple of articles at the same time. If we have a couple of article discussions going at the same time, it might be easier to have separate threads so it's not too confusing.

 

[JR2011]

Sounds like a plan to me. Since JR2011 offered up an article in the beginning of this thread, maybe he wants to discuss that one. Dtrack can feel free to pick another article and we can discuss a couple of articles at the same time. If we have a couple of article discussions going at the same time, it might be easier to have separate threads so it's not too confusing.

BACKGROUND:

It is well known that bone marrow aspirate from the iliac crest contains osteoblastic connective tissue progenitor cells. Alternative harvest sites in foot and ankle surgery include the distal aspect of the tibia and the calcaneus. To our knowledge, no previous studies have characterized the quality of bone marrow aspirate obtained from these alternative sites and compared the results with those of aspirate from the iliac crest. The goal of this study was to determine which anatomic location yields the highest number of osteoblastic progenitor cells.

METHODS:

Forty patients were prospectively enrolled in the study, and separate bone marrow aspirate samples were harvested from the ipsilateral anterior iliac crest, distal tibial metaphysis, and calcaneal body. The aspirate was centrifuged to obtain a concentrate of nucleated cells, which were plated and grown in cell culture. Colonies that stained positive for alkaline phosphatase were counted to estimate the number of osteoblastic progenitor cells in the initial sample. The anatomic locations were compared. Clinical parameters (including sex, age, tobacco use, body mass index, and diabetes) were assessed as possible predictors of osteoblastic progenitor cell yield.

RESULTS:

Osteoblastic progenitor cells were found at each anatomic location. Bone marrow aspirate collected from the iliac crest had a higher mean concentration of osteoblastic progenitor cells compared with the distal aspect of the tibia or the calcaneus (p < 0.0001). There was no significant difference in concentration between the tibia and the calcaneus (p = 0.063). Age, sex, tobacco use, and diabetes were not predictive of osteoblastic progenitor cell yield.

CONCLUSIONS:

Osteoblastic progenitor cells are available in the iliac crest, proximal aspect of the tibia, and calcaneus. However, the iliac crest provided the highest yield of osteoblastic progenitor cells.

CLINICAL RELEVANCE:

The study demonstrated that osteogenic progenitor cells are available in bone marrow aspirate harvested from the tibia or calcaneus as well as the iliac crest. All three sites are easily accessed, with a low risk of adverse events. However, larger volumes of aspirate may be needed from the tibia or calcaneus to approach the yield of cells from the iliac crest.
_____________________________________________________________________________________________________________________



One of the best studies I have read in awhile. Hyer does great work for our profession IMO. Iliac crest showed about 13 Stem Cells/ mL which was significantly more than the Calcaneus and Distal tibia which was around 5.

I don't think its surprising that the iliac crest had the highest number of stem cells but now it has actually been quantified at different anatomic locations. I think the fact that they chose calcaneus and Distal tibia is important as most Podiatric foot and ankle surgeons would be comfortable harvesting from these sites.

One thing of note, is that they only drew 10 mL's per site for analysis. We routinely utilize proximal tibia Bone marrow aspiration with standard BMA trocar kit. We aim for 30 mL's which are then centrifuged down to yield cell line of interest. SO, even though Iliac crest has most cells, you can still get a good number of cells by obtaining more aspirated.

I'd love to see how Proximal Tibia aspirate compares to Distal tibia aspirate.

Also very interesting findings were that no difference in cell numbers were found with comorbid conditions such as Diabetes or smokers. Thus, the obvious impact of these has impact elsewhere on cellular transduction or cell function rather than number of Progenitor cells.

Either way, it is clear that stem cells have very beneficial influence in complex foot and ankle arthrodesis procedures. I believe this article made a serious step in this area for the field and it will be a building block for further studies of this type.

THANKS FOR PICKING MY ARTICLE 😉

 

[ldsrmdude]

Here is the pubmed link to JR2011s article for those that want to look at it:

http://www.ncbi.nlm.nih.gov/pubmed/23864180

I would encourage everyone to take a chance to read the article and post your thoughts. 👍

 

[ldsrmdude]

As you mentioned JR2011, Hyer does great work and has made huge strides for our profession, both with his research and simply for the fact that the fellowship he co-directs has DPM and MD/DO fellows that are held to the same standards and is AOFAS and ACFAS approved. In terms of the article, it's another solid article from Hyers group. It quantifies something that many of us use (BMA from distal tibia and calcaneus) and as you point out, it sets up future studies.

 

[JR2011]

As you mentioned JR2011, Hyer does great work and has made huge strides for our profession, both with his research and simply for the fact that the fellowship he co-directs has DPM and MD/DO fellows that are held to the same standards and is AOFAS and ACFAS approved. In terms of the article, it's another solid article from Hyers group. It quantifies something that many of us use (BMA from distal tibia and calcaneus) and as you point out, it sets up future studies.

👍