In any one direction. If we waited to get to 110 subjects w randomization- study would have taken 10 years- even w 12 centers. I plan on being retired on a beach by then... #eastjc
This of course comes at the expense of potential bias, we we did not find any differences between those who selected surgery and those who didn’t. We showed every subject a standard video explaining that there was no proven benefit to surgery, and had house staff #eastjc
Including an observational arm allowed us to accrue subjects relatively quickly, thereby minimizing other changes in practice over the study timeline, and maintaining enthusiasm. #eastjc
Yes interesting is one word for it! we expected a high rate of refusing randomization- and in fact it was 80%. People (understandably) just weren’t willing to accept a random decision to get an operation. - #eastjc
@FredricPieracci VATS fixation
The impact of VATS is minimal, I get significant number of my elective vats lobectomy home on day 1 and the majority by day2-3 so it adds less stress than the current incision I’m making for SSRF in addition to the benefit of htx drainage and nerve blockade
#eastjc
I would be very interested in others’ thoughts on what the next RCT in the non-flail population should look like. In NON-FLAIL, we use three or more displaced fractures with respiratory compromise but not intubated. Surgery within 72 hours. #eastjc
@FredricPieracci#eastjc are you planning on a long term >60 mo patient center outcomes study? for those who return to work doing physical activity SSRF may provide a benefit. Thoughts @EAST_TRAUMA@CWISociety
We thought it was important to have an outpatient outcome as primary, because we knew we were studying a less severely injured group and inpatient outcomes like mortality and ventilator days would be much more rare versus the flower trials. But, we knew follow up would . #eastjc
We are actually doing a single center RCT in Denver of Pain catheter versus one time liposomal bupivacaine injection in the OR during SSRF. 31/45 subjects enrolled. I think there will be some power issues. This kind of question would be great for a multi center study.#eastjc
Be an issue. So we compromised on two weeks. Pain scores and quality-of-life were improved in the operative arm. Unfortunately narcotics did not reach significance(the dreaded p=0.05), But we still saw a strong signal out to eight week follow up. #eastjc