As anyone who has published medical papers knows….it can be a long run! 10 months after submission, we are finally at the finish line for our paper evaluating the average level of evidence in 6 of the top 10 orthopedic surgery journals. Summary: 13 months of journal articles evaluated, 1425 papers evaluated…..average level of evidence? 3! Although the gold standard is the randomized blinded controlled clinical trial…..in actuality the most practical study format for a surgical discipline like orthopedics appears to be level 3 (non randomized trials or retrospective cohort studies for example)
This will be published in the Biologic Orthopedic Journal!
I am paraphrasing the questions but the content is accurate. Question #1 “Can a clinician use adipose (SVF) or microfat (ala Lipogems) in a knee joint or for tendinopathy?”
Answer #1 No
Question #2 “Can a clinician use fat without manipulation, other than rinsing, in a remote location for cushioning?”
Answer #2 Maybe
I have friends using adipose and gathering data and doing research. It is important research that needs to be done if we going to get IND/BLA and ultimate FDA approval for this orthobiologic for typical orthopedic pathologies. RIght now, I worry about the medico-legal risk of using an unapproved biologic drug….even if the FDA isn’t stopping me…the plaintiff’s attorney could come after me and I am not sure if my malpractice would cover my use of an unapproved biologic drug per the FDA Director of CBER.
Even Low Dose PRP is as good or better than a steroid shot!
There is a new level 1 study the the Journal of Arthroscopy comparing steroid and PRP injections for partial thickness rotator cuff tears.
Results? At 3 months patients receiving PRP injection had significantly better function and pain relief. However at 1 year there was no difference between the two groups.
The PRP was made with Regenlabs in which 10cc of blood is made into 5.5cc of PRP. The PRP concentration is only 1.6x. Typically I draw 60cc of blood to make the same 5.5 cc of PRP so the concentration is nearly 6 times higher than Regenlabs.
Additionally, I still feel it is important to quantify EVERY PRP dose with whole blood and PRP analysis on a validated hematology machine at the point of care. Every patient gets a whole blood AND PRP eval with WBC with diff., RBC, and Platelet count. PRP with 6x the platelet and growth factor dose might show that PRP’s benefit is even better! There should be no additional cost to the patient of drawing 60cc versus 10cc of their own blood.
I commend Ian Lo, MD and his team on this work and showing that even a low dose PRP orthobiologic treatment is safe and at least as effective as a steroid treatment. We need more work like this!
Our channel is a mix of live arthroscopic video, orthobiologics, MSK ultrasound videos, and seminars and talks given at orthopedic and orthobiologics meetings.
We have a few exciting ideas and projects that will be released this month…stay tuned!
If you come across any “stem cell seminars” that sound too good to be true….
Or if you are told that the stem cells will come from a place other than your own body (amniotic fluid, umbilical cord blood, etc.)
Or if you have been told that stem cells can be used for autism, alzheimers, parkinson’s, strokes, lung disease, diabetes, lyme disease, anti-aging, eye disease, kidney disease, etc in the USA without FDA oversight
Or if you have been told about the FDA approved “wonders” of exosomes in humans……we want to know about it!