Plantar Fascii,s Treatment with Par,culate Human Umbilical Cord/ Amnio,c Membrane

Transcription

1 Plantar Fascii,s Treatment with Par,culate Human Umbilical Cord/ Amnio,c Membrane 1 David N. Garras, MD 2 Ryan T. ScoG, DPM 1 Midwest Orthopaedic Consultants, Asst. Professor, UIC, Chicago, IL 2 The CORE Ins,tute, Phoenix, AZ

2 Disclosures Both Authors received study materials and product for the purpose of conduc,ng this study. No monetary benefits were received by either authors.

3 Plantar Fascii,s Most common cause of heel pain affec,ng ~1 million pa,ents/year 1 Repe,,ve trauma resul,ng in degenera,on of the plantar fascia 2 Conserva,ve therapies are ineffec,ve in approximately 10-15% of pa,ents 3,4 Ortho,cs, stretching, night splint, NSAIDs Persistent conserva,ve therapy failure necessitates more invasive treatments, however, these therapies can be associated with significant clinical side effects and/or limita,ons 5 Injec,ons Cor,costeroids Plantar fascia rupture PRP Minimal clinical data Surgery biomechanical instability, post- op pain

4 Amnio,c Membrane / Umbilical Cord (AM/UC) Placental,ssues Immunomodula,on of local environment Decrease local inflamma,on an,- inflammatory signaling pro- inflammatory signaling AM/UC Mediated by unique extracellular matrix biology 7 HC- HA/PTX3 Matrix Complex Promotes a regenera,ve healing environment HC- HA/PTX3 Tissue Regenera,on

5 Case Series Design 60 pa,ents (n = 10/treatment) 25 mg AM/UC 2 injec,on 50 mg AM/UC 2 injec,on 100 mg AM/UC 2 injec,on Visit Schedule Baseline, 6, 12, 18 weeks Ultrasound- guided of micronized AM/UC,ssue (CLARIX FLO, Amniox Medical, Inc., Atlanta, GA) at baseline and 6 weeks (2 injec,on groups) Outcome Measures FAAM, Foot pain

6 Results N = 53 pa,ents completed 18 weeks follow- up >50% of pa,ents had pain of longer than 6 month dura,on and had failed conserva,ve therapies # Pa%ents 25 mg 1 injec%on 25 mg 2 injec%ons 50 mg 1 injec%on 50 mg 2 injec%ons 100 mg 1 injec%on Foot and Ankle Ability Measure (FAAM) completed at all visits Foot pain reported at all visits 100 mg 2 injec%ons

7 Results Foot Pain Mean Pain Score Injec,on 2 Injec,ons Mean Pain Score All treatments showed sta,s,cally significant reduced foot pain for the 18 week study period. For both and 2, 100 mg AM/UC,ssue demonstrated the greatest reduc,on in foot pain Pain Reduc,on 25 mg 25 mg 2 50 mg 1 injec,on 50 mg mg 100 mg 2 57% 66% 68% 60% 73% 70%

8 Results FAAM Ac,vi,es of Daily Living Mean FAAM- ADL Score Injec,on 2 Injec,ons Mean FAAM- ADL Score For both and 2, 100 mg AM/UC,ssue demonstrated the highest FAAM- ADL scores at 18 weeks FAAM % Change 25 mg 25 mg 2 50 mg 1 injec,on 50 mg mg 1 injec,on 100 mg 2 48% 135% 49% 72% 71% 102%

9 Results FAAM Sports 1 Injec,on 2 Injec,ons 9 8 Mean FAAM- Sports Score Mean FAAM- Sports Score All treatment groups demonstrated an increase in the FAAM- Sports subscale. In pa,ents receiving two, there was a dose dependent increase the FAAM- Sports score at 18 weeks FAAM % Change 25 mg 25 mg 2 50 mg 1 injec,on 50 mg mg 1 injec,on 100 mg 2 176% 420% 102% 395% 377% 107%

10 Conclusion Injec,ons of micronized human amnio,c membrane/ umbilical cord (AM/UC),ssue: Significantly decreased pain from baseline Significantly improved overall func,onal recovery from baseline (with the excep,on of 25mg/) Despite low overall pa,ent numbers: Dose dependent trend in AM/UC efficacy (100 mg > 50 mg > 25 mg) Injec,on dependent trend (2 > ) Results are consistent with an earlier study 5 : Injec,on of micronized AM,ssue improved pa,ent outcomes similar to steroid injec,on Overall, these results are promising and highlight the poten4al effec4veness of AM/UC 4ssues as a treatment for plantar fascii4s

11 References 1. Goff JD, Crawford R. Diagnosis and treatment of plantar fascii,s. Am Fam Physician. 2011;84(6): Mahowald S, Legge BS, Grady JF. J Am Podiatr Med Assoc. 2011;101(5): Thomas JL, Christensen JC, Kravitz SR, et al.; American College of Foot and Ankle Surgeons Heel Pain CommiGee. The diagnosis and treatment of heel pain: a clinical prac,ce guideline- revision J Foot Ankle Surg. 2010;49(3 suppl):s1 S19 4. Donley BG, Moore T, Sferra J, Gozdanovic J, Smith R. The efficacy of oral nonsteroidal an,- inflammatory medica,on (NSAID) in the treatment of plantar fascii,s: a randomized, prospec,ve, placebo- controlled study. Foot Ankle Int. 2007;28(1): Hanselman AE, Tidwell JE, Santrock RD. Cryopreserved human amnio,c membrane injec,on for plantar fascii,s: a randomized, controlled, double- blind pilot study. Foot Ankle Int Feb;36(2): He H, Li W, Tseng DY, et al. Biochemical characteriza,on and func,on of complexes formed by hyaluronan and the heavy chains of inter- alpha- inhibitor (HC*HA) purified from extracts of human amnio,c membrane. J Biol Chem. 2009;284(30): Tseng SC. HC- HA/PTX3 Purified From Amnio,c Membrane as Novel Regenera,ve Matrix: Insight Into Rela,onship Between Inflamma,on and Regenera,on. Invest Ophthalmol Vis Sci. 2016;57(5):ORSFh1-8