AAOS: American Academy of Orthopaedic Surgeons; AOFAS: American Orthopaedic Foot and Ankle Society; CHI: Catholic Health Initiatives.

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1 Mdical Policy CLINICAL INPUT RESPONSES AAOS: Amrican Acadmy of Orthopadic Surgons; AOFAS: Amrican Orthopadic Foot and Ankl Socity; CHI: Catholic Halth Initiativs. Additional Commnts Ankl Ostochondral autografts ar appropriat for primary tratmnt of ostochondral lsions of th talus with a surfac ara > 150mm 2. (AAOS/AOFAS) Both ostochondral autograft and allograft transplantations ar valid tratmnt options in rvision situations. (AAOS/AOFAS)

2 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions Ostochondral allografts hav bn shown to b usful for primary tratmnt of larg, cystic ostochondral lsions of th talus. In larg cystic lsions, as dfind by surfac ara >150mm 2 or volum >3000mm 3, arthroscopic marrow stimulation tchniqus ar unrliabl and obtaining an adquat volum of autograft carris th risk of significant morbidity. (AAOS/AOFAS) Whil th us of autograft has a trnd for suprior rsults for graft haling, donor sit morbidity with chronic kn pain can b a caus of concrn ranging from 0-26% of patints. Howvr, ostochondral frsh allograft may b th only option in crtain cass with xtraordinary larg lsions or whn th lsions involv shouldr rgion of th talus. Ovrall, both ostochondral autograft and allograft transplantation hav a dfinitiv rol in th tratmnt of uncommon but disabling rcurrnt ostochondral lsions of th talus. (AAOS/AOFAS) An attmpt to trat a patint with an ostochondral autograft givs patints an opportunity to dcras pain and improv function and avoid a potntially gratr morbid procdur such as a fusion or total ankl arthroplasty, which may b inappropriat in a youngr patint. (Anonymous - CHI) Elbow Larg OCD [ostochondritis disscans] lsions of th capitllum may bnfit from ostochondral autografts in patints failing nonoprativ tratmnt or dbridmnt/microfractur. (Anonymous - CHI) S Appndics 1 and 2 for dtails of th clinical input. Original Policy Dat: August 2001 Pag: 2

3 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions APPENDIX APPENDIX 1. CLINICAL INPUT RESPONDENTS Appndix Tabl 1. Rspondnt Profil Spcialty Socity No. Nam of Organization Clinical Spcialty 1 Amrican Acadmy of Orthopadic Surgons / Amrican Orthopadic Foot Orthopadics, Foot and Ankl and Ankl Socity Physician No. Nam Dgr Nam of Organization Clinical Spcialty Board Crtification and Fllowship Training Idntifid by Catholic Halth Initiativs 2 Anonymous MD Orthopadic Surgry Amrican Board of Orthopadic Surgry rcrtifid 2014, Sports Mdicin Appndix Tabl 2. Rspondnt Conflict of Intrst Disclosur No. 1. Rsarch support rlatd to th topic whr clinical input is bing sought 2. Positions, paid or unpaid, rlatd to th topic whr clinical input is bing sought 3. Rportabl, mor than $1,000, halth car rlatd assts or sourcs of incom for myslf, my spous, or my dpndnt childrn rlatd to th topic whr clinical input is bing sought 4. Rportabl, mor than $350, gifts or travl rimbursmnts for myslf, my spous, or my dpndnt childrn rlatd to th topic whr clinical input is bing sought Explanation Ys/No Explanation Ys/No Explanation Ys/No Explanation Ys/N o 1 No No No No 2 No No No No Individual physician rspondnts answrd at individual lvl. Spcialty Socity rspondnts providd aggrgat information that may b rlvant to th group of clinicians who providd input to th Socity-lvl rspons. Original Policy Dat: August 2001 Pag: 3

4 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions APPENDIX 2. CLINICAL INPUT RESPONSES Objctiv Clinical input is sought to dtrmin whthr us of ostochondral autografts improvs halth outcoms whn usd to trat focal articular cartilag lsions in th ankl and lbow. Elbow 1. For patints with focal articular cartilag injury of th lbow (g, ostochondritis disscans), ar thr clinical factors whr tratmnt with ostochondral autografts would b appropriat? No. Ys/No Explanation 1 No input availabl 2 Ys Larg OCD lsions of th capitllum may bnfit from ostochondral autografts in patints failing non-oprativ tratmnt or dbridmnt/microfractur. 2. For ach situation you dscribd in Qustion 1: a. Plas fill in th first column of th tabl blow with ach indication you rportd. b. Plas rspond YES or NO whthr th us of ostochondral autografts for patints with focal articular cartilag injury of th lbow (g, ostochondritis disscans) would b xpctd to improv halth outcoms. c. Plas us th 1 to 5 scal outlind blow to indicat your lvl of confidnc that thr is adquat vidnc that supports your conclusions. No. Fill in th blanks blow with ach indication you rportd in Qustion 1 Ys/No Low Confidnc Intrmdiat Confidnc No input availabl 2 Nonoprativ tratmnt failur Ys X 2 Faild dbridmnt Ys X 2 Faild microfractur Ys X 3. For ach situation you dscribd in Qustion 1: a. Plas fill in th first column of th tabl blow with ach indication you rportd. b. Plas rspond YES or NO whthr this clinical us is in accordanc with gnrally accptd mdical practic. c. Plas us th 1 to 5 scal outlind blow to indicat your lvl of confidnc that this clinical us is in accordanc with gnrally accptd mdical practic. High Confidnc Original Policy Dat: August 2001 Pag: 4

5 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions No. Fill in th blanks blow with ach indication you rportd in Qustion 1 Ys/No Intrmdiat Low Confidnc Confidnc No input availabl 2 Nonoprativ tratmnt failur Ys X 2 Faild dbridmnt Ys X 2 Faild microfractur Ys X High Confidnc 4. Additional commnts and/or any citations supporting your clinical input on th clinical us of ostochondral autografts for patints with focal articular cartilag injury of th lbow. No. Additional Commnts 1 No input availabl 2 Ostochondral autografts for OCD lsions of th lbow can provid symptom rlif for patints who hav faild othr tratmnts. Thr ar risks as thr ar for any surgry including graft donor sit morbidity. Ths potntial risks nd to b undrstood by th patint and thir family. Th risks, particularly donor sit morbidity nds to b wll undrstood by th patint and family. Thr ar risks of failur for any mdical or surgical tratmnt. 5. Is thr any vidnc missing from th attachd draft rviw of vidnc? No. Ys/No Citations of Missing Evidnc 1 No input availabl 2 No Ankl 6. For patints with focal articular cartilag injury of th ankl (g, ostochondritis disscans), ar thr clinical factors whr tratmnt with ostochondral autografts would b appropriat? No. Ys/No Explanation 1 Ys Ostochondral autografts ar appropriat for primary tratmnt of ostochondral lsions of th talus with a surfac ara > 150mm 2. Multipl studis hav found lsion siz to b an important prognostic factor whn marrow stimulation (g, microfractur) is mployd for th tratmnt of ostochondral lsions of th talus (OLT)[1-5,7]. Svral rtrospctiv cas sris hav dmonstratd good outcoms aftr marrow stimulation tchniqus for OLTs <150mm 2 and poor outcoms whn trating lsions >150mm 2. [4,5,7] Chuckpaiwong t al [3] prospctivly valuatd 105 patints aftr microfractur for OLT. Thy rportd no tratmnt Original Policy Dat: August 2001 Pag: 5

6 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions failurs in lsions smallr than 15mm, but only on succss in 32 patints with lsions largr than 15mm. Choi t al [2] valuatd 120 ankls tratd with microfractur for OLT. Thy rportd only 10 tratmnt failurs in 95 patints (10.5%) with lsions <150mm 2 compard to 20 failurs in th 25 patints (80%) with lsions >150mm 2. Eight of th 30 failurs wr subsquntly tratd with ostochondral autograft transplantation (AOT). Ths patints' AOFAS scors improvd from 53.6 (+/ ) pr-surgry to 85.2 (+/- 5.06) aftr th AOT procdur. This was vry similar to th avrag AOFAS scor of th patints who undrwnt a succssful primary microfractur procdur, 88.7 (+/- 5.61). On can conclud from ths studis that arthroscopic marrow stimulation tchniqus may not b th appropriat primary procdur for OLTs with a surfac ara >150mm 2. In at last on study, thos patints wr subsquntly succssfully tratd with ostochondral autograft transplantation [1], which has bn shown to hav gratr than 90% succss in a larg study of th tratmnt of ostochondral lsions, including 98 OLTs. [6] Both ostochondral autograft and allograft transplantations ar valid tratmnt options in rvision situations. Gross t al [8] rportd rsults of frsh ostochondral allograft transplantation in 9 patints with an avrag follow up of 12 yars. 67% of patints had grafts in situ without radiological vidnc of rsorption, fragmntation or dgnrativ chang. 33% of patints wnt on to ankl fusion du to graft failur. Kruz t al [9] rportd rsults of ostochondral autografting for ostochondral lsions of th talus that hav faild arthroscopic tratmnt in 35 patints with a man follow-up of 49 months. Th AOFAS hindfoot scor significantly improvd by 35.5 points. El-Rashidy t al [10] rportd improvmnt in VAS-pain from 8.2 to 3.3 and AOFAS scor from 52 to 79 points in 42 patints who undrwnt frsh ostochondral allograft transplantation. 89.5% achivd graft haling with significant improvmnt in pain and function. 74% of patints ratd th surgry as good-xcllnt. Mor than half of th sris ar rvisions. Kim t al [11] found no diffrnc in th outcoms including VAS-pain (6.9 to 3.3), AOFAS scor (67 to 83), and Tgnr scor (3 to 3.9) btwn primary ostochondral autograft transplantation and thos with prior arthroscopic marrow stimulation. 95%of patints rportd good to xcllnt rsults. Yoon t al [12] dmonstratd suprior rsults in 22 patints who undrwnt ostochondral autologous transplantation (Good-xcllnt 81.8%) ovr 22 patints who undrwnt rpat arthroscopy (Good-xcllnt 31.8%) in a lvl 3 study. Th rpat arthroscopy group suffrd from th significant dtrioration ovr a man follow-up of 50 months dspit having ncouraging arly rsults. Rvision surgry was rquird in 63.6% of rpat arthroscopy patints vrsus 0% in ostochondral autologous transplantation patints. Ahmad and Jons [13] conductd a prospctiv randomizd study in 40 patints that faild prior arthroscopy into ithr ostochondral autologous transplantation (20 patints) or ostochondral allograft transplantation (20 patints). Both groups dmonstratd similar and significant improvmnt in VAS pain (7.9-->2 vs 7.8--> 2.7), FAAM scor (54.4--> Original Policy Dat: August 2001 Pag: 6

7 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions 85.5 vs >80.7), and haling rat (90% vs 81.2%). Rfrncs 1. Cuttica DJ, Smith WB, Hyr CF, t al. Ostochondral lsions of th talus: prdictors of clinical outcom. Foot Ankl Int Nov;32(11): PMID: Choi WJ, Park KK, Kim BS, t al. Ostochondral lsion of th talus: is thr a critical dfct siz for poor outcom? Am J Sports Md Oct;37(10): PMID: Chuckpaiwong B, Brkson EM, Thodor GH. Microfractur for ostochondral lsions of th ankl: outcom analysis and outcom prdictors of 105 cass. Arthroscopy Jan;24(1): PMID: Cuttica DJ, Smith WB, Hyr CF, t al. Ostochondral lsions of th talus: prdictors of clinical outcom. Foot Ankl Int Nov;32(11): PMID: Gianni S, Cccarlli F, Girolami M, t al. Biological ostosynthsis in ostochondral lsions of th talus. Ital J Orthop Traumatol. 1989; 15(4): Hangody L, Vásárhlyi G, Hangody LR, t al. Autologous ostochondral grafting--tchniqu and long-trm rsults. Injury Apr;39 Suppl 1:S32-9. PMID: L KB, Bai LB, Chung JY, t al. Arthroscopic microfractur for ostochondral lsions of th talus. Kn Surg Sports Traumatol Arthrosc Fb;18(2): PMID: Gross AE, Agnidis Z, Hutchison CR. Ostochondral dfcts of th talus tratd with frsh ostochondral allograft transplantation. Foot Ankl Int May;22(5): PMID: Kruz PC, Stinwachs M, Ergglt C, t al. Mosaicplasty with autognous talar autograft for ostochondral lsions of th talus aftr faild primary arthroscopic managmnt: a prospctiv study with a 4-yar follow-up. Am J Sports Md Jan;34(1): PMID: El-Rashidy H, Villacis D, Omar I, t al. Frsh ostochondral allograft for th tratmnt of cartilag dfcts of th talus: a rtrospctiv rviw. J Bon Joint Surg Am Sp 7;93(17): PMID: Kim YS, Park EH, Kim YC, t al. Factors associatd with th clinical outcoms of th ostochondral autograft transfr systm in ostochondral lsions of th talus: scond-look arthroscopic valuation. Am J Sports Md Dc;40(12): PMID: Yoon HS, Park YJ, L M, t al. Ostochondral autologous transplantation is suprior to rpat arthroscopy for th tratmnt of ostochondral lsions of th talus aftr faild primary arthroscopic tratmnt. Am J Sports Md Aug;42(8): PMID: Ahmad J, Jons K. Comparison of ostochondral autografts and allografts for tratmnt of rcurrnt or larg talar ostochondral lsions. Foot Ankl Int Jan;37(1): PMID: YES OCD lsions of th talus, and traumatic chondral lsions. Faild non-oprativ tratmnt and microfractur. 7. For ach situation you dscribd in Qustion 6: Original Policy Dat: August 2001 Pag: 7

8 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions a. Plas fill in th first column of th tabl blow with ach indication you rportd. b. Plas rspond YES or NO whthr th us of ostochondral autografts for patints with focal articular cartilag injury of th ankl (g, ostochondritis disscans) would b xpctd to improv halth outcoms. c. Plas us th 1 to 5 scal outlind blow to indicat your lvl of confidnc that thr is adquat vidnc that supports your conclusions. Fill in th blanks blow with ach indication you rportd in Qustion 1 Low Confidnc Intrmdia t Confidnc No. Ys/No Lsion siz >150 mm 2 Ys X 1 Larg cystic lsions Ys X 1 Autograft transplantation in rvision ostochondral lsion of th talus Ys 1 Allograft transplantation in rvision ostochondral Ys lsion of th talus 2 Faild nonoprativ tratmnt Ys X 2 Faild microfractur Ys X 8. For ach situation you dscribd in Qustion 6: a. Plas fill in th first column of th tabl blow with ach indication you rportd. b. Plas rspond YES or NO whthr this clinical us is in accordanc with gnrally accptd mdical practic. c. Plas us th 1 to 5 scal outlind blow to indicat your lvl of confidnc that this clinical us is in accordanc with gnrally accptd mdical practic. X X High Confidnc Fill in th blanks blow with ach indication you rportd in Qustion 1 Low Confidnc Intrmdi at Confidnc No. Ys/No Lsion siz >150 mm 2 Ys X 1 Larg cystic lsions Ys X High Confidnc Original Policy Dat: August 2001 Pag: 8

9 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions 1 Autograft transplantation in rvision ostochondral lsion of th talus Ys 1 Allograft transplantation in rvision ostochondral Ys lsion of th talus 2 Faild nonoprativ tratmnt Ys X 2 Faild microfractur Ys X 9. Additional commnts and/or any citations supporting your clinical input on th clinical us of ostochondral autografts for patints with focal articular cartilag injury of th ankl. No. Additional Commnts 1 Ostochondral allografts hav bn shown to b usful for primary tratmnt of larg, cystic ostochondral lsions of th talus. In larg cystic lsions, as dfind by surfac ara >150mm 2 or volum >3000mm 3, arthroscopic marrow stimulation tchniqus ar unrliabl and obtaining an adquat volum of autograft carris th risk of significant morbidity. [1] In a Currnt Concpts Rviw articl publishd in 2013, Murowski and Knndy rcommndd ostoallograft transplant for patints with "larg-volum cystic lsions" and statd that th "procdur has th potntial to rduc pain and improv function for thos sking to avoid or dlay mor prmannt procdurs, such as ankl arthrodsis or total ankl arthroplasty." [2] A prospctiv study of th tratmnt of larg-volum cystic OLTs was conductd by Raikin.[3] H dmonstratd good or xcllnt rsults in 11/15 patints with vry larg lsions (man volum of 6059 mm 3 ). Although 67% of th grafts dmonstratd som rsorption, only two patints rquird convrsion to ankl arthrodsis. Avrag AOFAS scors incrasd from 38 proprativly to 83 at man follow up of 44 months. As dtaild abov, tratmnt of OLT with marrow stimulation tchniqus has poor rsults for lsions >150mm 2. Whn thos largr lsions also hav cystic chang, thy sm to b vn lss likly to rspond to marrow stimulation. Thrfor, primary tratmnt with ostochondral allograft transfr would b a rasonabl option for ths patints. Th tratmnt for an ostochondral lsion aftr a faild arthroscopic dbridmnt is challnging. Whil thr is a rol for a rpat arthroscopic dbridmnt, th rsults hav bn lss that optimal and oftn short-livd.[4] Autograft and Allograft transplantation hav bn succssfully usd in rvision situations with rasonabl succss.[4-9] Th us of ostochondral graft is clar spcially whn thr is significant cartilag and bon involvmnt prcluding othr cartilag-only rstoration mthods. Whil th us of autograft has a trnd for suprior rsults for graft haling, donor sit morbidity with chronic kn pain can b a caus of concrn ranging from 0-26% of patints.[7, 10] Howvr, ostochondral frsh allograft may b th only option in crtain cass with xtraordinary larg lsions or whn th lsions involv shouldr rgion of th talus.[5] Ovrall, both ostochondral autograft and allograft transplantation hav a dfinitiv rol in th tratmnt of uncommon but disabling rcurrnt ostochondral lsions of th talus. Rfrncs X X Original Policy Dat: August 2001 Pag: 9

10 Autografts ad Allografts in th Tratmnt of Focal Articular Cartilag Lsions 1. McCollum GA, Myrson MS, Jonck J. Managing th cystic ostochondral dfct: allograft or autograft. Foot Ankl Clin Mar;18(1): PMID: Murawski CD, Knndy JG. Oprativ tratmnt of ostochondral lsions of th talus. J Bon Joint Surg Am Jun 5;95(11): PMID: Raikin SM. Frsh ostochondral allografts for larg-volum cystic ostochondral dfcts of th talus. J Bon Joint Surg Am Dc;91(12): PMID: Yoon HS, Park YJ, L M, t al. Ostochondral autologous transplantation is suprior to rpat arthroscopy for th tratmnt of ostochondral lsions of th talus aftr faild primary arthroscopic tratmnt. Am J Sports Md Aug;42(8): PMID: El-Rashidy H, Villacis D, Omar I, t al. Frsh ostochondral allograft for th tratmnt of cartilag dfcts of th talus: a rtrospctiv rviw. J Bon Joint Surg Am Sp 7;93(17): PMID: Kim YS, Park EH, Kim YC, t al. Factors associatd with th clinical outcoms of th ostochondral autograft transfr systm in ostochondral lsions of th talus: scond-look arthroscopic valuation. Am J Sports Md Dc;40(12): PMID: Ahmad J, Jons K. Comparison of ostochondral autografts and allografts for tratmnt of rcurrnt or larg talar ostochondral lsions. Foot Ankl Int Jan;37(1): PMID: Gross AE, Agnidis Z, Hutchison CR. Ostochondral dfcts of th talus tratd with frsh ostochondral allograft transplantation. Foot Ankl Int May;22(5): PMID: Kruz PC, Stinwachs M, Ergglt C, t al. Mosaicplasty with autognous talar autograft for ostochondral lsions of th talus aftr faild primary arthroscopic managmnt: a prospctiv study with a 4-yar follow-up. Am J Sports Md Jan;34(1): PMID: Paul J, Sagstttr A, Krinr M, t al. Donor-sit morbidity aftr ostochondral autologous transplantation for lsions of th talus. J Bon Joint Surg Am Jul;91(7): PMID: An attmpt to trat a patint with an ostochondral autograft givs patints an opportunity to dcras pain and improv function and avoid a potntially gratr morbid procdur such as a fusion or total ankl arthroplasty, which may b inappropriat in a youngr patint. 10. Is thr any vidnc missing from th attachd draft rviw of vidnc? No. Ys/No Citations of Missing Evidnc 1 No 2 No Original Policy Dat: August 2001 Pag: 10

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