Attachment J3 - Part 2 - IDE Study CRFs

8/13/2019 Attachment J3 - Part 2 - IDE Study CRFs

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PROTOCOL 9601R VIS PROTOCOL P GE

R VIS C SE RECORD FORM


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Page 24, Protocol #9601

2. Exclusion Criteriaa. Diagnosisof aconcomitant injuryof thecontralateralorinvolved

limb which the investigator believes may interfere with studyparticipation i.e.confound efficacy assessmentsorhealingof theinvolved knee).

b. Diagnosis of a concomitant lateral meniscal injury in involved kneewhich requires suture repairorexcisionof > 15% of the lateralmeniscus.c. Diagnosisof aconcomitantPCLinjuryininvolved knee.d. DiagnosisofgradeIVdegenerative joint diseasein thelateral,medial,orpatellofemoral compartment(s).e. Previous treatment with collagen or injectable collagen.f. Documented allergy to collagen ofanimalorigin.g. Infections, systemicorlocal.h. Ahistoryofanaphylactoid reaction.i. Pregnant females.j. Ahistoryofdrugorsubstance abuse.k. Severe trauma other thanasdefinedinthis protocol.I. Clinically significant(asdefinedby theinvestigator)renal,hepatic,

cardiac, endocrine, hematologic, autoimmune or any systemicdisease whichmaymake implementation/interpretationof theprotocol or results difficult,m. Systemic administration within 30 days prior to the study of any typeofcorticosteroid, antineoplastics, immunostimulating orimmunosuppressive agents,

n. Historyofinflammatory arthritis,o. Participation in another clinical trial using aninvestigationalnew

drugordevice within30daysofentrance into this study.p. Pending litigation regarding the knee injury.q. Evidenceofosteonecrosisin theinvolved knee,r. History of peripheral neuropathy, activeon-goingneoplasticdisease, or immunosuppression.


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C O L L A G E N ME N I SCUS I MPL A N TPatient ID CA SE RECORD FORM M01.CProtocol #9601Page 1 of 3INCLUSION/EXCLUSIONCRITERIA

Patient Ini t ialsEva lua to r

Exam Datem m / dd / yy

e. If concomitant anterior cruciate ligament injury, the ACL m u s t bestabilized within 12weeks of implan t ingth e CMI.

f. It has been at least three months since receiving an ychondra lregeneration procedures.g. Av ailable for participation in the study dur ing the course of theinvest igat ion (2 4 months fo l low-up) .h. Agree to fol low -up evalu at ions i nc l ud ing second-look arthroscopyan d biopsy .i. N o scient if ic evidence of progression in heal ing , that is, nos igns of spontaneous repair orregeneration of the meniscus .j . W i l l i n gto be randomizedto eithera control or CMI group ,a ndw i l l i ngto fol low the respect ive rehab il i tat ion program.k . W i l l i n g to s ign the informed consent .

QlYesQlYes

A . INCLUSION CRITERIA. All inclus ion criteria m u s t be answered Yes for study participation.a. Hasreceived no prior treatmentto the involved meniscus. QlYes Q2Nob. Male or female, 18 to 60 years with good health.c. Diagnosis of injury to the knee result ing in an MR I or arthroscopicallyconfirmed m edi al m eni scu s cartilage tear deemed to be pr imar i ly

i r reparable and re qu ir ing a part ial meniscectomy.d. Diagnosis of degenerative joint disease of grade 0, I, II, or III in thelateral, m edial , or patel lofemoral compartment(s ) .Q2NoQ2No

Y e s Q2NoG3N/A

QlYes Q2NoQ3N/A

UlYes Q2No

QlYes Q2NoQlYes Q2No

QlYes Q2NoU2No

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COLLAGEN MENISCUSIMPLANTPatientID CASE RECORD FOR M M01.CProtocol#9601Page2 of3B. EXCLUSIONCRITERIA. All exclus ion criteria m u s t be answered "No" forstudy participation.

a. Diagnosis of concom itant in jury o f the contralateral or inv olved lim bwhich the investigator believes may interfere with s tudy participation(i.e. confound efficacy assessments or heal ing of the1 involved knee) .

b. Diagnosis of a concom itant lateral m eniscal in jury in involved kneewhich requires suture repair or excision of > 15% of the lateral meniscus.c . Diagnosis of a conco m itant PCL in jury in involved knee .d. Diagnosis of grade IV degenerative joint disease in the lateral, medial,or pate l lofemoral comp artment(s ) .e. Previous treatment w ith collagen or injectable collagen.f. Docum ented allergy to collagen of an ima l orig in .g. Infections, system ic or local.h . A history of anaphylactoid reaction.i. Pregnant female .j . A history ofdrug or substance abuse.k. Severe traum a other than as defined in th is protocol.1 . Cl in ical ly s ignif icant(a s defined by the investigator) renal, hepatic,cardiac, endocr ine , hematologic , au toimmuneor any systemic diseasewh i c h m ay make imp lemen ta t ion / in te rp re ta t ion of the protocol orresults difficult .m . Sys temic adm inis t ra t ion with in 30 days prior to the study of any type of

cor ticosteroid, ant ineoplas tics , im m un os t im ulat in g or im m uno sup press iv eagents.n . History of inf lammatory ar thr i t i s .o. Participation inanother c l in ical tr ia l us ingan inves t igat ionalnew drugor device wi t h i n 30 days of entrance into this s tudy.p. Pending litigation regarding the knee i n j u r y .q. Evid ence of osteonecrosis in the inv olved knee.r. History of peripheral neuropathy, active on-going neoplastic disease,

or immunosuppress ion .

QlYes Q2NoQlYesQlYes

QlYesGlYesIJlYes

QlYesQlYesaiYes

UlYesQlYes

Q2NoQ2No

Q2No

Q2NoQ2NoQ2NoQ2NoU2No

U2No

aiYes Q2No

Q2No

R E G E N Biologies 4/3/97


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C O L L A G E N MENISCUS IMPLANTPatient ID

C. Informed Consent/Treatment Indicationa. Informed consent is s igned by pat ient .b. Rev iew study protocoland condi t ions wi th pat ient .

C A S E RECORD FORM M01.CProtocol#9601Page3 of 3

Q l Y e s Q 2 N oQ l Y e s Q 2 N o

The Randomization Envelope may on ly be opened after this fo rm is ful ly completed and signed.

(check here if the fo l lowing -applies:) * This: patient is a candidate to receive the.Collagen Meniscus Implant. The f ina l decision for*entrance into -the clinical study will be determined at the time of surgery.

- 15 of the lateralmeniscus.c. Diagnosisof aconcomitantPC Linjury in involved knee.d. Diagnosis ofgrade IVdegenerative joint disease in the lateral,medial, orpatellofemoral compartment s).e. Previous treatment with collagenor injectable collagen.f. Documented allergytocollagen ofanimalorigin.g. Infections, systemicorlocal.h. Ahistoryofanaphylactoid reaction.i. Pregnant females.j. Ahistoryofdrugorsubstance abuse.k. Severe trauma other than asdefinedinthis protocol.I. Clinicallysignificant(as defined by the investigator)renal,hepatic,cardiac, endocrine, hematologic, autoimmuneor anysystemicdisease whichmaymake implementation/interpretation of theprotocolorresults difficult,m. Systemic administration within30days priorto thestudyof anytypeof corticosteroid, antineoplastics, immunostimulating orimmunosuppressive agents,n. Historyofinflammatory arthritis,o. Participation inanother clinical trial usinganinvestigational newdrug ordevice within30daysofentrance into this study.p. Pending litigation regarding the knee injury.q. Evidence ofosteonecrosisin the involved knee,r. Historyofperipheral neuropathy, active on-going neoplastic

disease, orimmunosuppression.


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C O LLA G EN MEN IS C U S IMP LA N TPatient ID C A S E RECORD FORM M01.CProtocol #9602Page 1 of 3

INCLUSION/EXCLUSIONCRITERIA

Pat ien t In i t ia l sEva lua to r

Exam Datem m / dd / yy

A. INCLUSION CRITERIA. All inc lus ion criteria m u s t be answered Yes for study participation.a. Has received one, two, or three prior treatments to theinvo lvedmeniscus .b. Male or fem ale, 18 to 60 years w ith good hea lth. .c. Diagnosis of injury to the knee resu l t ingin an M RI or arthroscopically

confirmed medial meniscus cartilage tear deemed to be pr imari lyirreparable and requ i r i ng a part ial meniscectomy, debridement,o rdiagnost ic ar throscopy.d. Diag nos is of degen erative jo in t disease of grade 0, I, II, or III in thelateral, medial, or patellofemoral compartment(s).e. If concomitant anter ior cruciate l igament in jury, the ACL m u s t be

stabil ized w i t h i n 12weeks of imp lan t i ng th e CMI.f. It has been at least three months since receiving any chon dralregeneration procedures.g. A v a i l a b l efor p ar t ic ipa t ionin the study d u r i n g th e course of theinves t igat ion (24 months fo l low-up) .h . Agree to follow-up evaluat ions i nc l ud ing "second-look" arthroscopy

and biopsy .i. N o scient ific evidence of progression in heal ing, that is, nos igns of spontaneous repairor regeneration of them e n i s c u s .j . W il l in g to be random ized to ei ther a control or CM I group, andw i l li ngto follow th e respective rehab il i tat ion program.k . W i l l i n g to s ign th e informed consent.

QlYes Q2NoQlYes G2No

QlYes Q2No

QlYes Q2No

QlYes Q2NoQ3N/A

Q3N/AQlYes Q2No

QlYes Q2NoQlYes U2No

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C O L L A G E N MENISCUS I M P L A N TPatient ID C A S E RECORDFORM M01.CProtocol#9602Page2 of 3

B. EXCLUSION CRITERIA. All exclusion criteria m u s t beanswered No for study participation.

c.d.e.f.g.h .

m.

n .o.p.q.r.

Diagnosis of concomitant in jury of the contralateral or involved l i m bwh i c h th e investigator believes m ay interfere with s tudy participation(i.e. confound efficacy assessments or heal ing of thei nvo lved knee) .Diagnosis of a concomitant lateral meniscal in jury in involved kneew h i c h requires suture repair or excis ion of > 15% of the lateral m eniscus.Diagnosis of a concomitant PCL in jury in involved knee .Diagnosis of grade IV degenerative jo i n tdisease in the lateral, medial,o r pate l lofemoral compartment(s ) .Previous treatment with collagen or injectable collagen.Docum ented allergy to collagen of an im al origi n.Infect ions , systemic or local.A his tory of anaphylac toid reac t ion .Pregnant female .A history of drug or substance abuse.Severe trauma other than as defined in this protocol.Clinical ly sig nifi can t (as defined by the investigator) renal, hepatic,cardiac, endocrine, hematologic, autoimmune or any system ic diseasewh i c h m ay make implementat ion/ in terpre ta t ion of the protocol orresults diff icult .Systemic adm inis t ra t ion w ith in 30 days pr ior to the study of any type ofcor ticos teroid, ant ineoplas t ics, im m uno s t im ulat in g or im m unosu ppress iveagents .History of inf lammatory ar thr i t i s .Participation in another cl inical trial u s i n g an inves t igat ionaln ew drugor device with in 30 days of entrance into this s tudy.Pending litigation regarding the knee i n j u r y .Ev idence of osteonecrosis in the involved knee .History of per ipheral neuropathy, ac t ive on-going neoplas t ic disease,or immunosuppres s ion .

Q l Y e s G 2 N oQ l Y e sQ l Y e s

Q l Y e sQ l Y e saiYesQ l Y e saiYesQ l Y e s

Q l Y e s

aiYes

Q 2 N oQ.2No

.

CT2NoQ2NoU2NoQ2NoQ2No

Q 2 N o

Q2NoQ2No

Q2NoQ2No

QlYes O 2No

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COLLAGEN MENISCUS IMPLANTPatientID ' 'c. Informed Consent/Treatment Indicationa. Review study protoco.andconditions with patient.

b. Informed consent is signed by patient.

CASE RECORD FORM M O L CProtocol #9602Page3 of3

i esQlYes Q2No

H after this form is fully completed and signed.The Randomization Enve.ope mayonly beopened after

Thisvpatientenl^nce'Tnto

R E G E N Biologies4/3/97

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Attachment J3 - Part 2 - IDE Study CRFs