PROTOCOL

#9601

REVISED PROTOCOL PAGE REVISED CASE RECORD FORM

Page 24, Protocol #9601

2.

Exclusion Criteria a. Diagnosis of a concomitant injury of the contralateral or involved limb which the investigator believes may interfere with study participation (i.e. confound efficacy assessments or healing of the involved knee). b. Diagnosis of a concomitant lateral meniscal injury in involved knee which requires suture repair or excision of > 15% of the lateral meniscus. c. Diagnosis of a concomitant PCL injury in involved knee. d. Diagnosis of grade IV degenerative joint disease in the lateral, medial, or patellofemoral compartment(s). e. Previous treatment with collagen or injectable collagen. f. Documented allergy to collagen of animal origin. g. Infections, systemic or local. h. A history of anaphylactoid reaction. i. Pregnant females. j. A history of drug or substance abuse. k. Severe trauma other than as defined in this protocol. I. Clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, hematologic, autoimmune or any systemic disease which may make implementation/interpretation of the protocol or results difficult, m. Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immunostimulating or immunosuppressive agents, n. History of inflammatory arthritis, o. Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study. p. Pending litigation regarding the knee injury. q. Evidence of osteonecrosis in the involved knee, r. History of peripheral neuropathy, active on-going neoplastic disease, or immunosuppression.

COLLAGEN MENISCUS IMPLANT Patient ID

CASE RECORD FORM M01.C Protocol #9601 Page 1 of 3

INCLUSION/EXCLUSION CRITERIA

Patient Initials Evaluator

Exam

Date mm/ dd / yy

A. INCLUSION CRITERIA. All inclusion criteria must be answered "Yes" for study participation. a. Has received no prior treatment to the involved meniscus. b. Male or female, 18 to 60 years with good health. c. Diagnosis of injury to the knee resulting in an MRI or arthroscopically confirmed medial meniscus cartilage tear deemed to be primarily irreparable and requiring a partial meniscectomy. d. Diagnosis of degenerative joint disease of grade 0, I, II, or III in the lateral, medial, or patellofemoral compartment(s). e. If concomitant anterior cruciate ligament injury, the ACL must be stabilized within 12 weeks of implanting the CMI. QlYes Q2No

QlYes QlYes

Q2No Q2No

Yes

Q2No G3N/A Q2No Q3N/A Q2No Q2No Q2No Q2No U2No

f.

It has been at least three months since receiving any chondral regeneration procedures.

QlYes

g. Available for participation in the study during the course of the investigation (24 months follow-up). h. Agree to follow-up evaluations including "second-look" arthroscopy and biopsy. i. j. No scientific evidence of progression in healing, that is, no signs of spontaneous repair or regeneration of the meniscus. Willing to be randomized to either a control or CMI group, and willing to follow the respective rehabilitation program.

UlYes QlYes QlYes QlYes

k. Willing to sign the informed consent.

REGEN Biologies 4/3/97

COLLAGEN MENISCUS IMPLANT Patient ID

CASE RECORD FORM M01.C Protocol #9601 Page 2 of3

B. EXCLUSION CRITERIA. All exclusion criteria must be answered "No" for study participation. a. Diagnosis of concomitant injury of the contralateral or involved limb which the investigator believes may interfere with study participation (i.e. confound efficacy assessments or healing of the 1 involved knee). b. Diagnosis of a concomitant lateral meniscal injury in involved knee which requires suture repair or excision of > 15% of the lateral meniscus. c. Diagnosis of a concomitant PCL injury in involved knee. d. Diagnosis of grade IV degenerative joint disease in the lateral, medial, or patellofemoral compartment(s). e. Previous treatment with collagen or injectable collagen. f. Documented allergy to collagen of animal origin.

QlYes QlYes QlYes QlYes GlYes IJlYes

Q2No Q2No Q2No Q2No

g. Infections, systemic or local. h. A history of anaphylactoid reaction. i. j. 1. Pregnant female. A history of drug or substance abuse. Clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, hematologic, autoimmune or any systemic disease which may make implementation/interpretation of the protocol or results difficult. QlYes QlYes aiYes

Q2No Q2No Q2No Q2No U2No

k. Severe trauma other than as defined in this protocol.

m. Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immunostimulating or immunosuppressive agents. n. History of inflammatory arthritis. o. Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study. p. Pending litigation regarding the knee injury. q. Evidence of osteonecrosis in the involved knee. r. History of peripheral neuropathy, active on-going neoplastic disease, or immunosuppression.

UlYes QlYes

U2No

aiYes

Q2No

Q2No

REGEN Biologies 4/3/97

COLLAGEN MENISCUS IMPLANT Patient ID

CASE RECORD FORM M01.C Protocol #9601 Page 3 of 3

C. a. b.

Informed Consent/Treatment Indication Informed consent is signed by patient. Review study protocol and conditions with patient.

QlYes QlYes

Q2No Q2No

The Randomization Envelope may only be opened after this form is fully completed and signed.

(check here if the following -applies:) * This: patient is a candidate to receive the .Collagen Meniscus Implant. The final decision for* entrance into -the clinical study will be determined at the time of surgery. Physician's Signature >' ,

<*

Date

:*mm;;/, ddj yy
liJ (check 'here ifthe following^applies:)'"' 1 This patient isNOX. afcandidate<^oj[rec3eive the Collagen Meniscus Implant. '"V4 &f!t , ^! i> Physician's Signature ^ ^>^.J%<'^ * ^ ^ "* .'-Date''!? //^^
t * \* ^ S i -,y* j^ \ p.,
f

**'' I f ' < # * -f

REGEN Biologies 4/3/97

PROTOCOL #9602
REVISED PROTOCOL PAGE REVISED CASE RECORD FORM

o
1. Inclusion Criteria continued
,L. .. .. .. _-_L^-.^l'.-_ -

Page 24, Protocol #9602

i. j. k. 2.

No scientific evidence of progression in healing, that is, no signs of spontaneous repair or regeneration of the meniscus. Willing to be randomized to either a control or CMI group, and willing to follow the respective rehabilitation program. Willing to sign the informed consent.

Exclusion Criteria a. Diagnosis of a concomitant injury of the contralateral or involved limb which the investigator believes may interfere with study participation (i.e. confound efficacy assessments or healing of the involved knee). b. Diagnosis of a concomitant lateral meniscal injury in involved knee which requires suture repair or excision of > 15% of the lateral meniscus. c. Diagnosis of a concomitant PCL injury in involved knee. d. Diagnosis of grade IV degenerative joint disease in the lateral, medial, or patellofemoral compartment(s). e. Previous treatment with collagen or injectable collagen. f. Documented allergy to collagen of animal origin. g. Infections, systemic or local. h. A history of anaphylactoid reaction. i. Pregnant females. j. A history of drug or substance abuse. k. Severe trauma other than as defined in this protocol. I. Clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, hematologic, autoimmune or any systemic disease which may make implementation/interpretation of the protocol or results difficult, m. Systemic administration within 30 days prior to the study of any type of corticosteroid, antineoplastics, immunostimulating or immunosuppressive agents, n. History of inflammatory arthritis, o. Participation in another clinical trial using an investigational new drug or device within 30 days of entrance into this study. p. Pending litigation regarding the knee injury. q. Evidence of osteonecrosis in the involved knee, r. History of peripheral neuropathy, active on-going neoplastic disease, or immunosuppression.

COLLAGEN MENISCUS IMPLANT Patient ID

CASE RECORD FORM M01.C Protocol #9602 Page 1 of 3

INCLUSION/EXCLUSION CRITERIA

Patient Initials Evaluator

Exam Date mm/ dd / yy

A. INCLUSION CRITERIA. All inclusion criteria must be answered "Yes" for study participation. a. Has received one, two, or three prior treatments to the involved meniscus. b. Male or female, 18 to 60 years with good health. . c. Diagnosis of injury to the knee resulting in an MRI or arthroscopically confirmed medial meniscus cartilage tear deemed to be primarily irreparable and requiring a partial meniscectomy, debridement, or diagnostic arthroscopy. d. Diagnosis of degenerative joint disease of grade 0, I, II, or III in the lateral, medial, or patellofemoral compartment(s). e. If concomitant anterior cruciate ligament injury, the ACL must be stabilized within 12 weeks of implanting the CMI. f. It has been at least three months since receiving any chondral regeneration procedures. Q3N/A g. Available for participation in the study during the course of the investigation (24 months follow-up). h. Agree to follow-up evaluations including "second-look" arthroscopy and biopsy. i. j. No scientific evidence of progression in healing, that is, no signs of spontaneous repair or regeneration of the meniscus. Willing to be randomized to either a control or CMI group, and willing to follow the respective rehabilitation program. QlYes QlYes Q2No U2No QlYes Q2No QlYes QlYes Q2No G2No

QlYes QlYes QlYes

Q2No Q2No Q2No Q3N/A

k. Willing to sign the informed consent.

REGEN Biologies 4/3/97

COLLAGEN MENISCUS IMPLANT Patient ID

CASE RECORD FORM M01.C Protocol #9602 Page 2 of 3

B. EXCLUSION CRITERIA. All exclusion criteria must be answered "No" for study participation. Diagnosis of concomitant injury of the contralateral or involved limb which the investigator believes may interfere with study participation (i.e. confound efficacy assessments or healing of the involved knee). Diagnosis of a concomitant lateral meniscal injury in involved knee which requires suture repair or excision of > 15% of the lateral meniscus.

QlYes QlYes QlYes

G2No Q2No Q.2No

.-.;

c. Diagnosis of a concomitant PCL injury in involved knee. d. Diagnosis of grade IV degenerative joint disease in the lateral, medial,
or patellofemoral compartment(s).

CT2No Q2No

e. Previous treatment with collagen or injectable collagen. f. Documented allergy to collagen of animal origin. g. Infections, systemic or local. h. A history of anaphylactoid reaction.
Pregnant female. A history of drug or substance abuse. Severe trauma other than as defined in this protocol. Clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, hematologic, autoimmune or any systemic disease which may make implementation/interpretation of the protocol or results difficult.
m. Systemic administration within 30 days prior to the study of any type of

QlYes QlYes aiYes QlYes aiYes QlYes

U2No Q2No Q2No

Q2No

corticosteroid, antineoplastics, immunostimulating or immunosuppressive agents.

QlYes

Q2No Q2No

n. History of inflammatory arthritis. o. Participation in another clinical trial using an investigational new drug
or device within 30 days of entrance into this study.

aiYes
Q2No Q2No QlYes O!2No

p. Pending litigation regarding the knee injury. q. Evidence of osteonecrosis in the involved knee. r. History of peripheral neuropathy, active on-going neoplastic disease,
or immunosuppression.

REGEN Biologies 4/3/97

COLLAGEN MENISCUS IMPLANT Patient ID

c. a. b.

CASE RECORD FORM MOLC Protocol #9602 Page 3 of3 '

'

"

Informed Consent/Treatment Indication Review study protoco. and conditions with patient. Informed consent is signed by patient.

aiYes

QlYes

Q2No

The

H after this form is fully completed and signed. Randomization Enve.ope may only be opened after

Thisvpatient enl^nce'Tnto

REGEN Biologies 4/3/97