May 16, 2008
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Enrollment goal of 15 patients
12 month enrollment period
Patients will be followed for five years
Inclusion Criteria:
1. Patients able and willing to give informed consent
2. Patients 18 years to 55 years of age
3. Patients presenting with symptomatic knee pain indicative of an articular cartilage injury
4. Patients medically able to undergo arthroscopic microfracture or biopsy and subsequent arthrotomy for NeoCart implantation
5. Patients with at least one treatable lesion located on either the medial or lateral femoral condyle that would be candidates for microfracture therapy
6. Patients having ICRS Grade III lesions
7. Patients with lesions having a maximum linear dimension of at least 1 cm and not more than 3 cm to a healthy cartilage border
8. Patients with lesions having a total area less than the area of NeoCart (7-8 cm2)
Exclusion Criteria:
9. Patients with any previous surgical treatment other than debridement or
microfracture of the study cartilage defect. Failed microfracture subjects must have continuing symptoms 1 year post index procedure, no substantial bone loss, and be otherwise eligible for a repeat microfracture procedure
10. Patients with a BMI > 35kg/m2
11. Patients with joint space narrowing greater than one third when compared to the normal knee, or less than 3 mm joint space measured on x-ray, osteophytes, sclerosis or degenerative conditions in the treatment knee as noted by x-ray
12. Patients with malalignment greater than 3 degrees outside the mechanical axis from other knee, or who require surgery to correct a malalignment
13. Patients with surgery on the contralateral knee within the 8 weeks prior to the scheduled arthroscopy
14. Patients with any form of inflammatory arthritis
15. Patients with ankylosing spondylitis
16. Patients with synovioma, hemangioma, PVNS, or other neoplasms in the knee
17. Patients on chemotherapy
18. Patients unable to undergo magnetic resonance imaging
19. Patients who are pregnant or intend to become pregnant during the year following initial enrollment
20. Patients with a known history of allergy to bovine products or to collagen or who exhibit more than a minimal reaction to an intradermal collagen injection challenge
21. Patients with any autoimmune disease
22. Patients with evidence of HIV, chronic hepatitis B or C viral infection
23. Patients with a known allergy to gentamicin
24. Patients with current drug or alcohol abuse
25. Patients deemed by the Investigator as likely to not comply with the Protocol
Delia Pais
212.606.1693
paisd@hss.edu