Clinical Trials

Inclusion Criteria:

Pre-operative

1. Voluntary signature of Informed Consent.
2. Male or female subject between the ages of 18-60 years.
3. ACL and PCL in the affected knee are stable, do not require surgical intervention, and has not been surgically reconstructed within 6 months. 
4. The contralateral knee is asymptomatic or minimally symptomatic, stable, fully functional, and requires no treatment.
5. Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical visits through defined timeframe.
6. Diagnosed by MRI with patellofemoral articular cartilage defect and scheduled to undergo surgical repair of a trochlea OR patella cartilage defect using Cartiform.

Intra-Operative

1. Pretreatment arthroscopic confirmation indicates the lesion is equal to an ICRS Grade 3a, 3b, 3c, 3d contained or semi-contained (>75%) lesion that is equivalent to an Outerbridge Grade III or IV (greater than 50% loss of articular cartilage).
2. The opposing cartilage surface is graded as a 0, 1 or 2 according to ICRS classification.
3. Has peripheral cartilage debridement to healthy cartilage that results in one lesion with an area greater than 1 cm2 but less than 7 cm2   
4. According to surgeon judgment, the knee has functional menisci after surgery completion (partial meniscectomy or meniscal repair resulting in stable, functional menisci is allowed).

Exclusion Criteria:

1. Kellgren Lawrence of 4
2. Body Mass Index >38 (BMI=kg/m2).
3. Failed microfracture treatment performed less than 12-months before baseline.
4. Failed cartilage resurfacing procedure performed (i.e. DeNovo, ACI, etc.). 
5. Prior realignment surgery in the affected knee within the past 6 months (Tibial Tubercle Osteotomy (TTO) is allowed at the time of surgery as needed).
6. Has received, within the past three months, any intra-articular injections in the index knee.
7. Is receiving one of the following types of prescription medications:
   1. Pain medication other than NSAIDs or acetaminophen, chronic use of anticoagulants, corticosteroids, growth hormone, or testosterone.
8. Diagnosis in the affected knee of:
   1. Global osteoarthritis, avascular necrosis, meniscal deficiency requiring a meniscal replacement.
9. Prior total meniscectomy of either knee.
10. History of:
    1. Rheumatoid arthritis, septic or reactive arthritis, gout or pseudogout.
    2. Secondary arthropathies (i.e., sickle cell disease, hemochromatosis, or autoimmune disease).
11. Active joint infection.
12. Uncontrolled diabetes.
13. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease.
14. Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 5 year endpoint.
15. Is at substantial risk for the need of organ transplantation, such as renal insufficiency.
16. Pregnant or breast-feeding at the time of enrollment.
17. Has a neuromuscular, neurosensory, or musculoskeletal deficiency that limits the ability to perform objective functional assessment of either knee.
18. Is receiving workman’s compensation or currently involved in litigation relating to the index knee.
19. Has history of alcoholism, medication or intravenous drug abuse, psychosis, is a prisoner, has a personality disorder(s), poor motivation, emotional or intellectual issues that would likely make the subject unreliable for the study, or any combination of variables in the investigator’s judgment that should exclude a potential subject.

Intra-Operative

1. Has bipolar articular cartilage involvement or kissing lesions within the patellofemoral compartment (described as apposing lesions in the same compartment with greater than ICRS grade 2 chondrosis).