Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain

Inclusion Criteria:

- Patients who have given their written informed consent to participate in this clinical
study based on voluntary agreement after a thorough explanation of the patient's
participation is provided to them.

- Female patients who are not pregnant and do not plan to become pregnant during the
study. Females of child bearing potential must provide a negative pregnancy test
provided by the study physician and must be using reliable contraception and must
continue to use reliable contraception until study completion at 52 weeks.
Non-childbearing potential is defined as postmenopausal for at least 2 years or
surgical sterilization or hysterectomy at least 3 months before study start.

- Must be older than 18 years old..

- Must have chronic knee pain for at least 6 months.

- Must have radiologic evidence of OA of the knee, grade 2-4 based on the
Kellgreen-Lawrence scale.

- Persistent pain despite the use of conservative treatment (physical therapy, oral
analgesic, steroid injections).

- Must have a VAS score of at least 5 with ambulation.

- Subjects must be on a stable dose of pain medication regimen for at least 2 months.

- Greater than or equal to 50% improvement from blocks in target knee for duration of
the anesthetic.

Exclusion Criteria:

- Knee pain must not be acute.

- Previous total knee replacement.

- Evidence of connective tissue disease.

- Patients who have a BMI greater than 40.

- Evidence of serious neurological or psychiatric disorders.

- Current opioid use must not be greater than or equal to 90 mg morphine equivalent per
24 hour period.

- Must not have radicular pain in the affected limb.

- Patients with uncorrected coagulation disorders or who are on anticoagulation therapy
and cannot interrupt the therapy.

- Patients who have pacemakers or generators.

- Patient who are pregnant, breast-feeding or women of childbearing potential with
positive pregnancy tests.

- Sexually active female patients of childbearing potential who are not willing to use
adequate contraceptive measures to avoid pregnancy until week 52 of the study.
Sexually active male patients who are not willing to use adequate contraceptive
measures until week 52 of the study. Adequate methods of birth control include the
following: Hormonal contraception (female patients) or use of at least one acceptable
double-barrier method (for example: diaphragm plus spermicidal agent or condoms (male
or female) plus spermicidal agent.), vasectomy, intrauterine device, and/or exclusive
sexual partner for whom one of the above acceptable methods applies.

- Patients who have cancer or a past history of any cancer within 5 years prior to the
time of informed consent, with the exception of basal cell or squamous cell carcinoma
of the skin.

- Human immunodeficiency virus (HIV) infection or a clinically significant infection.

- A clinically significant disorder such as cerebrovascular disease, pulmonary
infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or
congestive heart failure.

- Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.

- Patients who have evidence of major psychiatric disease, mental disorder, drug
dependency, alcohol dependency, or substance abuse disorders.

- Any patient with a medical condition and/or disease that the Investigator believes
could affect the study results or the safe conduct of the study.

- Patients who are receiving compensation according to Workers' Compensation Act or are
involved in personal injury litigation.

- Patients who participated in another clinical study within 3 months prior to the time
of informed consent, or who are expected to participate in another study during the
period of this study.