Mechanical Debridement Verus Radiofrequency-Based Debridement to Treat Articular Cartilage Lesions With Partial Meniscectomy in the Knee (ACT)

Inclusion Criteria:

Subjects MUST meet ALL of the following criteria to be included in the study:

1. Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
2. Is male or non pregnant female ≥ eighteen (18) years of age

3. Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters:

   1. Single, treatable chondral lesion, localized to the medial femoral condyle,
   2. ICRS Grade 3A,
   3. < 4cm2 in size
4. MRI within past 6 months confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy
5. Must present with pain in the index knee of moderate or severe (> 30 mm) as measured by the VAS
6. Must be able to understand English (written and oral)
7. Must be available to come to all study related visits and is physically and mentally willing and able to comply with all post-operative evaluations

8. Must be in general good health (as determined by the Investigator) based on screening assessments and medical history

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Exclusion Criteria:

Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:

1. Body Mass Index (BMI) > 35
2. Requires bilateral knee surgery

3. Any of the following conditions:

   1. active joint infections
   2. is immunocompromised, has Sickle Cell disease, has a primary bone disease (e.g., Paget's disease) or disorders that may adversely affect the healing process, or is terminally ill
   3. inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout)
   4. metastatic and/or neoplastic disease
   5. infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)
   6. coagulation disorder or patient is receiving anti-coagulants
   7. documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry
   8. diagnosed with a behavioral condition which could affect their ability to accurately comply with the study (e.g. developmental delay, attention deficit disorder, and autism)

4. Any of the following conditions in the index limb or joint:

   1. Grade III or greater osteoarthritis as determined by AP radiograph (Kellgren-Lawrence classification)
   2. drug therapy with systemic steroid therapy, steroid intra-articular therapy or intra-articular hyaluronic acid therapy within 6 months of enrollment into this study
   3. osteomyelitis, septicemia, or other infections that may spread to other areas of the body
   4. fractures, osteocysts or osteolysis
   5. recurrent patellar instability (e.g., subluxation or dislocation)
   6. severe Varus or Valgus knee deformities
   7. tear of the lateral meniscus
   8. avascular necrosis
   9. synovial disorders (e.g., pigmented villanodular synovitis)
   10. previous total or partial meniscectomy
   11. requires reconstruction or replacement of medial or lateral meniscus
   12. knee instability, malalignment, or patellar tracking dysfunction
   13. prior treatment for cartilage repair, including but not limited to ACI, Mosaicplasty and/or marrow stimulation procedures
   14. prior knee tendon and/or ligament repair or patellar surgery within the past 6 months

5. Any of the following conditions in the contralateral limb or joint:

   1. greater than minimal abnormality as shown by clinical exam and/or imaging
   2. scheduled or to be scheduled for surgery over the course of this study
   3. involvement causing abnormal ambulation and non-compliance with post-operative rehabilitation guideline
6. The subject has implanted metallic devices (insulin pumps, nerve stimulators, etc), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the knee
7. The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the index knee
8. Receiving prescription narcotic pain medication for conditions unrelated to the index knee condition
9. Cardiac pacemaker or other electronic implant(s)
10. Pregnant and/or intending to become pregnant during this study period
11. Participated in a clinical study within 6 months prior to surgery, or who is currently participating in another clinical study.
12. Is a prisoner, or is known or suspected to be transient
13. Is involved with Worker's Compensation unrelated to the index knee
14. Is involved with health-related litigation

Intra-operative Exclusion Criteria

Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:

1. Has more than 1 chondral lesion requiring treatment
2. Requires concomitant procedures (i.e., anterior cruciate ligament repair, high tibial osteotomy), excluding partial medial meniscectomy
3. Has a medial meniscal tear not requiring treatment
4. Has a medial meniscal tear requiring a procedure other than partial meniscectomy
5. Has a lateral meniscal tear requiring treatment