Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions

Exclusion Criteria

• •Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
• •1. Body Mass Index (BMI) \> 40 or index joint pain is due to BMI (as determined by Investigator)
• •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 12 months of enrollment into this study
• •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. systemic steroid therapy or steroid intra-articular therapy within 4 weeks of enrollment into this study
• •3. intra-articular viscosupplementation within 3 months of enrollment into this study
• •4. osteomyelitis, septicemia, or other infections that may spread to other areas of the body
• •5. fractures, osteocysts or osteolysis
• •6. recurrent patellar instability (e.g., subluxation or dislocation)
• •7. severe Varus or Valgus knee deformities (as determined by Investigator)
• •8. symptomatic tear of the lateral meniscus
• •9. avascular necrosis
• •10. synovial disorders (e.g., pigmented villanodular synovitis)
• •11. previous total or partial meniscectomy
• •12. requires reconstruction or replacement of medial or lateral meniscus
• •13. knee instability, malalignment, or patellar tracking dysfunction
• •14. prior treatment for cartilage repair, including but not limited to ACI, Mosaicplasty and/or marrow stimulation procedures
• •15. prior knee tendon and/or ligament repair or patellar surgery within 6 months of enrollment into this study
• •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 30 days of enrollment into this study, 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
• •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