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

Stopped early · Not applicable

Conditions studied: Chondral Lesion Plus Partial Medial Meniscectomy

In brief

The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.

Key facts

Study ID

NCT01803880

Run by

Smith & Nephew, Inc.

People needed

148

Starts

2013-03-08

Expected to finish

2017-07-21

Last updated by the study team

2019-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects MUST meet ALL of the following criteria to be included in the study:
• Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
• Is male or non pregnant female ≥ eighteen (18) years of age
• MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator)
• Must present with pain in the index knee of moderate or severe (> 30 mm) as measured by the VAS
• Must be able to understand English (written and oral)
• 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
• Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
• Intra-operative Inclusion Criteria
• Subjects MUST meet ALL of the following criteria to be included in the study:
• Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters:
• Single, treatable chondral lesion, localized to the medial femoral condyle,
• ICRS Grade 2 with widely displaceable fibrillation or flaps or Grade 3A,
• < 4cm2 in size

You may not qualify if…

• Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
• Body Mass Index (BMI) > 40 or index joint pain is due to BMI (as determined by Investigator)
• Requires bilateral knee surgery
• Any of the following conditions:
• active joint infections
• 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
• inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout)
• metastatic and/or neoplastic disease
• infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)
• coagulation disorder or patient is receiving anti-coagulants
• documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within 12 months of enrollment into this study
• 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)
• Any of the following conditions in the index limb or joint:
• Grade III or greater osteoarthritis as determined by AP radiograph (Kellgren-Lawrence classification)
• systemic steroid therapy or steroid intra-articular therapy within 4 weeks of enrollment into this study
• intra-articular viscosupplementation within 3 months of enrollment into this study
• osteomyelitis, septicemia, or other infections that may spread to other areas of the body
• fractures, osteocysts or osteolysis
• recurrent patellar instability (e.g., subluxation or dislocation)
• severe Varus or Valgus knee deformities (as determined by Investigator)
• symptomatic tear of the lateral meniscus
• avascular necrosis
• synovial disorders (e.g., pigmented villanodular synovitis)
• previous total or partial meniscectomy
• requires reconstruction or replacement of medial or lateral meniscus

Where it is running

• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• Andrews Research and Education Foundation, Inc. — Gulf Breeze, Florida, United States
• Orthopaedic Research Foundation, Inc. — Greenwood, Indiana, United States
• Ohio State University — Columbus, Ohio, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Methodist Center For Orthopedic Surgery — Houston, Texas, United States
• Basin Orthopedic Surgical Specialists — Odessa, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.