Status:
TERMINATED
Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Chondral Lesion Plus Partial Medial Meniscectomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Radiof...
Detailed Description
This is a non-inferiority, prospective, double blinded, multi-center, randomized, controlled, adaptive study design with enrollment of 82 randomized subjects at up to 13 study sites. Study duration wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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:
- 1\. 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
- Exclusion Criteria
- 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
- knee instability, malalignment, or patellar tracking dysfunction
- prior treatment for cartilage repair, including but not limited to ACI, Mosaicplasty and/or marrow stimulation procedures
- prior knee tendon and/or ligament repair or patellar surgery within 6 months of enrollment into this study
- Any of the following conditions in the contralateral limb or joint:
- greater than minimal abnormality as shown by clinical exam and/or imaging
- scheduled or to be scheduled for surgery over the course of this study
- involvement causing abnormal ambulation and non-compliance with post-operative rehabilitation guideline
- 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
- The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the index knee
- Receiving prescription narcotic pain medication for conditions unrelated to the index knee condition
- Cardiac pacemaker or other electronic implant(s)
- Pregnant and/or intending to become pregnant during this study period
- Participated in a clinical study within 30 days of enrollment into this study, or who is currently participating in another clinical study.
- Is a prisoner, or is known or suspected to be transient
- Is involved with Worker's Compensation unrelated to the index knee
- 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:
- Has more than 1 chondral lesion requiring treatment
- Requires concomitant procedures (i.e., anterior cruciate ligament repair, high tibial osteotomy), excluding partial medial meniscectomy
- Has a medial meniscal tear not requiring treatment
- Has a medial meniscal tear requiring a procedure other than partial meniscectomy
- Has a lateral meniscal tear requiring treatment
Exclusion
Key Trial Info
Start Date :
March 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2017
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT01803880
Start Date
March 8 2013
End Date
July 21 2017
Last Update
March 28 2019
Active Locations (7)
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1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
2
Andrews Research and Education Foundation, Inc.
Gulf Breeze, Florida, United States, 32561
3
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, United States, 46143
4
Ohio State University
Columbus, Ohio, United States, 43221