Torn Meniscus
Conditions
Keywords
Partial Meniscectomy, Partial Thickness Knee Tear, MR Imaging, Mechanical Debridement, Crepitus, Stability, Coblation, Bipolar Radiofrequency, Debridement, Recurrent Knee Pain, meniscectomy, meniscus, cartilage lesion, articular cartilage lesion, articular cartilage, knee
Brief summary
The aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based debridement.
Detailed description
Fibrillated articular cartilage are commonly detected during arthroscopy when treating knee pathologies such as a torn meniscus or a damaged anterior cruciate ligament (ACL). The severity of these lesions is graded using a scheme such as the International Cartilage Research Society (ICRS) classification system. Grade I lesions are often left untreated, while Grade IV lesions require dedicated surgical intervention. Grade II and III lesions are frequently treated when they are encountered arthroscopically. Currently, it is not known whether treatment of fibrillated articular cartilage is beneficial or whether one procedure is superior to another. Magnetic resonance imaging is the best technique currently available for non-invasive assessment of chondral lesions. The primary aim of the proposed study is to compare post-procedure MR imaging characteristics of fibrillated articular cartilage treated using one of the three standard of care measures: 1) Washing of the knee joint with saline solution to clear blood, fluid or loose tissue (also known as lavage); 2) Lavage in addition to mechanical shaver (a manual surgical tool used by the study doctor); and 3)Lavage in addition to the Paragon device (RF-based microdebridement), which may also be used with a mechanical (or manual) surgical tool. The secondary aim is to determine the association between imaging features and clinical outcomes.
Interventions
DEVICEMechanical debridement
Mechanical shaver will be used to remove large chondral flaps and loose fragments
DEVICEParagon T2
Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
PROCEDURELavage debridement
Remove loose chondral fragments
DEVICEMechanical Debridement
Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
DEVICERF- based Debridement
Use of debridement device to remove large fragments followed by use of RF-based debridement to smooth the base of the shoulder of the tear.
Sponsors
Smith & Nephew, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Screening * Age between 18 and 60 years * BMI \<35 * Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging in the index knee * No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee * No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization * No Varus (\>10 degrees) or Valgus (\>15 degrees)knee deformities as seen by AP X-ray in the index knee * Minimal or no abnormality of contralateral knee as shown by clinical exam and/or imaging * Candidate for unilateral arthroscopic treatment of the knee * Visual Analog Scale (VAS) pain score of 30 mm or greater in the index knee at the time of screening * Must be able to undergo MRI at required time points per appendix D * Physically and mentally willing and able to comply with study requirements * Must be willing and able to follow the standardized rehabilitation protocol (Appendix C) * Subject must sign IRB approved informed consent form Arthroscopy Inclusion Criteria: * Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle
Exclusion criteria
Screening * Knee instability, malalignment, or patellar tracking dysfunction in the index knee * Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee * Previous total meniscectomy in the index knee * Previous surgical treatment of the index knee by arthroscopy less than 2 years prior to treatment by this study * Previous total meniscectomy * Previous knee tendon and/or ligament repair or patellar surgery of index knee * Previous microfracture or bone marrow stimulation of the index knee * Previous unsuccessful osteotomy in the index knee * Presence of fractures, osteocysts or osteolysis in the index knee * Presence of osteoarthritis in the index knee * Pre-existent osteoarthritis of weight-bearing joints (e.g. hips or contralateral knee) that adversely affects gait * Participation in another clinical study * Terminally ill * Drug therapy for the index knee with systemic steroid therapy, steroid intra-articular therapy or intra-articular hyaluronic acid therapy within 2 months of enrollment into this study * Receiving narcotic pain medication by prescription for other conditions unrelated to knee injury * Contralateral knee involvement causing abnormal ambulation and non-compliance with rehabilitation * Pregnant or suspected pregnant * Coagulation disorder or patient is receiving anti-coagulants, which cannot be safely stopped for 14 days (7 days prior to surgery and 7 days post-surgery) Arthroscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion | 6 months after arthroscopy |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups | Up to 24 months |
Countries
United States
Outcome results
None listed