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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
165
Mechanical shaver will be used to remove large chondral flaps and loose fragments
Use Paragon device to debride after removal of larger chondral lesion flaps with mechanical shaver.
Remove loose chondral fragments
HOPE Research Institute
Phoenix, Arizona, United States
Kerlan Jobe Orthopaedic Foundation
Los Angeles, California, United States
JDP Medical Research
Aurora, Colorado, United States
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion
Time frame: 6 months after arthroscopy
To determine whether recovery from recurrent pain, effusion, localized mechanical symptoms, and quality of life are equivalent for treatment groups
Time frame: Up to 24 months
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Use of a mechanical device such as a shaver, punch, or biter to remove large chondral flaps and loose fragments
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.
Colorado Orthopedic Consultants, P.C.
Englewood, Colorado, United States
Shrock Orthopedic Research, LLC
Fort Lauderdale, Florida, United States
University of Mass. Memorial Medical Center
Worcester, Massachusetts, United States
University of Rochester Medical Center Department of Musculoskeletal Research
Rochester, New York, United States
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States
Commonwealth Orthopaedics
Arlington, Virginia, United States
Anderson Clinic
Arlington, Virginia, United States