Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in the knee.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
181
Patients will undergo GelrinC implantation.
Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
Horizon Clinical Research
La Mesa, California, United States
Hoag Orthopedics
Orange, California, United States
University of Colorado
Denver, Colorado, United States
The change of physical functioning as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: 24 months post-surgery
The change of physical pain as assessed by patient reported outcome measure (Knee injury and Osteoarthritis Outcome Score (KOOS).
Time frame: 24 months post-surgery
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Shrock Clinical Research
Fort Lauderdale, Florida, United States
Andrews Institute
Gulf Breeze, Florida, United States
Jewett Orthopaedic Clinic
Orlando, Florida, United States
Optim Orthopedics
Savannah, Georgia, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
Peninsula Orthopaedic Associates
Salisbury, Maryland, United States
Tria Institute
Bloomington, Minnesota, United States
...and 3 more locations