This is a post-market, multi-center, patient outcomes centered study to evaluate the on-label use of AccuFill during the Subchondroplasty procedure. Enrolled subjects will sign an informed consent form, satisfy the inclusion/exclusion criteria and have at least one Bone Marrow Lesion (BML) in the knee. Demographics, medical history and medications will recorded at the time of enrollment. Surgical details including the SCP procedure, concomitant surgical procedures and intraoperative safety events will be recorded. Subjects will complete patient reported outcomes measures pre-operatively including the Visual Analog Scale (VAS) for knee pain, International Knee Documentation Committee Subject Knee (IKDC) Form and the Veterans Rand 12 (VR-12) Item Health Survey. These measures will also be administered post-operatively at 6 weeks, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. Screening for adverse events and revision surgeries will occur throughout the study.
Target enrollment is 1000 subjects at up to 30 clinical sites. Subjects will complete the study at 5 years or will be withdrawn if the patient undergoes revision surgery of the Subchondroplasty site.
