Safety and Performance of the BIOSURE™ REGENESORB Interference Screw in Knee Ligament Repair and Reconstruction
This post-market clinical follow-up (PMCF) study will prospectively evaluate the short-term (6- and 12-month) safety and performance of the BIOSURE REGENESORB Interference Screw when used for any of the following: Knee repair: * ACL repair Posterior cruciate ligament (PCL) repair * Extra-capsular repairs * Medial collateral ligament (MCL) * Lateral collateral ligament (LCL) * Posterior oblique ligament (POL) * Patellar realignment and tendon repairs * Vastus medialis obliquus advancement * Iliotibial band tenodesis
Study Type
OBSERVATIONAL
Enrollment
60
OrthoIllinois
Rockford, Illinois, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Kelsey-Seybold Clinic/ Kelsey Research Foundation
Houston, Texas, United States
Graft fixation survival
Survival rate at 6 months
Time frame: 6 months
Graft fixation survival
Survival rate at 12 months
Time frame: 12 months
Graft survival at 6 and 12 months
where failure is defined as graft repair failure for any reason
Time frame: 6 months and 12 months
Quality of Life - International Knee Documentation Committee Score
Patient Reported Outcomes using International Knee Documentation Committee Score. Scores summed and normalized to 100, minimum score is 0 points and maximum score is 100 points. The lower the score, the greater the disability.
Time frame: Pre-Op, 6 months and 12 months
Quality of Life - Tegner Activity Scale
Patient Reported Outcomes using Tegner Activity Scale, subject indicates highest level of activity before injury and highest level of activity after injury. Levels on a scale from 0 to 10, with 10 being highest level.
Time frame: Pre-Op, 6 months and 12 months
Quality of Life - Lysholm Score
Patient Reported Outcomes using Lysholm Score, subject will answer eight questions on how knee pain has affected everyday life. Each question will be answered by placing a checkmark that best describes current condition.
Time frame: Pre-Op, 6 months and 12 months
Quality of Life - EQ-5D-5L
Patient Reported Outcomes using EuroQol Five Dimensions Questionnaire, subject will check box describing health on mobility, self-care, usual daily activities, pain/discomfort, and anxiety/depression. There are five checkbox options for each: no problems, slight, severe, unable to do activity. Subject will indicate from a scale of 1 to 100 (100 best), how good or bad is current health.
Time frame: Pre-Op, 6 months and 12 months
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