This study will assess the safety and efficacy of a new liquid anti-adhesion device, JOCOAT(TM) APN-3003 in patients undergoing knee anterior cruciate ligament reconstruction (ACLR) surgery. This is a single-center, prospective study. Safety and clinical outcomes will be compared with historical controls from enrolled study site patients from NCT03935750 (STABILITY 2) which has evaluated outcomes following ACL rupture in young athletes. A maximum of 24 patients aged 15-25 years undergoing primary anatomic ACLR with quadriceps tendon (QT) graft following a standardized surgical treatment algorithm will be enrolled. All patients will receive JOCOAT(TM) APN-3003 at the end of their surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
24
10 mL of JOCOAT(TM) APN-3003 is applied at the end of surgery
Safety of JOCOAT(TM) APN-3003 as measured by number and severity of adverse device effects and serious adverse device effects
The number of severe and serious adverse events in treated subjects from this study is compared with the number seen in historical controls
Time frame: 3 months after surgery
Exploratory efficacy of JOCOAT(TM) APN-3003 as measured by comparing range of motion (ROM) pre-operatively and post-operatively
Range of motion is measured pre-operative and post-operatively and compared
Time frame: 3 months after surgery
Patient recovery as measured by Patient Reported Outcome Measures (KOOS)
Patient reported outcome measure results (Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire) pre-operatively and post-operatively are compared with historical controls
Time frame: Up to 12 months after surgery
Patient recovery as measured by Patient Reported Outcome Measures (PASS)
Patient reported outcome measure results (Patient-Acceptable Symptom States (PASS) questionnaire) pre-operatively and post-operatively are compared with historical controls
Time frame: Up to 12 months after surgery
Patient recovery as measured by Patient Reported Outcome Measures (EQ-5D-5L)
Patient reported outcome measure results (EQ-5D-5L questionnaire) pre-operatively and post-operatively are compared with historical controls
Time frame: Up to 12 months after surgery
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