JOCOAT Safety and Tolerability Clinical Trial GLAD-04

Pre-operative Inclusion Criteria:

• Understand and be able to follow the requirements of the protocol including personally signing and dating an REB approved Informed Consent Form prior to undergoing any protocol related procedures
• Subjects aged 15 to 25 years with an ACL-deficient knee undergoing primary ACLR
• Subjects with skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs)

• At least two of the following factors that are associated with a high risk of graft failure:

  1. participate in a competitive pivoting sport (defined as sports that include cutting and pivoting activities such as basketball, American football, soccer, lacrosse, volleyball, tennis/squash, handball, downhill skiing etc);
  2. have a pivot shift of grade 2 or greater;
  3. have generalized ligamentous laxity (Beighton score of >= 4) and/or genu recurvatum > 10 degrees
• Biological females have a negative pregnancy test within 4 days of initial surgery
• Is willing, able and likely to fully comply with clinical trial procedures and restrictions including follow-ups

Pre-operative Exclusion Criteria:

• Simultaneous bilateral ACLR
• Previous ACLR on either knee
• Less than one year from contralateral knee or contralateral/ipsilateral hip/ankle surgery
• Prior arthrotomy in the study knee
• Active infection anywhere or previous infection in the study knee
• History of peri-articular fracture in study knee
• > 3 degrees of asymmetric varus or valgus
• The patient has debilitating knee pain that would preclude the use of QT tissue as a graft
• The patient has a significant quad tendonitis that would preclude the use of QT tissue as a graft
• Known or suspected allergy to brown seaweed, seaweed-based materials such as fucoidan, food allergies and/or presence of any allergy related dietary restrictions unless deemed by the investigator as "Not Clinically Significant"
• Known or suspected allergy to fucose, galactose, sulfur, sulfate, sulfite, or any sugar-based polymer or polysaccharides containing these
• Known hypersensitivity to sodium lactate or sulfur-containing compounds
• Any other severe allergic conditions or previous reactions (e.g., anaphylactic reactions, angioedema)
• Severe metabolic acidosis or alkalosis
• Have insulin dependent diabetes, severe diabetes and/or poorly controlled diabetes mellitus
• Any general medical or surgical condition that would preclude a standard knee ACLR
• Inflammatory arthropathy
• Breast feeding
• Have a medical condition that, in the opinion of the investigator would interfere with the evaluation of the safety or efficacy of the investigational product
• Have received any investigational products that, in the opinion of the investigator, would interfere with the evaluation of the safety or efficacy of the investigational product
• Have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic, hematological or coagulation disorders
• Family history of blood or coagulation disorders
• History of heparin-induced thrombocytopenia (HIT) or known sensitivity to heparin-like products

Intra-operative Inclusion Criteria:

- Patient undergoes primary anatomic anterior cruciate ligament reconstruction surgery with quadriceps tendon (QT) graft

Intra-operative Exclusion Criteria:

• Pre-existing arthrofibrosis in the knee
• Partial ACL rupture (defined as one bundle ACL tear requiring reconstruction/ augmentation of the torn bundle with no surgery required for the intact bundle) where ACLR is not performed
• Multiple ligament injury (two or more ligaments requiring surgery)
• Symptomatic articular cartilage defect requiring treatment other than debridement
• Articular cartilage lesion that requires any other surgical treatment apart from debridement
• Under anesthetic, this patient has a symmetrical or grade 1 pivot shift AND has a Beighton score \<4 AND \<10 degrees hyperextension