JOCOAT Safety and Tolerability Clinical Trial GLAD-04

ARC Medical Inc.

Status

Not yet enrolling

Conditions

Surgical Adhesions

Treatments

Device: JOCOAT(TM) APN-3003

Study type

Interventional

Funder types

Industry

Identifiers

NCT07081815

ARCMD-GLAD-04

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

15 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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