New gel could stop knee surgery scarring in young athletes
NCT ID NCT07081815
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests a liquid gel called JOCOAT APN-3003 that is applied during knee ACL reconstruction surgery to prevent internal scar tissue (adhesions). It involves 24 athletes aged 15 to 25. The gel is placed at the end of surgery, and researchers will check if it improves safety and recovery compared to past patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JOCOAT(TM) APN-3003 liquid adhesion barrier device
- What this could lead to
- If it works, this could reduce painful scar tissue after knee surgery, helping patients recover better range of motion and return to activity sooner.
- What could go wrong
- This is a very small early trial with only 24 people, comparing results to past patients rather than a control group. The device may not work better than standard care, and there is a risk of side effects like infection or allergic reaction.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.