Evaluating a new hydrogel to prevent adhesions after ankle ligament surgery
A Prospective, Single-center, Randomized, Evaluator/subject-blinded, Controlled Clinical Study: to Evaluate the Effectiveness of the Use of a Novel Crosslinking Hyaluronan Hydrogel on the Prevention of the Adhesion Occurrence After Anterior Talofibular Ligament Repair Surgery
NA · Talent Cro Inc. · NCT06826898
This study is testing a new gel to see if it can help people who have had ankle ligament surgery avoid painful scar tissue and improve their ankle movement.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Talent Cro Inc. (other) |
| Locations | 1 site (Changhua) |
| Trial ID | NCT06826898 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of a novel crosslinking hyaluronan hydrogel in preventing adhesions following anterior talofibular ligament repair surgery. Participants will be randomly assigned to receive either the hydrogel or a sham treatment, with the expectation that those receiving the hydrogel will experience improved range of motion in their ankle. The study focuses on patients with confirmed anterior talofibular ligament injuries who have not responded to conservative treatments. The trial will monitor outcomes related to adhesion formation and functional recovery post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with confirmed anterior talofibular ligament injuries and a history of recurrent ankle sprains.
Not a fit: Patients with severe ankle osteoarthritis, prior ankle surgeries, or uncontrolled chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients undergoing ankle ligament repair by reducing adhesion formation.
How similar studies have performed: While this approach is innovative, similar studies using adhesion barriers have shown promise in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.1 Voluntarily participate and sign an informed consent form; 1.2 Age 18 to 60 years of male or female; 1.3 Patients experiencing lateral ankle pain discomfort, confirmed by MRI to have anterior talofibular ligament (ATFL) injury; 1.4 History of recurrent ankle inversion sprains three times or more, with no improvement after six months of conservative treatment, and scheduled for ATFL repair surgery; 1.5 Willing to comply with all follow-up requirements of the trial protocol. Exclusion Criteria: 2.1 Severe ankle osteoarthritis; 2.2 Patients with a history of ankle fracture or surgery; 2.3 Undergoing foot- or ankle-related treatments that may affect the trial results; 2.4 Presence of skin infection, skin defects, or need for skin grafting at the surgical site; 2.5 Uncontrolled chronic diseases, such as diabetes mellitus; 2.6 Presence of autoimmune diseases (such as Autoimmune Collagenopathy, rheumatoid arthritis), malignancies, coagulation disorders, heart diseases, psychiatric illnesses, or other conditions that may pose higher risks to patients in the trial; 2.7 Use of corticosteroids within the past 6 months, systemic corticosteroids within the past month, immunosuppressive drugs within the past 3 months, or daily use of non-steroidal anti-inflammatory drugs (NSAIDs) within the past week, or occasional use within 8 hours (patients using nasal/inhaled corticosteroids may be considered for inclusion) ; 2.8 Clinically significant coagulation abnormalities or undergoing anticoagulant therapy within 10 days before surgery or currently taking anticoagulant drugs; 2.9 Known allergy to sodium hyaluronate or any components of medical devices;allergy to Gram-positive bacterial protein or streptococcal protein；or other severe allergic history deemed unsuitable for participation by the investigators; 2.10 Pregnant, lactating women, or women planning to become pregnant during the trial period; 2.11 Other conditions deemed unsuitable for participation by the investigators.
Where this trial is running
Changhua
- Show Chwan Memorial Hospital — Changhua, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Yan-Yu Chen Doctor
- Email: swallowfish@gmail.com
- Phone: +88647684326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anterior Talofibular Ligament Injury