Clinical trial NCT06826898: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Talofibular Ligament Injury
Lead sponsor: Talent Cro Inc.
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is 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. With applying crosslinking hyaluronan hydrogel, the range of motion (ROM) of the ankle is expected to be better than sham group.


Eligibility 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.

Primary outcomes:
measure: Range of Motion (ROM)
timeFrame: day 14
Secondary outcomes:
measure: Range of Motion (ROM)
timeFrame: baseline, day 28, 49, 70
measure: Anterior Talar Translation (ATT)
timeFrame: baseline, day 14, 28, 49, 70
measure: Visual Analogue Scale (VAS) for pain
timeFrame: baseline, day 14, 28, 49, 70
measure: Cumberland Ankle Instability Tool (CAIT) questionnaire
timeFrame: baseline, day 14, 28, 49, 70
measure: American Orthopedic Foot and Ankle Society (AOFAS) questionnaire
timeFrame: baseline, day 14, 28, 49, 70
measure: Foot and Ankle Ability Measure (FAAM) questionnaire
timeFrame: baseline, day 14, 28, 49, 70
measure: Subject self-assessment satisfaction scores
timeFrame: day 14, 28, 49, 70
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
Study officials:
References: