Anterior Talofibular Ligament InjuryNCT04736238
Clinical Study on the Treatment of Chronic Instability of the Lateral Ankle Joint by Repairing the Anterior Talofibular Ligament Under Total Arthroscopy
A study testing Arthroscopy surgery and BrostrÖm surgery in people with Anterior Talofibular Ligament Injury and Ankle Sprains, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study mainly evaluated the clinical effect of total arthroscopic repair of the anterior talofibular ligament in the treatment of chronic instability of the lateral ankle. For patients with chronic instability of the lateral ankle, a randomized controlled trial was used to compare the curative effect, operation… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Talofibular Ligament Injury, Ankle Sprains
- What is being tested?
- Arthroscopy surgery and BrostrÖm surgery
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 15 Jan 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A history of acute lateral ankle sprain.
- The patient has chronic instability of the lateral ankle joint, including functional instability or mechanical instability; functional instability refers to the patient's subjective ankle joint looseness or instability; mechanical instability refers to the presence of the ankle joint History of repeated sprains, positive examination of the front drawer test or positive X-ray examination of the stress position (inversion stress, anterior axial stress).
- The ankle MRI suggested the anterior talofibular ligament injury.
- It is invalid after 3 months of formal conservative treatment.
Who cannot join
- Co-infection.
- There was a previous ankle fracture in the affected limb.
- The affected limb has previously undergone foot and ankle surgery.
- Ankle inverted arthritis or Charcot joint disease.
- Suffer from mental illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peking University People's Hospital
This study mainly evaluated the clinical effect of total arthroscopic repair of the anterior talofibular ligament in the treatment of chronic instability of the lateral ankle. For patients with chronic instability of the lateral ankle, a randomized controlled trial was used to compare the curative effect, operation time, surgical complications, postoperative recurrence rate, postoperative recovery time and patients' satisfaction of the total arthroscopic repair of the anterior talofibular ligament surgery and the modified BrostrÖm surgery.
- Being tested
- Arthroscopy surgery, BrostrÖm surgery
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopy surgeryProcedure or surgery
The patient receives intraspinal anesthesia or general anesthesia under supine position. Establish an anteromedial channel at the inner side of the tibial anterior tibial tendon at the level of the tibiotalar joint, and establish an anterolateral channel at the lateral angle of the talus. Exploring and clearing the ankle joint and dealing with possible combined injuries, such as talar cartilage injury, ankle impingement, and loose ankle joints. Then observe the lateral sulcus through the anterior medial channel, clean the synovium in the lateral sulcus, and explore the anterior talofibular ligament. A double-line anchor was inserted into the fibula side stop of the anterior talofibular ligament through the anterolateral channel. The anterior talofibular ligament was sutured using an outside-in technique in the anterior inferior safety zone of the distal end of the fibula. Fix the ankle joint with the suture after the dorsiflexion, neutral valgus position.
BrostrÖm surgeryProcedure or surgery
The patient receives intraspinal anesthesia or general anesthesia under supine position. The first ankle arthroscopy is performed to deal with possible combined injuries, such as talar cartilage injury, ankle impingement, and loose ankle joints. Then, open surgery was performed, and an arc incision was made at the anterior edge of the lateral malleolus to the tip of the fibula. After separating the subcutaneous tissue, the anterolateral joint capsule and talofibular ligament are exposed. A double-line anchor was placed at the fibular side stop of the anterior talofibular ligament. Tighten and suture the anterior talofibular ligament, anterolateral joint capsule, and extensor support belt with an anchor band. Fix the ankle joint with the suture after the dorsiflexion, neutral valgus position.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | The patients who receive arthroscopic surgery. Receives: Procedure: Arthroscopy surgery |
| Control group | Other | The patients who receive BrostrÖm surgery. Receives: Procedure: BrostrÖm surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
AOFAS ankle-hindfoot score
Measured: At 12 months after surgery
Secondary outcomes (3)
Visual Analog Scale for Pain
The pain VAS is available in the public domain at no cost [Arthritis Rheum 2003; 49: S96-104.]. Graphic formats for the VAS may be obtained online: http://www.amda.com/tools/library/whitepapers/hospiceinltc/appendix-a.pdf.
Measured: At 12 months after surgery
SF-36 Quality of Life Scale
Measured: At 12 months after surgery
Complications
Wound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.
Measured: At 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start1 Jun 2018
- Primary completion15 Jan 2021
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Talofibular Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hailin Xu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736238
- Sponsor's protocol ID
- ATFLMicro
- Status last verified
- Aug 2026
- First submitted
- 27 Jan 2021
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No