Skip to content

Clinical Study on the Treatment of Chronic Instability of the Lateral Ankle Joint by Repairing the Anterior Talofibular Ligament Under Total Arthroscopy

Peking University People's Hospital

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04736238
Enrollment
54
Registered
2021-02-03
Start date
2018-06-01
Completion date
2025-01-15
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains, Anterior Talofibular Ligament Injury

Brief 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 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.

Interventions

PROCEDUREArthroscopy 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.

PROCEDUREBrostrÖm 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.

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. A history of acute lateral ankle sprain. 2. 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). 3. The ankle MRI suggested the anterior talofibular ligament injury. 4. It is invalid after 3 months of formal conservative treatment.

Exclusion criteria

1. Co-infection. 2. There was a previous ankle fracture in the affected limb. 3. The affected limb has previously undergone foot and ankle surgery. 4. Ankle inverted arthritis or Charcot joint disease. 5. Suffer from mental illness.

Design outcomes

Primary

MeasureTime frame
AOFAS ankle-hindfoot scoreAt 12 months after surgery

Secondary

MeasureTime frameDescription
Visual Analog Scale for PainAt 12 months after surgeryThe 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.
SF-36 Quality of Life ScaleAt 12 months after surgery
ComplicationsAt 12 months after surgeryWound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026