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

Ankle Sprains Clinical Trial

Official title:

Peking University People's Hospital

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04736238
• Other study ID #: ATFLMicro
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: August 21, 2021

Study information

• Verified date: February 2021
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 44
• Est. completion date: August 21, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Anterior Talofibular Ligament Injury

Intervention

Procedure:
• Arthroscopy 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 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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AOFAS ankle-hindfoot score		At 12 months after surgery
Secondary	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.	At 12 months after surgery
Secondary	SF-36 Quality of Life Scale		At 12 months after surgery
Secondary	Complications	Wound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.	At 12 months after surgery