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

Not Applicable

• Conditions: Ankle Sprains; Anterior Talofibular Ligament Injury
• Interventions: Procedure: Arthroscopy surgery; Procedure: BrostrÖm surgery

• Registration Number: NCT04736238
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2021-01-27
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Study First Posted: 2021-02-03
• Last Update Posted: 2021-02-03
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trial group	Arthroscopy surgery	The patients who receive arthroscopic surgery.
Control group	BrostrÖm surgery	The patients who receive BrostrÖm surgery.

Primary Outcome Measures

Name	Time	Method
AOFAS ankle-hindfoot score	At 12 months after surgery

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale for Pain	At 12 months after surgery	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.
SF-36 Quality of Life Scale	At 12 months after surgery
Complications	At 12 months after surgery	Wound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China