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CompletedNCT04736238Updated Aug 18, 2026

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

An interventional study of Arthroscopy surgery and BrostrÖm surgery in Anterior Talofibular Ligament Injury and Ankle Sprains, sponsored by Peking University People's Hospital. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jun 2018, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Sex
All
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Study 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.

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Conditions studied

  • Anterior Talofibular Ligament Injury
  • Ankle Sprains

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In context

Ankle Injuries

351 studies on the registry are indexed under Ankle Injuries; 71 are open to participants now.

This study's enrollment of 54 is close to the median of 56 across 273 interventional studies indexed under Ankle Injuries.

Browse Ankle Injuries studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Trial group

    The patients who receive arthroscopic surgery.

    Procedure: Arthroscopy surgery

  • Other
    Control group

    The patients who receive BrostrÖm surgery.

    Procedure: 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.

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What researchers measure

Primary outcomes

  1. AOFAS ankle-hindfoot score

    Time frame: At 12 months after surgery

Secondary outcomes

  1. 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.

    Time frame: At 12 months after surgery

  2. SF-36 Quality of Life Scale

    Time frame: At 12 months after surgery

  3. Complications

    Wound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.

    Time frame: At 12 months after surgery

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Study locations

1 site
  • Peking University People's Hospital
    Beijing, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04736238
Lead sponsor
Peking University People's Hospital
Responsible party
Hailin Xu (Associate Professor, Peking University People's Hospital) — Principal investigator
First posted
Feb 3, 2021
Start date
Jun 1, 2018
Primary completion
Jan 15, 2021
Completion
Jan 15, 2025
Last update
Aug 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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