Clinical Study on the Treatment of Chronic Instability of the Lateral Ankle Joint by Repairing the Anterior Talofibular Ligament Under Total Arthroscopy
Primary Purpose
Anterior Talofibular Ligament Injury, Ankle Sprains
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Arthroscopy surgery
BrostrÖm surgery
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Talofibular Ligament Injury
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Peking University People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Trial group
Control group
Arm Description
The patients who receive arthroscopic surgery.
The patients who receive BrostrÖm surgery.
Outcomes
Primary Outcome Measures
AOFAS ankle-hindfoot score
Secondary Outcome Measures
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.
SF-36 Quality of Life Scale
Complications
Wound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.
Full Information
NCT ID
NCT04736238
First Posted
January 27, 2021
Last Updated
February 2, 2021
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04736238
Brief Title
Clinical Study on the Treatment of Chronic Instability of the Lateral Ankle Joint by Repairing the Anterior Talofibular Ligament Under Total Arthroscopy
Official Title
Peking University People's Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
August 21, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Talofibular Ligament Injury, Ankle Sprains
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trial group
Arm Type
Experimental
Arm Description
The patients who receive arthroscopic surgery.
Arm Title
Control group
Arm Type
Other
Arm Description
The patients who receive BrostrÖm surgery.
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
BrostrÖm surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
AOFAS ankle-hindfoot score
Time Frame
At 12 months after surgery
Secondary Outcome Measure Information:
Title
Visual Analog Scale for Pain
Description
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
Title
SF-36 Quality of Life Scale
Time Frame
At 12 months after surgery
Title
Complications
Description
Wound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.
Time Frame
At 12 months after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study on the Treatment of Chronic Instability of the Lateral Ankle Joint by Repairing the Anterior Talofibular Ligament Under Total Arthroscopy
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