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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|ClinicalTrials.gov Identifier: NCT04736238|
Recruitment Status : Enrolling by invitation
First Posted : February 3, 2021
Last Update Posted : February 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anterior Talofibular Ligament Injury Ankle Sprains||Procedure: Arthroscopy surgery Procedure: BrostrÖm surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Peking University People's Hospital|
|Actual Study Start Date :||March 6, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||August 21, 2021|
Experimental: Trial group
The patients who receive arthroscopic surgery.
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.
The patients who receive BrostrÖm surgery.
Procedure: 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.
- AOFAS ankle-hindfoot score [ Time Frame: At 12 months after surgery ]
- Visual Analog Scale for Pain [ Time Frame: 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 [ Time Frame: At 12 months after surgery ]
- Complications [ Time Frame: At 12 months after surgery ]Wound infection, recurrence of ankle instability, ankle arthritis, rupture of anterior talofibular ligament.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736238
|Peking University People's Hospital|