An observational study in Ankle Sprains, Instability, Joint and Joint Hypermobility, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Peking University Third Hospital · Observational
Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.
The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
350 studies on the registry are indexed under Ankle Injuries; 74 are open to participants now.
This study's planned enrollment of 100 is above the median of 84 across 73 observational studies indexed under Ankle Injuries.
Browse Ankle Injuries studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The patients who go to visit a doctor for persistent lateral ankle pain and instability over three months and invalid conservative treatment, with the age of 16- 50 years. If the Beighton score of the patient is ≥4 and the exclusion criteria are met, he or she is going to be advised to participate in this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years
Exclusion Criteria:
Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study
Patients who accept a modified Broström operation
Procedure: Modified Broström operation and anatomic reconstruction operation
Patients who accept an anatomic reconstruction
Procedure: Modified Broström operation and anatomic reconstruction operation
Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation.
Karlsson score
This score is a primary scale for lateral ankle instability
Time frame: postoperative Karlsson score at 1 year.
Karlsson score
This score is a primary scale for lateral ankle instability
Time frame: postoperative Karlsson score at 2 years.
Anterior displacement and talar tilt angle in stress radiography
The outcomes are common indicators for evaluation the lateral stability of ankle
Time frame: postoperative radiographic measures at 2 years.
Rate of re-injury
After surgery, the rate of patients re-sprain
Time frame: the rate of re-injury at 2 years.
Signal to noise value of the anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame: 6 months post-treatment
Signal to noise value of the anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame: 12 months post-treatment
Signal to noise value of the anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame: 2 years post-treatment
Plan to share: No — The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
Started Jan 2020 (actual). Primary completion is estimated for Dec 2025, 71 months after the start.
Of 34 non-industry observational studies under Ankle Injuries, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's planned 71 months is above that.
Counting every sponsor, half of 38 studies reached it within 11 months; a quarter within 5 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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