The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorPeking University Third Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Modified Broström operation and anatomic reconstruction operation
Procedure/SurgeryPatients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Modified Broström operation group1 intervention
Group B: Anatomic reconstruction operation group1 intervention
Trial outcomes
Primary outcomes
1
Karlsson score
This score is a primary scale for lateral ankle instability
Time frame
postoperative Karlsson score at 1 year.2
Karlsson score
This score is a primary scale for lateral ankle instability
Time frame
postoperative Karlsson score at 2 years.Secondary outcomes
1
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.Other outcomes
1
Rate of re-injury
After surgery, the rate of patients re-sprain
Time frame
the rate of re-injury at 2 years.2
Signal to noise value of the anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame
6 months post-treatment3
Signal to noise value of the anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame
12 months post-treatment4
Signal to noise value of the anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame
2 years post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov