Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-55
SponsorPeking University Third Hospital
About this trial
GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. Additional suture tape augmentation has been suggested to provide more strength and stability. However, the outcomes of the MBP with suture tape augmentation were unknown, which requires further exploration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of lateral ankle instability
Beighton score ≥4
Age with 18 to 60 years
Disqualifiers
Patients with an acute or subacute ankle injury
Injury of the deltoid ligament
Alignment of lower extremity greater than 5 degrees
Fractures of the lower extremity
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 15 - 55 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 procedure + Suture tape augmentation operation
Procedure/SurgeryPatients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation
Modified Broström procedure operation
Procedure/SurgeryPatients with CLAI and GJL will accept the Modified Broström procedure operation
Treatment groups
86 Participants
are divided into 2 treatment groupsGroup A: Open Modified Broström +Suture tape augmentation group1 intervention
Group B: Open Modified Broström group1 intervention
Trial outcomes
Primary outcomes
1
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Time frame
postoperative AOFAS score at 1 year2
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Time frame
postoperative AOFAS score at 2 years3
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Time frame
postoperative AOFAS score at 6 months4
The American Orthopaedic Foot and Ankle Society (AOFAS) score
This score is a primary scale for lateral ankle instability, ranges from 0-100, and the higher of the score is associate with a better outcome.
Time frame
postoperative AOFAS score at 3 monthsSecondary outcomes
1
Anterior displacement and talar tilt angle in stress radiography
The outcomes are common indicators for evaluation the lateral stability of ankle, and can be evaluated through same stress radiography
Time frame
postoperative radiographic measures at 2 years2
Rate of re-injury
The rate of patients re-sprain after the surgery
Time frame
the rate of re-injury at 2 yearsOther outcomes
1
Signal to noise value of anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame
6 months post-treatment2
Signal to noise value of the anterior talofibular ligament
Signal to noise value of the anterior talofibular ligament
Time frame
12 months post-treatment3
Signal to noise value of the anterior talofubular ligament
Signal to noise value of the anterior talofibular ligament
Time frame
24 months post-treatmentSponsors and contacts
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Source ClinicalTrials.gov