Clinical trial NCT06897293: Comparison of MBR + Suture Tape and MBR for CLAI in GJL Cases: A Prospective Cohort Study
Official title: Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Sprain
Hypermobility, Joint
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 86
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape. In addition, the outcomes of the MBP with suture tape augmentation were unknown.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of lateral ankle instability
* Beighton score ≥4
* Age with 18 to 60 years

Exclusion Criteria:

* 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
* Stage III or IV osteoarthritis
* Patients who refused to participate in the study

Primary outcomes:
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) score
timeFrame: postoperative AOFAS score at 1 year
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) score
timeFrame: postoperative AOFAS score at 2 years
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) score
timeFrame: postoperative AOFAS score at 6 months
measure: The American Orthopaedic Foot and Ankle Society (AOFAS) score
timeFrame: postoperative AOFAS score at 3 months
Secondary outcomes:
measure: Anterior displacement and talar tilt angle in stress radiography
timeFrame: postoperative radiographic measures at 2 years
measure: Rate of re-injury
timeFrame: the rate of re-injury at 2 years
Other outcomes:
measure: Signal to noise value of anterior talofibular ligament
timeFrame: 6 months post-treatment
measure: Signal to noise value of the anterior talofibular ligament
timeFrame: 12 months post-treatment
measure: Signal to noise value of the anterior talofubular ligament
timeFrame: 24 months post-treatment
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References:
citation: Wittig U, Hohenberger G, Ornig M, Schuh R, Reinbacher P, Leithner A, Holweg P. Improved Outcome and Earlier Return to Activity After Suture Tape Augmentation Versus Brostrom Repair for Chronic Lateral Ankle Instability? A Systematic Review. Arthroscopy. 2022 Feb;38(2):597-608. doi: 10.1016/j.arthro.2021.06.028. Epub 2021 Jul 9.
citation: Xu HX, Lee KB. Modified Brostrom Procedure for Chronic Lateral Ankle Instability in Patients With Generalized Joint Laxity. Am J Sports Med. 2016 Dec;44(12):3152-3157. doi: 10.1177/0363546516657816. Epub 2016 Aug 5.