Comparison of MBR + Suture Tape and MBR for CLAI in GJL Cases: A Prospective Cohort Study

Peking University Third Hospital86 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ankle Sprain Hypermobility, Joint

Interventions

Modified Broström procedure + Suture tape augmentation operationPROCEDURE

Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation

Modified Broström procedure operationPROCEDURE

Patients with CLAI and GJL will accept the Modified Broström procedure operation

Eligibility

Sex: ALLMin age: 15 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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 year

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 years

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 months

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 months

Secondary Outcomes

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 years

Rate of re-injury

The rate of patients re-sprain after the surgery

Time frame: the rate of re-injury at 2 years

Central Contacts

Dong Jiang, MD

CONTACT

13811280948 bysyjiangdong@126.com

Haoxuan Liu, MD

CONTACT

13716163357 2210301304@stu.pku.edu.cn

Data from ClinicalTrials.gov

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