Comparison of MBR + Suture Tape and MBR for CLAI : A Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Modified Broström procedure + Suture tape augmentation operation, Modified Broström procedure operation.
- Who it may be relevant to
- Registry conditions: Ankle Sprain, Hypermobility, Joint. Basic parameters: 15 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Modified Broström Repair + Suture Tape and Modified Broström Repair for Chronic Lateral Ankle Instability : A Prospective Cohort Study
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.
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.
Interventions
- Procedure Modified Broström procedure + Suture tape augmentation operation
Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation - Procedure Modified Broström procedure operation
Patients with CLAI and GJL will accept the Modified Broström procedure operation
Primary outcome measures
- The American Orthopaedic Foot and Ankle Society (AOFAS) score [Time frame: postoperative AOFAS score at 1 year]
- The American Orthopaedic Foot and Ankle Society (AOFAS) score [Time frame: postoperative AOFAS score at 2 years]
- The American Orthopaedic Foot and Ankle Society (AOFAS) score [Time frame: postoperative AOFAS score at 6 months]
- The American Orthopaedic Foot and Ankle Society (AOFAS) score [Time frame: postoperative AOFAS score at 3 months]
Secondary outcome measures (2)
- Anterior displacement and talar tilt angle in stress radiography [Time frame: postoperative radiographic measures at 2 years]
- Rate of re-injury [Time frame: the rate of re-injury at 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Publications
- 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. PMID 34252562
- 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. PMID 27496909
Identifiers
NCT: NCT06897293 · M2024292