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

Study Overview
=================
Brief Summary
-----------------
GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

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 and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Official Title
-----------------
Comparison of Modified Broström Repair + Suture Tape and Anatomic Reconstruction for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study

Conditions
-----------------
Ankle Sprains, Hypermobility Syndrome

Intervention / Treatment
-----------------
* Procedure: Modified Broström + Suture tape augmentation operation
* Procedure: Anatomic reconstruction operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years Exclusion Criteria: Patients with an acute or subacute ankle injury (within 3 months) 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Modified Broström +Suture tape augmentation group<br>Patients who accept a modified Broström +Suture tape augmentation operation | Procedure: Modified Broström + Suture tape augmentation operation<br>* Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation<br>|
| Anatomic reconstruction operation group<br>Patients who accept an anatomic reconstruction | Procedure: Anatomic reconstruction operation<br>* Anatomic reconstruction operation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karlsson score | This score is a primary scale for lateral ankle instability | postoperative Karlsson score at 1 year | 
| Karlsson score | This score is a primary scale for lateral ankle instability | postoperative Karlsson score at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior displacement and talar tilt angle in stress radiography | The outcomes are common indicators for evaluation the lateral stability of ankle | postoperative radiographic measures at 2 years |