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Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.
The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Broström operation group | Patients who accept a modified Broström operation |
| |
| Anatomic reconstruction operation group | Patients who accept an anatomic reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Broström operation and anatomic reconstruction operation | Procedure | Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of re-injury | After surgery, the rate of patients re-sprain | the rate of re-injury at 2 years. |
| Signal to noise value of the anterior talofibular ligament | Signal to noise value of the anterior talofibular ligament |
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
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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 16- 50 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Jiang, MD | Contact | 13811280948 | bysyjiangdong@126.com | |
| Anhong Wang, MD | Contact | 18501325799 | 1811210533@pku.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dong Jiang, MD | Peking University Third Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21833947 | Result | de Vries JS, Krips R, Sierevelt IN, Blankevoort L, van Dijk CN. Interventions for treating chronic ankle instability. Cochrane Database Syst Rev. 2011 Aug 10;2011(8):CD004124. doi: 10.1002/14651858.CD004124.pub3. | |
| 27524711 | Result | Michels F, Cordier G, Guillo S, Stockmans F; ESKKA-AFAS Ankle Instability Group. Endoscopic Ankle Lateral Ligament Graft Anatomic Reconstruction. Foot Ankle Clin. 2016 Sep;21(3):665-80. doi: 10.1016/j.fcl.2016.04.010. |
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The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D007593 | Joint Instability |
| D000083102 | Reinjuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 6 months post-treatment |
| Signal to noise value of the anterior talofibular ligament | Signal to noise value of the anterior talofibular ligament | 12 months post-treatment |
| Signal to noise value of the anterior talofibular ligament | Signal to noise value of the anterior talofibular ligament | 2 years post-treatment |
| 30893238 | Result | Sacks HA, Prabhakar P, Wessel LE, Hettler J, Strickland SM, Potter HG, Fufa DT. Generalized Joint Laxity in Orthopaedic Patients: Clinical Manifestations, Radiographic Correlates, and Management. J Bone Joint Surg Am. 2019 Mar 20;101(6):558-566. doi: 10.2106/JBJS.18.00458. No abstract available. |
| 27496909 | Result | 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. |
| 27480980 | Result | Park KH, Lee JW, Suh JW, Shin MH, Choi WJ. Generalized Ligamentous Laxity Is an Independent Predictor of Poor Outcomes After the Modified Brostrom Procedure for Chronic Lateral Ankle Instability. Am J Sports Med. 2016 Nov;44(11):2975-2983. doi: 10.1177/0363546516656183. Epub 2016 Aug 1. |