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Investigators designed this randomized controlled trial to compare the clinical outcomes of open and arthroscopic modified Broström operation for the treatment of CLAI and GJL.
The open modified Broström operation is the first line to treat chronic lateral ligament instability (CLAI). Arthroscopic techniques gain popularity for less invasivity, quick recovery to normal and sports activities, and the possibility to treat other intraarticular disorders. Studies have shown significantly poor clinical and radiological outcomes and a higher rate of failure in patients with generalized joint laxity (GJL) than patients without after open modified Broström operation. However, there is no study to compare the open and arthroscopic modified Brostrom operation for patients with GJL and CLAI. So, investigators designed this randomized controlled trial. The primary outcomes are Karlsson, American Orthopaedic Foot & Ankle Society, and visual analogue scales. 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 |
|---|---|---|---|
| Open Modified Broström operation group | Active Comparator | Patients who accept an open modified Broström operation |
|
| Arthroscopic Modified Broström operation group | Active Comparator | Patients who accept an arthroscopic modified Broström operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open or arthroscopic Modified Broström operation | Procedure | Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström 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 |
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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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| Name | Affiliation | Role |
|---|---|---|
| Dong Jiang, MD | Peking University Third Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21833947 | Background | 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. | |
| 30893238 | Background | 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. |
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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 |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Randomization was achieved using the opaque sealed envelopes, and each eligible patient was allocated to open or arthroscopic MBP in a 1:1 ratio with a random block assignment of 4 or 6. The envelopes were thoroughly shuffled and sequentially numbered and then opened before surgery. Patients were allowed to withdraw from this experiment.
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| 27496909 | Background | 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 | Background | 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. |
| 28394631 | Background | Li H, Hua Y, Li H, Ma K, Li S, Chen S. Activity Level and Function 2 Years After Anterior Talofibular Ligament Repair: A Comparison Between Arthroscopic Repair and Open Repair Procedures. Am J Sports Med. 2017 Jul;45(9):2044-2051. doi: 10.1177/0363546517698675. Epub 2017 Apr 10. |
| 37162539 | Derived | Wang AH, Su T, Jiang YF, Zhu YC, Jiao C, Hu YL, Guo QW, Jiang D. Arthroscopic modified Brostrom procedure achieved similar favorable short term outcomes to open procedure for chronic lateral ankle instability cases with generalized joint laxity. Knee Surg Sports Traumatol Arthrosc. 2023 Sep;31(9):4043-4051. doi: 10.1007/s00167-023-07431-x. Epub 2023 May 10. |