The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL

Ankle Sprains Clinical Trial

Official title:

The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05284188
• Other study ID #: M2021052
• Status: Completed
• Phase: N/A
• Start date: January 8, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2018
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Instability, Joint
• Joint Hypermobility
• Joint Instability

Intervention

Procedure:
• Open or arthroscopic Modified Broström operation
Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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;(8):CD004124. doi: 10.1002/14651858.CD004124.pub3. Review. — View Citation

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. — View Citation

Park KH, Lee JW, Suh JW, Shin MH, Choi WJ. Generalized Ligamentous Laxity Is an Independent Predictor of Poor Outcomes After the Modified Broström Procedure for Chronic Lateral Ankle Instability. Am J Sports Med. 2016 Nov;44(11):2975-2983. Epub 2016 Aug 1. — View Citation

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. Review. — View Citation

Xu HX, Lee KB. Modified Broström Procedure for Chronic Lateral Ankle Instability in Patients With Generalized Joint Laxity. Am J Sports Med. 2016 Dec;44(12):3152-3157. Epub 2016 Aug 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Karlsson score	This score is a primary scale for lateral ankle instability	postoperative Karlsson score at 1 year
Primary	Karlsson score	This score is a primary scale for lateral ankle instability	postoperative Karlsson score at 2 years
Secondary	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