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

Primary Purpose

Ankle Sprains, Instability, Joint, Joint Hypermobility

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Open or arthroscopic Modified Broström operation
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprains focused on measuring chronic lateral ankle instability, generalized joint laxity, modified Brostrom operation, arthroscopic, open

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open Modified Broström operation group

Arthroscopic Modified Broström operation group

Arm Description

Patients who accept an open modified Broström operation

Patients who accept an arthroscopic modified Broström operation

Outcomes

Primary Outcome Measures

Karlsson score
This score is a primary scale for lateral ankle instability
Karlsson score
This score is a primary scale for lateral ankle instability

Secondary Outcome Measures

Anterior displacement and talar tilt angle in stress radiography
The outcomes are common indicators for evaluation the lateral stability of ankle

Full Information

First Posted
March 9, 2022
Last Updated
June 21, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05284188
Brief Title
The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL
Official Title
The Clinical Outcomes Comparing Open and Arthroscopic Modified Broström Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 8, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains, Instability, Joint, Joint Hypermobility
Keywords
chronic lateral ankle instability, generalized joint laxity, modified Brostrom operation, arthroscopic, open

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
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.
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Modified Broström operation group
Arm Type
Active Comparator
Arm Description
Patients who accept an open modified Broström operation
Arm Title
Arthroscopic Modified Broström operation group
Arm Type
Active Comparator
Arm Description
Patients who accept an arthroscopic modified Broström operation
Intervention Type
Procedure
Intervention Name(s)
Open or arthroscopic Modified Broström operation
Intervention Description
Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.
Primary Outcome Measure Information:
Title
Karlsson score
Description
This score is a primary scale for lateral ankle instability
Time Frame
postoperative Karlsson score at 1 year
Title
Karlsson score
Description
This score is a primary scale for lateral ankle instability
Time Frame
postoperative Karlsson score at 2 years
Secondary Outcome Measure Information:
Title
Anterior displacement and talar tilt angle in stress radiography
Description
The outcomes are common indicators for evaluation the lateral stability of ankle
Time Frame
postoperative radiographic measures at 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Jiang, MD
Organizational Affiliation
Peking University Third Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The demographics data, Beighton score, primary and secondary outcomes would be available to other researchers
Citations:
PubMed Identifier
21833947
Citation
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.
Results Reference
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PubMed Identifier
30893238
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. No abstract available.
Results Reference
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PubMed Identifier
27496909
Citation
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.
Results Reference
background
PubMed Identifier
27480980
Citation
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.
Results Reference
background
PubMed Identifier
28394631
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.
Results Reference
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The Clinical Outcomes of the Arthroscopic and Open Modified Broström Operation in CLAI and GJL

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