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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05284188

Collaborator

(none)

Enrollment

Location

Arms

46.8

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Sprains Instability, Joint Joint Hypermobility	Procedure: Open or arthroscopic Modified Broström operation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 8, 2018

Actual Primary Completion Date :

Dec 1, 2020

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Open Modified Broström operation group Patients who accept an open modified Broström operation	Procedure: Open or arthroscopic Modified Broström operation Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.
Active Comparator: Arthroscopic Modified Broström operation group Patients who accept an arthroscopic modified Broström operation	Procedure: Open or arthroscopic Modified Broström operation Patients with CLAI and GJL were randomly allocated to accept the open or arthroscopic Modified Broström operation.

Arm

Intervention/Treatment

Active Comparator: Open Modified Broström operation group

Patients who accept an open modified Broström operation

Procedure: Open or arthroscopic Modified Broström operation

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

Active Comparator: Arthroscopic Modified Broström operation group

Patients who accept an arthroscopic modified Broström operation

Procedure: Open or arthroscopic Modified Broström operation

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

Outcome Measures

Primary Outcome Measures

Karlsson score [postoperative Karlsson score at 1 year]
This score is a primary scale for lateral ankle instability
Karlsson score [postoperative Karlsson score at 2 years]
This score is a primary scale for lateral ankle instability

Secondary Outcome Measures

Anterior displacement and talar tilt angle in stress radiography [postoperative radiographic measures at 2 years]
The outcomes are common indicators for evaluation the lateral stability of ankle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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