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

NCT ID: NCT05284188

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-08

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Sprains Instability, Joint Joint Hypermobility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open Modified Broström operation group

Patients who accept an open modified Broström operation

Group Type ACTIVE_COMPARATOR

Open or arthroscopic Modified Broström operation

Intervention Type PROCEDURE

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

Arthroscopic Modified Broström operation group

Patients who accept an arthroscopic modified Broström operation

Group Type ACTIVE_COMPARATOR

Open or arthroscopic Modified Broström operation

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open or arthroscopic Modified Broström operation

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jiang Dong

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dong Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hosptial

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Third Hospital

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21833947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30893238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27496909 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27480980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28394631 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37162539 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M2021052

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.