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

NCT05284188 | Completed

• 1 other identifier: M2021052
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains; Instability, Joint; Joint Hypermobility

Keywords

chronic lateral ankle instability; generalized joint laxity; modified Brostrom operation; arthroscopic; open

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Anterior displacement and talar tilt angle in stress radiography

  postoperative radiographic measures at 2 years

Study Arms (2)

Open Modified Broström operation group

ACTIVE COMPARATOR

Patients who accept an open modified Broström operation

Procedure: Open or arthroscopic Modified Broström operation

Arthroscopic Modified Broström operation group

ACTIVE COMPARATOR

Patients who accept an arthroscopic modified Broström operation

Procedure: Open or arthroscopic Modified Broström operation

Interventions

Open or arthroscopic Modified Broström operation PROCEDURE

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

Arthroscopic Modified Broström operation group; Open Modified Broström operation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Related Publications (6)

• 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.

  PMID: 21833947 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.

  PMID: 30893238 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.

  PMID: 27496909 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.

  PMID: 27480980 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.

  PMID: 28394631 BACKGROUND

• 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.

  PMID: 37162539 DERIVED

MeSH Terms

Conditions

Ankle Injuries; Joint Instability

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Dong Jiang, MD

  Peking University Third Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: January 8, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: June 27, 2022

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)