The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL

NCT05196906 | Recruiting

• 1 other identifier: M2021565
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.

Conditions

Ankle Sprains; Instability, Joint; Joint Hypermobility

Keywords

chronic lateral ankle instability; generalized joint laxity; re-injury; modified Brostrom operation; anatomic reconstruction

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.

Other Outcomes (4)

• Rate of re-injury

  the rate of re-injury at 2 years.

• Signal to noise value of the anterior talofibular ligament

  6 months post-treatment

• Signal to noise value of the anterior talofibular ligament

  12 months post-treatment

Study Arms (2)

Modified Broström operation group

Patients who accept a modified Broström operation

Procedure: Modified Broström operation and anatomic reconstruction operation

Anatomic reconstruction operation group

Patients who accept an anatomic reconstruction

Procedure: Modified Broström operation and anatomic reconstruction operation

Interventions

Modified Broström operation and anatomic reconstruction operation PROCEDURE

Patients with CLAI and GJL will accept the Modified Broström operation or anatomic reconstruction operation.

Anatomic reconstruction operation group; Modified Broström operation group

Eligibility Criteria

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

Study Population

The patients who go to visit a doctor for persistent lateral ankle pain and instability over three months and invalid conservative treatment, with the age of 16- 50 years. If the Beighton score of the patient is ≥4 and the exclusion criteria are met, he or she is going to be advised to participate in this study.

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

RECRUITING

Related 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.

  PMID: 21833947 BACKGROUND

• Michels F, Cordier G, Guillo S, Stockmans F; ESKKA-AFAS Ankle Instability Group. Endoscopic Ankle Lateral Ligament Graft Anatomic Reconstruction. Foot Ankle Clin. 2016 Sep;21(3):665-80. doi: 10.1016/j.fcl.2016.04.010.

  PMID: 27524711 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

MeSH Terms

Conditions

Ankle Injuries; Joint Instability; Reinjuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Dong Jiang, MD

  Peking University Third Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Jiang, MD

CONTACT

13811280948; bysyjiangdong@126.com

Anhong Wang, MD

CONTACT

18501325799; 1811210533@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: January 19, 2022
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)