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

Ankle Sprains Clinical Trial

Official title:

The Clinical Outcomes Comparing the Modified Broström vs Anatomic Reconstruction Operation in Chronic Lateral Ankle Instability and Generalized Joint Laxity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196906
• Other study ID #: M2021565
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Peking University Third Hospital
• Contact: Dong Jiang, MD
• Phone: 13811280948
• Email: bysyjiangdong[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Instability, Joint
• Joint Hypermobility
• Joint Instability

Intervention

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

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

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. — View 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: 10.1177/03 — View 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: 10.2 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of re-injury	After surgery, the rate of patients re-sprain	the rate of re-injury at 2 years.
Primary	Karlsson score	This score is a primary scale for lateral ankle instability	postoperative Karlsson score at 1 year.
Primary	Karlsson score	This score is a primary scale for lateral ankle instability	postoperative Karlsson score at 2 years.
Secondary	Anterior displacement and talar tilt angle in stress radiography	The outcomes are common indicators for evaluation the lateral stability of ankle	postoperative radiographic measures at 2 years.