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NCT05698446 Clinical Trial

Comparison of MBR + Suture Tape and Anatomic Reconstruction for CLAI in GJL Cases: A Prospective Cohort Study

Ankle Sprains Clinical Trial

Official title:
Comparison of Modified Broström Repair + Suture Tape and Anatomic Reconstruction for CLAI in Chronic Lateral Ankle Instability in Generalized Joint Laxity Cases: A Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05698446
Other study ID # M2022514
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date June 1, 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
Health authority
Study type Observational

Clinical Trial Summary

GJL is a risk factor for postoperative recurrent instability following an MBR for CLAI. BPR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Description:

Generalized joint laxity (GJL) is a risk factor for postoperative recurrent instability following an open modified Broström repair (MBR) for chronic lateral ankle instability (CLAI). MBR with suture tape augmentation and anatomic reconstruction may provide more strength and stability. However, BPR with suture tape augmentation may lead to rejection of the suture tape, while anatomic reconstruction may be associated with more trauma. In addition, the outcomes between the BPR with suture tape augmentation and anatomic reconstruction were unknown.

Recruitment information / eligibility
Status Recruiting
Enrollment 86
Est. completion date June 1, 2025
Est. primary completion date June 1, 2023
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Modified Broström + Suture tape augmentation operation
Patients with CLAI and GJL will accept the Modified Broström + Suture tape augmentation operation
• Anatomic reconstruction operation
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)

Cho BK, Park JK, Choi SM, SooHoo NF. A randomized comparison between lateral ligaments augmentation using suture-tape and modified Brostrom repair in young female patients with chronic ankle instability. Foot Ankle Surg. 2019 Apr;25(2):137-142. doi: 10.1016/j.fas.2017.09.008. Epub 2017 Oct 18. — View Citation

Lan R, Piatt ET, Bolia IK, Haratian A, Hasan L, Peterson AB, Howard M, Korber S, Weber AE, Petrigliano FA, Tan EW. Suture Tape Augmentation in Lateral Ankle Ligament Surgery: Current Concepts Review. Foot Ankle Orthop. 2021 Oct 20;6(4):24730114211045978. doi: 10.1177/24730114211045978. eCollection 2021 Oct. — View Citation

Michels F, Cordier G, Burssens A, Vereecke E, Guillo S. Endoscopic reconstruction of CFL and the ATFL with a gracilis graft: a cadaveric study. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1007-14. doi: 10.1007/s00167-015-3779-1. Epub 2015 Sep 26. — 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: 10.2106/JBJS.18.00458. No abstract available. — 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
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