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NCT06004297 Clinical Trial

Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture

ACL Injury Clinical Trial

Official title:
Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06004297
Other study ID # AP/2019/003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 7, 2019
Est. completion date December 20, 2019

Study information
Verified date August 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anterior knee pain which might be due to patellofemoral malalignment is an inevitable post operative complication after an ACL reconstruction (ACLR). We combined the double bundle ACLR technique with lateral release technique to prevent patellofemoral malalignment post ACLR.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date December 20, 2019
Est. primary completion date December 20, 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 40 Years
Eligibility Inclusion Criteria: - unilateral isolated total ACL rupture - normal BMI Exclusion Criteria: - flexion contracture more than 200, presence of anterior knee pain before surgery, Q angle >140 in males and >170 in females, presence of a patellar tilting, rupture of other ligaments, and muscular dysfunction.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ACL reconstruction
performed arthroscopically

Locations
Country Name City State
Indonesia Faculty of Medicine Universitas Indonesia Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary TTTG value tibial tuberosity to trochlea groove, radiographic outcome 6 months
Secondary Kujala score functional outcome 6 months
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