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

NCT ID: NCT06004297

Last Updated: 2023-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2019-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group 1

Single bundle group

Group Type ACTIVE_COMPARATOR

ACL reconstruction

Intervention Type PROCEDURE

performed arthroscopically

Group 2

Double bundle only group

Group Type ACTIVE_COMPARATOR

ACL reconstruction

Intervention Type PROCEDURE

performed arthroscopically

Group 3

Double bundle with lateral release group

Group Type EXPERIMENTAL

ACL reconstruction

Intervention Type PROCEDURE

performed arthroscopically

Interventions

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ACL reconstruction

performed arthroscopically

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Ludwig Andre Pontoh

DR., dr., Sp.OT(K)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Universitas Indonesia

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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AP/2019/003

Identifier Type: -

Identifier Source: org_study_id

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