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

August 16, 2023 updated by: Ludwig Andre Pontoh, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Faculty of Medicine Universitas Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Single bundle group
Procedure: ACL reconstruction
performed arthroscopically
Active Comparator: Group 2
Double bundle only group
Procedure: ACL reconstruction
performed arthroscopically
Experimental: Group 3
Double bundle with lateral release group
Procedure: ACL reconstruction
performed arthroscopically

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTTG value
Time Frame: 6 months
tibial tuberosity to trochlea groove, radiographic outcome
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kujala score
Time Frame: 6 months
functional outcome
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

August 16, 2023

First Submitted That Met QC Criteria

August 16, 2023

First Posted (Actual)

August 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 22, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP/2019/003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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