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

Primary Purpose

ACL Injury

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
ACL reconstruction
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Single bundle group

Double bundle only group

Double bundle with lateral release group

Outcomes

Primary Outcome Measures

TTTG value
tibial tuberosity to trochlea groove, radiographic outcome

Secondary Outcome Measures

Kujala score
functional outcome

Full Information

First Posted
August 16, 2023
Last Updated
August 16, 2023
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT06004297
Brief Title
Influence of Combined Double-Bundle ACL Reconstruction With Lateral Retinacular Release to Prevent Patellofemoral Malalignment in Isolated ACL Rupture
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Single bundle group
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Double bundle only group
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Double bundle with lateral release group
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction
Intervention Description
performed arthroscopically
Primary Outcome Measure Information:
Title
TTTG value
Description
tibial tuberosity to trochlea groove, radiographic outcome
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Kujala score
Description
functional outcome
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Medicine Universitas Indonesia
City
Jakarta
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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