NCT06004297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

12 months

First QC Date

August 16, 2023

Last Update Submit

August 16, 2023

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

  • TTTG value

    tibial tuberosity to trochlea groove, radiographic outcome

    6 months

Secondary Outcomes (1)

  • Kujala score

    6 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Single bundle group

Procedure: ACL reconstruction

Group 2

ACTIVE COMPARATOR

Double bundle only group

Procedure: ACL reconstruction

Group 3

EXPERIMENTAL

Double bundle with lateral release group

Procedure: ACL reconstruction

Interventions

ACL reconstructionPROCEDURE

performed arthroscopically

Group 1Group 2Group 3

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • unilateral isolated total ACL rupture
  • normal BMI

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Universitas Indonesia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR., dr., Sp.OT(K)

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

January 7, 2019

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)