NCT06575543

Brief Summary

Our research is to evaluate the position and length of femoral tunnel, and to examine whether knee stability and clinical functional outcomes are better while using two-portal or three-portal technique .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

August 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

August 24, 2024

Last Update Submit

August 29, 2024

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (1)

  • Ct evaluation

    3D CT scan have been used to evaluate the tunnels location after ACL reconstruction, as they can provide excellent perspective of the tunnel aperture, good visualization of bony structure and shape of the intercondylar notch, that preclude the use of a conventional 2-dimensional CT scan for measurement of the ACL tunnels location

    1 day after surgery

Secondary Outcomes (1)

  • Clinical Examination & Functional scores

    at least 2 years after surgery

Study Arms (2)

2 portal group

The conventional 2-portal technique uses the anterolateral portal as the viewing portal and the anteromedial portal as the working portal

Radiation: CT

3 portal group

the 3-portal technique allows interchangeable use of the portals as a viewing and working portals depending on the specific task that is being performed

Radiation: CT

Interventions

CTRADIATION

3D CT scan have been used to evaluate the tunnels location after ACL reconstruction, as they can provide excellent perspective of the tunnel aperture, good visualization of bony structure and shape of the intercondylar notch, that preclude the use of a conventional 2-dimensional CT scan for measurement of the ACL tunnels location

2 portal group3 portal group

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Postoperative evaluation of patients who had previous ACL reconstruction (within terms of inclusion criteria \& study sample ) by ct , clinical examination and functional scores .

You may qualify if:

  • Age ( 16 - 50 ) .
  • Isolated ACL tear with or without meniscal inj
  • Patient who have undergone ACL reconstruction in the last 5 years in Arthroscopy and sports injuries unit .

You may not qualify if:

  • Age ( \< 16 ) 2- Patient with multi ligamentous inj . 3- Revision ACL tear .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (5)

  • Lohmander LS, Ostenberg A, Englund M, Roos H. High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum. 2004 Oct;50(10):3145-52. doi: 10.1002/art.20589.

    PMID: 15476248BACKGROUND

  • Bedi A, Altchek DW. The "footprint" anterior cruciate ligament technique: an anatomic approach to anterior cruciate ligament reconstruction. Arthroscopy. 2009 Oct;25(10):1128-38. doi: 10.1016/j.arthro.2009.03.008. Epub 2009 Aug 22.

    PMID: 19801292BACKGROUND

  • van Eck CF, Schreiber VM, Liu TT, Fu FH. The anatomic approach to primary, revision and augmentation anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2010 Sep;18(9):1154-63. doi: 10.1007/s00167-010-1191-4. Epub 2010 Jun 9.

    PMID: 20532865BACKGROUND

  • Nikolaou VS, Efstathopoulos N, Sourlas I, Pilichou A, Papachristou G. Anatomic double-bundle versus single-bundle ACL reconstruction: a comparative biomechanical study in rabbits. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):895-906. doi: 10.1007/s00167-009-0754-8. Epub 2009 Mar 17.

    PMID: 19290508BACKGROUND

  • Snow M, Stanish WD. Double-bundle ACL reconstruction: how big is the learning curve? Knee Surg Sports Traumatol Arthrosc. 2010 Sep;18(9):1195-200. doi: 10.1007/s00167-010-1062-z. Epub 2010 Feb 6.

    PMID: 20140602BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Mostafa Almeldien Mohamed, master degree

CONTACT

0884695376zalatawe@gmail.com

Mohamed Ali Masoud, lecturer

CONTACT

+201092698830Masoud.ortho@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 24, 2024

First Posted

August 28, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations

EG(1)