Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique

NCT01513434 | Completed DMC

• 1 other identifier: NPH2008-004
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men.

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (2)

• Lysholm score

  Lysholm score was superior in transportal technique to transtibial technique.

  at least two years after surgery

• Position of femoral tunnel aperture

  The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.

  within one week after surgery

Study Arms (2)

transtibial technique

ACTIVE COMPARATOR

In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel.

Procedure: transtibial technique; Procedure: anterior cruciate ligament reconstruction

Transportal technique

ACTIVE COMPARATOR

In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal.

Procedure: Transportal technique; Procedure: anterior cruciate ligament reconstruction

Interventions

transtibial technique PROCEDURE

Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.

transtibial technique

Transportal technique PROCEDURE

Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.

Also known as: anteromedial portal technique

Transportal technique

anterior cruciate ligament reconstruction PROCEDURE

femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw

Transportal technique; transtibial technique

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosis of anterior cruciate ligament rupture

You may not qualify if:

• female
• over 45 years old
• the subjects who had ACL reconstruction with graft other than Achilles allograft
• the subjects who had concomitant other ligament injuries on the same knee needing surgical treatment
• revision ACL reconstruction
• double bundle ACL reconstruction
• concomitant full thickness cartilage injury needing cartilage repairing surgery

Sponsors & Collaborators

• National Police Hospital: lead

Study Sites (1)

National Police Hospital

Seoul, 138-708, South Korea

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: July 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

KR (1)