Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction

December 16, 2015 updated by: Panam Clinic

Prospective Randomized Clinical Study Comparing Anteromedial Portal Versus Transtibial Technique for Femoral Tunnel Positioning in Anterior Cruciate Ligament Reconstruction With Hamstring Autograft

The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

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

14 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention

Exclusion Criteria:

  • concomitant collateral ligament tears
  • significant chondromalacia (based on diagnostic imaging)
  • previous lower limb surgery
  • significant injury to either lower limb requiring surgery
  • history of arthritis
  • were unable to comply with rehabilitation protocols or study follow-ups
  • were pregnant females or had other medical conditions which precluded participation.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Transtibial
Transtibial technique used to create femoral tunnel
Procedure: Femoral tunnel creation
Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned
ACTIVE_COMPARATOR: Anteromedial
Anteromedial technique used to create femoral tunnel
Procedure: Femoral tunnel creation
Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anterior cruciate ligament quality of life
Time Frame: 24-months postoperative
24-months postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
KT-1000
Time Frame: 24-months post-operative
24-months post-operative
Knee range of motion
Time Frame: 24-months post-operative
24-months post-operative

Collaborators and Investigators

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

Sponsor

Panam Clinic

Collaborators

Unity Health Toronto

Investigators

  • Principal Investigator: Peter MacDonald, MD FRCSC, Pan Am CLinic/University of Manitoba

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

July 1, 2007

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (ESTIMATE)

December 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2015

Last Update Submitted That Met QC Criteria

December 16, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • ACL-FEM 01

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.

Clinical Trials on Anterior Cruciate Ligament Reconstruction

Clinical Trials on Femoral tunnel creation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe