Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty

February 6, 2015 updated by: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study

The "All-inside" method is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation. In the so-called "classical" method, the fixation is achieved with interference screws.

The hypothesis of this study was that the "All-inside" technique causes less pain than the conventional technique. The main objective was to evaluate the immediate postoperative pain for the first ten days and at one month from the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Boulogne-Billancourt, Ile de France, France, 92100
        • Ambroise Paré Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Total or partial tear of the Anterior Cruciate Ligament

Exclusion Criteria:

  • Patient refusal

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All-inside technique
Procedure: "All-inside"
The "All-inside" technique is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation.
Active Comparator: Classical technique
Procedure: Classical technique
The Classical technique is a usual procedure for anterior cruciate ligament reconstruction (ACL). The fixation is achieved with interference screws.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain assessment on a Visual Analogical Scale
Time Frame: One month after surgery
One month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain assessment on a Visual Analogical Scale
Time Frame: First ten days
First ten days
Analgesics consumption
Time Frame: First ten days
First ten days
Functional evaluation with IKDC score
Time Frame: Change from base-line in IKDC objective score at 6 months
Change from base-line in IKDC objective score at 6 months
Discharge of crutches and orthesis
Time Frame: Time frame from surgery
Time frame from surgery
Radiographic analysis of tunnels positioning according to Aglietti's criteria
Time Frame: One month after surgery
One month after surgery

Collaborators and Investigators

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

Sponsor

Hospital Ambroise Paré Paris

Investigators

  • Principal Investigator: Philippe Hardy, Ph.D., Hospital Ambroise Paré Paris
  • Study Director: Horea Benea, MD, Ambroise Paré Hospital
  • Study Director: Henri d'Astorg, MD, Ambroise Paré Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 7, 2011

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 6, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • APR112010

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.

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