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Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448278
First Posted: October 7, 2011
Last Update Posted: February 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
  Purpose

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.


Condition Intervention Phase
Arthroscopic Anterior Cruciate Ligament Reconstruction Procedure: "All-inside" Procedure: Classical technique Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study

Resource links provided by NLM:


Further study details as provided by Shahnaz Klouche, MD, Hospital Ambroise Paré Paris:

Primary Outcome Measures:
  • Pain assessment on a Visual Analogical Scale [ Time Frame: One month after surgery ]

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

Enrollment: 46
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total or partial tear of the Anterior Cruciate Ligament

Exclusion Criteria:

  • Patient refusal
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448278


Locations
France
Ambroise Paré Hospital
Boulogne-Billancourt, Ile de France, France, 92100
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shahnaz Klouche, MD, Physician Responsible of Clinical Research, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier: NCT01448278     History of Changes
Other Study ID Numbers: APR112010
First Submitted: October 4, 2011
First Posted: October 7, 2011
Last Update Posted: February 9, 2015
Last Verified: February 2015

Keywords provided by Shahnaz Klouche, MD, Hospital Ambroise Paré Paris:
Anterior cruciate ligament
Arthroscopy
Incomplete bone tunnels
Anterior cruciate ligament reconstruction