Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shahnaz Klouche, MD, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier:
NCT01448278
First received: October 4, 2011
Last updated: April 6, 2012
Last verified: April 2012
  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: 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 Hôpital Européen Marseille:

Primary Outcome Measures:
  • Pain assessment on a Visual Analogical Scale [ Time Frame: One month after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain assessment on a Visual Analogical Scale [ Time Frame: First ten days ] [ Designated as safety issue: No ]
  • Analgesics consumption [ Time Frame: First ten days ] [ Designated as safety issue: No ]
  • Functional evaluation with IKDC score [ Time Frame: Change from base-line in IKDC objective score at 6 months ] [ Designated as safety issue: No ]
  • Discharge of crutches and orthesis [ Time Frame: Time frame from surgery ] [ Designated as safety issue: No ]
  • Radiographic analysis of tunnels positioning according to Aglietti's criteria [ Time Frame: One month after surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Total or partial tear of the Anterior Cruciate Ligament

Exclusion Criteria:

  • Patient refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448278

Locations
France
Ambroise Paré Hospital
Boulogne-Billancourt, Ile de France, France, 92100
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Philippe Hardy, Ph.D. Hôpital Européen Marseille
Study Director: Horea Benea, MD Ambroise Paré Hospital
Study Director: Henri d'Astorg, MD Ambroise Paré Hospital
  More Information

No publications provided by Hôpital Européen Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shahnaz Klouche, MD, Physician Responsible of Clinical Research, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier: NCT01448278     History of Changes
Other Study ID Numbers: APR112010
Study First Received: October 4, 2011
Last Updated: April 6, 2012
Health Authority: France: French Agency of Sanitary Safety of the Products of Health

Keywords provided by Hôpital Européen Marseille:
Anterior cruciate ligament
Arthroscopy
Incomplete bone tunnels
Anterior cruciate ligament reconstruction

ClinicalTrials.gov processed this record on September 18, 2014