Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty
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.
|Arthroscopic Anterior Cruciate Ligament Reconstruction||Procedure: "All-inside" Procedure: Classical technique||Phase 4|
|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|
- Pain assessment on a Visual Analogical Scale [ Time Frame: One month after surgery ]
- 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 ]
|Study Start Date:||November 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Experimental: All-inside technique||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448278
|Ambroise Paré Hospital|
|Boulogne-Billancourt, Ile de France, France, 92100|
|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|