Pain Evaluation After Anterior Cruciate Ligament (ACL) Ligamentoplasty
Pain Evaluation After ACL Ligamentoplasty: "All-inside" Versus Classical Technique. A Prospective Randomised Comparative Study
1 other identifier
interventional
46
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFebruary 9, 2015
February 1, 2015
1 year
October 4, 2011
February 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain assessment on a Visual Analogical Scale
One month after surgery
Secondary Outcomes (5)
Pain assessment on a Visual Analogical Scale
First ten days
Analgesics consumption
First ten days
Functional evaluation with IKDC score
Change from base-line in IKDC objective score at 6 months
Discharge of crutches and orthesis
Time frame from surgery
Radiographic analysis of tunnels positioning according to Aglietti's criteria
One month after surgery
Study Arms (2)
All-inside technique
EXPERIMENTALClassical technique
ACTIVE COMPARATORInterventions
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.
The Classical technique is a usual procedure for anterior cruciate ligament reconstruction (ACL). The fixation is achieved with interference screws.
Eligibility Criteria
You may qualify if:
- Total or partial tear of the Anterior Cruciate Ligament
You may not qualify if:
- Patient refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ambroise Paré Hospital
Boulogne-Billancourt, Île-de-France Region, 92100, France
Related Publications (1)
Benea H, d'Astorg H, Klouche S, Bauer T, Tomoaia G, Hardy P. Pain evaluation after all-inside anterior cruciate ligament reconstruction and short term functional results of a prospective randomized study. Knee. 2014 Jan;21(1):102-6. doi: 10.1016/j.knee.2013.09.006. Epub 2013 Oct 5.
PMID: 24269603DERIVED
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician Responsible of Clinical Research
Study Record Dates
First Submitted
October 4, 2011
First Posted
October 7, 2011
Study Start
November 1, 2010
Primary Completion
November 1, 2011
Study Completion
April 1, 2012
Last Updated
February 9, 2015
Record last verified: 2015-02