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Completed

NCT Number: NCT01448278

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.

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Key information

Conditions

Arthroscopic Anterior Cruciate Ligament Reconstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ambroise Paré Hospital

Boulogne-Billancourt, Île-de-France Region, 92100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Total or partial tear of the Anterior Cruciate Ligament

Exclusion criteria

  • Patient refusal

Treatment and study plan

"All-inside"

Procedure

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.

Classical technique

Procedure

The Classical technique is a usual procedure for anterior cruciate ligament reconstruction (ACL). The fixation is achieved with interference screws.

Primary outcomes

  1. Pain assessment on a Visual Analogical Scale

    Time frame: One month after surgery

Secondary outcomes

  1. Pain assessment on a Visual Analogical Scale

    Time frame: First ten days

  2. Analgesics consumption

    Time frame: First ten days

  3. Functional evaluation with IKDC score

    Time frame: Change from base-line in IKDC objective score at 6 months

  4. Discharge of crutches and orthesis

    Time frame: Time frame from surgery

  5. Radiographic analysis of tunnels positioning according to Aglietti's criteria

    Time frame: One month after surgery

Sponsors and collaborators

Lead sponsor

Hospital Ambroise Paré Paris

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 7, 2011
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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