Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier:
NCT01588977
First received: April 27, 2012
Last updated: February 6, 2015
Last verified: February 2015

April 27, 2012
February 6, 2015
April 2012
July 2012   (final data collection date for primary outcome measure)
Subchondral microfracture of tibia on MRI [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01588977 on ClinicalTrials.gov Archive Site
Pain on Visual Analogue Scale [ Time Frame: During two days after surgery, twice a day ] [ Designated as safety issue: No ]
Same as current
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Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction
Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain
The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear
  • Anterior Cruciate Ligament Reconstruction
  • Subchondral Microfractures of Tibia
Not Provided
  • All-Inside TightRope technique
  • ACL reconstruction with TLS system
  • Hamstring Tendon Graft Reconstruction of the ACL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
August 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear

Exclusion Criteria:

  • previous reconstruction of ACL
  • associated lesions (meniscal tear, other ligament...)
  • Refusal consent
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01588977
APR042012
No
Not Provided
Not Provided
Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
Hospital Ambroise Paré Paris
Not Provided
Not Provided
Hospital Ambroise Paré Paris
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP