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Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01588977
First Posted: May 1, 2012
Last Update Posted: August 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shahnaz Klouche, MD, Hospital Ambroise Paré Paris
  Purpose
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.

Condition
Anterior Cruciate Ligament Reconstruction Subchondral Microfractures of Tibia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain

Resource links provided by NLM:


Further study details as provided by Shahnaz Klouche, MD, Hospital Ambroise Paré Paris:

Primary Outcome Measures:
  • Subchondral microfracture of tibia on MRI [ Time Frame: 2 days after surgery ]

Secondary Outcome Measures:
  • Pain on Visual Analogue Scale [ Time Frame: During two days after surgery, twice a day ]

Enrollment: 43
Study Start Date: April 2012
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
All-Inside TightRope technique
ACL reconstruction with TLS system
Hamstring Tendon Graft Reconstruction of the ACL

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588977


Locations
France
Ambroise Paré Hospital
Boulogne-Billancourt, France, 92104
Hôtel-Dieu CHU Nantes
Nantes, France, 44093
Polyclinique de L'Europe
Saint-Nazaire, France, 44600
Sponsors and Collaborators
Hospital Ambroise Paré Paris
  More Information

Responsible Party: Shahnaz Klouche, MD, Physician Clinical Research, Hospital Ambroise Paré Paris
ClinicalTrials.gov Identifier: NCT01588977     History of Changes
Other Study ID Numbers: APR042012
First Submitted: April 27, 2012
First Posted: May 1, 2012
Last Update Posted: August 4, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Fractures, Stress
Fractures, Bone
Wounds and Injuries