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, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier:
NCT01588977
First received: April 27, 2012
Last updated: November 14, 2013
Last verified: November 2013
  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 Hôpital Européen Marseille:

Primary Outcome Measures:
  • Subchondral microfracture of tibia on MRI [ Time Frame: 2 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain on Visual Analogue Scale [ Time Frame: During two days after surgery, twice a day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Hôpital Européen Marseille
  More Information

No publications provided

Responsible Party: Shahnaz Klouche, MD, Physician Clinical Research, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier: NCT01588977     History of Changes
Other Study ID Numbers: APR042012
Study First Received: April 27, 2012
Last Updated: November 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 23, 2014