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Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction

This study is currently recruiting participants.
Verified April 2012 by Hôpital Ambroise Paré
Sponsor:
Information provided by (Responsible Party):
Shahnaz Klouche, MD, Hôpital Ambroise Paré
ClinicalTrials.gov Identifier:
NCT01588977
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Hôpital Ambroise Paré:

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 ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: August 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588977

Contacts
Contact: Ronny Lopes, MD ronnybask@yahoo.fr

Locations
France
Ambroise Paré Hospital Recruiting
Boulogne-Billancourt, France, 92104
Principal Investigator: Philippe Hardy, PhD            
Hôtel-Dieu CHU Nantes Recruiting
Nantes, France, 44093
Contact: François Gouin, PhD            
Polyclinique de L'Europe Recruiting
Saint-Nazaire, France, 44600
Contact: Hubert Lanternier, MD            
Sponsors and Collaborators
Hôpital Ambroise Paré
  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: April 30, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 19, 2013