Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction

August 2, 2016 updated by: Shahnaz Klouche, MD, Hospital Ambroise Paré Paris

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boulogne-Billancourt, France, 92104
        • Ambroise Paré Hospital
      • Nantes, France, 44093
        • Hotel-Dieu CHU Nantes
      • Saint-Nazaire, France, 44600
        • Polyclinique de l'Europe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
All-Inside TightRope technique
ACL reconstruction with TLS system
Hamstring Tendon Graft Reconstruction of the ACL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Subchondral microfracture of tibia on MRI
Time Frame: 2 days after surgery
2 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain on Visual Analogue Scale
Time Frame: During two days after surgery, twice a day
During two days after surgery, twice a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ambroise Paré Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

April 27, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR042012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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