Subchondral Microfracture of Tibia After Arthroscopic Ant... | NCT01588977

Studies
Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction

NCT01588977

Sponsor

Hospital Ambroise Paré Paris

Status

Completed

Last Update Posted

Aug 4, 2016Estimated

Enrollment

43Actual

Phase

Not provided

Conditions

Anterior Cruciate Ligament Reconstruction
Subchondral Microfractures of Tibia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jul 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Apr 27, 2012

First Submission Date that Met QC Criteria

Apr 30, 2012

First Posted Date

May 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2016

Last Update Posted Date

Aug 4, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shahnaz Klouche, MD, Physician Clinical Research, Hospital Ambroise Paré ParisPrincipal Investigator

Lead Sponsor

Hospital Ambroise Paré ParisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

43Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ambroise Paré Hospital		Boulogne-Billancourt		92104	France
Hôtel-Dieu CHU Nantes

Label	Type	Description	Intervention Names
All-Inside TightRope technique
ACL reconstruction with TLS system
Hamstring Tendon Graft Reconstruction of the ACL