Transtibial Versus Anteromedial Femoral Tunnel Technique... | NCT02633410

Studies
Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction

NCT02633410

Sponsor

Panam Clinic

Status

Completed

Last Update Posted

Dec 17, 2015Estimated

Enrollment

96Actual

Phase

Not Applicable

Conditions

Anterior Cruciate Ligament Reconstruction

Interventions

Femoral tunnel creation

Countries

Not provided

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

Dec 2015

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

Jul 2007

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Dec 16, 2015

First Posted Date

Dec 17, 2015Estimated

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

Dec 16, 2015

Last Update Posted Date

Dec 17, 2015Estimated

Name	Class
Unity Health Toronto	OTHER

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 anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Detailed Description

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transtibial	Active Comparator	Transtibial technique used to create femoral tunnel	Procedure: Femoral tunnel creation
Anteromedial	Active Comparator	Anteromedial technique used to create femoral tunnel	Procedure: Femoral tunnel creation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Femoral tunnel creation	Procedure	Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned	Anteromedial Transtibial

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anterior cruciate ligament quality of life		24-months postoperative

Secondary Outcomes

Measure	Description	Time Frame
KT-1000		24-months post-operative
Knee range of motion		24-months post-operative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention

Exclusion Criteria:

concomitant collateral ligament tears
significant chondromalacia (based on diagnostic imaging)
previous lower limb surgery
significant injury to either lower limb requiring surgery
history of arthritis
were unable to comply with rehabilitation protocols or study follow-ups
were pregnant females or had other medical conditions which precluded participation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter MacDonald, MD FRCSC	Pan Am CLinic/University of Manitoba	Principal Investigator

Locations

Not provided