NCT02633410

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

8 years

First QC Date

December 15, 2015

Last Update Submit

December 16, 2015

Conditions

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

  • Anterior cruciate ligament quality of life

    24-months postoperative

Secondary Outcomes (2)

  • KT-1000

    24-months post-operative

  • Knee range of motion

    24-months post-operative

Study Arms (2)

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

Femoral tunnel creationPROCEDURE

Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned

AnteromedialTranstibial

Eligibility Criteria

Age14 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Peter MacDonald, MD FRCSC

    Pan Am CLinic/University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 17, 2015

Study Start

July 1, 2007

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 17, 2015

Record last verified: 2015-12