NCT02754674

Brief Summary

  • Double bundle transportal technique with flexible reamer: 33
  • Single bundle outside in technique with remnant preservation: 33

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 28, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 20, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2017

Enrollment Period

Same day

First QC Date

February 22, 2015

Results QC Date

May 7, 2019

Last Update Submit

December 3, 2019

Conditions

Rupture of Anterior Cruciate Ligament

Outcome Measures

Primary Outcomes (1)

  • Vascularity of Graft Tendon

    For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.

    1yr after surgery

Secondary Outcomes (4)

  • Arthroscopy Grading

    1yr after surgery

  • Clinical Knee Scoring

    2 yr after surgery

  • Instability

    2 yr after surgery

  • Graft Maturity (SNQ)

    1 yr after surgery

Study Arms (2)

Transportal

EXPERIMENTAL

this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique

Procedure: type of anterior cruciate ligament reconstruction

Outside in

EXPERIMENTAL

this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique

Procedure: type of anterior cruciate ligament reconstruction

Interventions

type of anterior cruciate ligament reconstructionPROCEDURE

comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation

Outside inTransportal

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Lachman test grade II,III and Pivot shift test grade II,III in physical examination
  • ACL rupture in MRI
  • Age 20\~60
  • within 6 months after trauma

You may not qualify if:

  • osteoarthritis (OA) change in X-ray
  • History of other ligament injury or ACL reconstruction in uninjured knee.
  • operation history of either ipsilateral or contralateral knee(fracture, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Wang JH, Lee ES, Lee BH. Paradoxical tunnel enlargement after ACL reconstruction with hamstring autografts when using beta-TCP containing interference screws for tibial aperture fixation- prospectively comparative study. BMC Musculoskelet Disord. 2017 Sep 16;18(1):398. doi: 10.1186/s12891-017-1757-0.

    PMID: 28915914DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Limitations and Caveats

Technical problems with measurement leading to unreliable or uninterpretable data

Results Point of Contact

Title
Wang, JoonHo
Organization
Samsung Medical Center
mdwang88@gmail.com
82-2-3410-3507

Study Officials

  • Joon Ho Wang, MD, Ph D

    Samsung Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

February 22, 2015

First Posted

April 28, 2016

Study Start

May 1, 2014

Primary Completion

May 1, 2014

Study Completion

December 1, 2017

Last Updated

December 20, 2019

Results First Posted

December 20, 2019

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

if yes, age, sex, physical examination, trauma date, MRI.

Locations

KR(1)