Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of 3 Techniques for Recreation of Anterior Cruciate Ligament Anatomic Footprint

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795247
Recruitment Status : Active, not recruiting
First Posted : June 10, 2016
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.

Brief Summary:
The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates the anterior cruciate ligament anatomic footprint.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Reconstruction Procedure: Anterior Cruciate Ligament Reconstruction Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Three Dimensional Computed Tomography Comparison of the Transtibial, Modified Transtibial and Anteromedial Portal Technique for Recreation of the Anterior Cruciate Ligament Anatomic Footprint
Actual Study Start Date : August 26, 2016
Actual Primary Completion Date : November 16, 2017
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Hybrid Transtibial Technique
Reconstruction of the ACL using the hybrid transtibial technique
Procedure: Anterior Cruciate Ligament Reconstruction
Other Name: ACL Reconstruction

Active Comparator: Accessory Anteromedial Portal Technique
Reconstruction of the ACL using the accessory anteromedial portal technique
Procedure: Anterior Cruciate Ligament Reconstruction
Other Name: ACL Reconstruction

Active Comparator: Transtibial Technique
Reconstruction of the ACL using the transtibial technique.
Procedure: Anterior Cruciate Ligament Reconstruction
Other Name: ACL Reconstruction




Primary Outcome Measures :
  1. 3D reconstructed CT imaging [ Time Frame: 6 weeks Post-Operatively ]
    Used to measure tunnel position.


Secondary Outcome Measures :
  1. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation [ Time Frame: 6 weeks post-operative ]
    Change in IKDC subjective knee evaluation since before surgery

  2. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 weeks post-operative ]
    Change in KOOS since before surgery

  3. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation [ Time Frame: 6 months post-operative ]
    Change in IKDC subjective knee evaluation since before surgery

  4. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 6 months post-operative ]
    Change in KOOS since before surgery

  5. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation [ Time Frame: 1 year post-operative ]
    Change in IKDC subjective knee evaluation since before surgery

  6. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 1 year post-operative ]
    Change in KOOS since before surgery

  7. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation [ Time Frame: 2 year post-operative ]
    Change in IKDC subjective knee evaluation since before surgery

  8. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 2 year post-operative ]
    Change in KOOS since before surgery

  9. Knee Laxity [ Time Frame: 6 month post-operatively ]
    Pivot shift test will be used to a measure of knee laxity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting for single bundle ACL reconstruction, with or without associated partial meniscectomy or meniscal repair.
  • Skeletally mature patients
  • Patients who are able and willing to receive post-operative CT imaging of the affected knee

Exclusion Criteria:

  • Previous ACL reconstruction in the studied knee
  • Previous ACL injury or reconstruction in the contralateral kneeConcomitant non-ACL ligament reconstruction or osteotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795247


Locations
Layout table for location information
United States, North Carolina
OrthoCarolina Sports Center
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Dana P Piasecki, MD OrthoCarolina Research Institute, Inc.
Publications:

Layout table for additonal information
Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02795247    
Other Study ID Numbers: SPORT037
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No