Outcome and Tunnel Widening After ACL Reconstruction: Comparison of Aperture and Cortical Fixation
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|ClinicalTrials.gov Identifier: NCT01755819|
Recruitment Status : Unknown
Verified January 2013 by Dr. René El Attal, Medical University Innsbruck.
Recruitment status was: Recruiting
First Posted : December 24, 2012
Last Update Posted : January 16, 2013
Failure of graft incorporation and tunnel widening (TW) after anterior cruciate ligament (ACL) reconstruction has been frequently reported in the literature. The etiology of TW is still not fully understood.
Patients and Methods:
This is a prospective randomized study including 60 patients, conducted in a Level I trauma center in Innsbruck, Austria. The study protocol was approved by the hospital ethics committee. This study is planned and conducted following the Consolidated Standards on Reporting Trials (CONSORT) guidelines. Aperture fixation is performed using BioComposite interference screws (Arthrex, Naples, FL). Extracortical fixation is performed using the ACL Tightrope (Arthrex, Naples, FL). TW is measured on CT scan postoperative, after 6 and 24 months. Clinical outcome is determined at 1, 2 after reconstruction, IKDC with KOOS Knee-related QoL subscale, Lysholm, Tegner Activity scores, hop tests and KT-1000 measurements are performed.
The purpose of this randomized controlled trail is to determine the influence of two different fixation methods on TW and clinical outcome after anatomic ACL reconstruction using hamstring graft in young and active patients.
|Condition or disease||Intervention/treatment||Phase|
|ACL Anterior Cruciate Ligament Injury Outcome||Device: Biocomposite interference screw Device: Extracortical ACL Tightrope fixation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Outcome and Tunnel Widening After Hamstring Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Computed Tomography - Based Trial Comparing Aperture With Cortical Fixation|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2016|
Biocomposite interference screw
Thirty patients treated with ACL reconstruction and graft fixation is performed using Biocomposite interference screw on tibial and femoral side. Patients are randomized to one of the two study arms.
Device: Biocomposite interference screw
Extracortical ACL Tightrope fixation
Thirty patients treated with ACL reconstruction and graft fixation is performed using extracortical ACL Tightrope fixation on tibial and femoral side. Patients are randomized to one of the two study arms.
Device: Extracortical ACL Tightrope fixation
- Change of tunnel volume and diameter from baseline up to 2 year follow up [ Time Frame: 1-2 days before (knee) operation, 6 months FU, 2 year FU ]CT tunnel measurements are conducted. Tunnel volume are calculated by CT volumetry measured in mm³ and tunnel diameter is measured in mm.
- Clinical outcome: international knee score evaluating objective and subjective knee outcome variables [ Time Frame: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU ]
Clinical outcome measured by IKDC (INTERNATIONAL KNEE DOCUMENTATION COMMITTEE) Subjective questionnaire (symptoms, sports activity, knee function): scaled from 0-100.
Objective evaluation form (radiological assessment of cartilage and menisci, functional knee examination, range of motion): scaled A-D
- Clinical outcome: influence on quality of life after knee ACL reconstruction [ Time Frame: 1-2 days before (knee)operation, 6 month FU, 1 year FU, 2year FU ]Clinical outcome measured by KOOS Knee related QoL subscale
- Clinical outcome: subjective evaluation of knee function [ Time Frame: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU ]Clinical outcome measured by Lysholm Score: subjective questionnaire
- Clinical outcome: return to sports activity [ Time Frame: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU ]Clinical outcome measured by Tegner Activity scores: sports activity level
- Clinical outcome: strength in single leg jumping after ACL reconstruction [ Time Frame: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU ]Single leg hop test measured in cm. Comparing the injured and healthy knee.
- Clinical outcome: objective knee anterior stability [ Time Frame: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU ]Clinical outcome measured by KT1000 arthrometer measurements in mm.
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): NCT01755819
|Contact: Rene EL Attal, Dr.||firstname.lastname@example.org|
|Principal Investigator:||Rene El Attal, Dr.||Medical University Innsbruck (Traumasurgery)|