Outcome Clinical Trial
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
Background:
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.
Hypothesis:
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. The ACL injury can be either "isolated" or combined with one or several of the following injuries visualized on MRI and/or arthroscopy: - A meniscus tear that is either left untreated or treated with a partial resection - A small, stable meniscus tear treated with fixation, but fixation not interfering with the rehabilitation protocol - Cartilage changes verified on MRI with arthroscopically determine intact surface 2. A radiographic examination with normal joint status or combined with either one of the following finding: - A small avulsed fragment located laterally, usually described as a Second fracture - JSN grade 1 or osteophytes grade 1 as determined by the OARSI atlas (Altman et al. 1995) 3. Agreement to participate in the study and signed informed consent prior to inclusion. Exclusion Criteria: 1.Presence of one of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy: - An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol - Bi-compartmental extensive meniscus resection - A cartilage injury representing a full thickness loss down to bone - A total rupture of MCL/LCL as visualized on MRI |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Innsbruck (Traumasurgery) | Innsbruck | Tyrol |
Lead Sponsor | Collaborator |
---|---|
Medical University Innsbruck |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of tunnel volume and diameter from baseline up to 2 year follow up | CT tunnel measurements are conducted. Tunnel volume are calculated by CT volumetry measured in mm³ and tunnel diameter is measured in mm. | 1-2 days before (knee) operation, 6 months FU, 2 year FU | No |
Secondary | Clinical outcome: international knee score evaluating objective and subjective knee outcome variables | 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 |
1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU | No |
Secondary | Clinical outcome: influence on quality of life after knee ACL reconstruction | Clinical outcome measured by KOOS Knee related QoL subscale | 1-2 days before (knee)operation, 6 month FU, 1 year FU, 2year FU | No |
Secondary | Clinical outcome: subjective evaluation of knee function | Clinical outcome measured by Lysholm Score: subjective questionnaire | 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU | No |
Secondary | Clinical outcome: return to sports activity | Clinical outcome measured by Tegner Activity scores: sports activity level | 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU | No |
Secondary | Clinical outcome: strength in single leg jumping after ACL reconstruction | Single leg hop test measured in cm. Comparing the injured and healthy knee. | 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU | No |
Secondary | Clinical outcome: objective knee anterior stability | Clinical outcome measured by KT1000 arthrometer measurements in mm. | 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU | No |
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