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Outcome and Tunnel Widening After ACL Reconstruction: Comparison of Aperture and Cortical Fixation

Primary Purpose

ACL Anterior Cruciate Ligament Injury, Outcome

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Biocomposite interference screw
Extracortical ACL Tightrope fixation
Sponsored by
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Anterior Cruciate Ligament Injury

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University Innsbruck (Traumasurgery)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Biocomposite interference screw

Extracortical ACL Tightrope fixation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Clinical outcome: influence on quality of life after knee ACL reconstruction
Clinical outcome measured by KOOS Knee related QoL subscale
Clinical outcome: subjective evaluation of knee function
Clinical outcome measured by Lysholm Score: subjective questionnaire
Clinical outcome: return to sports activity
Clinical outcome measured by Tegner Activity scores: sports activity level
Clinical outcome: strength in single leg jumping after ACL reconstruction
Single leg hop test measured in cm. Comparing the injured and healthy knee.
Clinical outcome: objective knee anterior stability
Clinical outcome measured by KT1000 arthrometer measurements in mm.

Full Information

First Posted
December 4, 2012
Last Updated
January 15, 2013
Sponsor
Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT01755819
Brief Title
Outcome and Tunnel Widening After ACL Reconstruction: Comparison of Aperture and Cortical Fixation
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 Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The study is a randomized controlled clinical trial and will be conducted at the Traumasurgery Innsbruck. Two different surgical methods are tested: ACL Tightrope reconstruction VS Biocomposite interference screws. Following eligibility criteria have to be met: Age 18 -40 years ACL insufficiency diagnosed by clinical examination (positive Lachman test and/or pivot shift test) and MRI (complete tear) Not more than 12 month after trauma to the knee Tegner Score 5 to 10 Not eligible if: Earlier major knee injury to the index knee Previous knee surgery (except diagnostic arthroscopy) to index knee Associated knee fractures Associated PCL injury, complete MCL or LCL tear Concomitant severe injury to contra-lateral knee at time of assessment Injury to the lateral/posterolateral ligament complex with increased laxity (positive dial test and external rotation thigh foot angle test), Pregnancy and scope to become within next time A history of deep vein thrombosis (DVT) or a disorder of the coagulative system Claustrophobia General systemic disease affecting physical function, any other condition or treatment interfering with the completion of the trial, including patients with metal devices, pacemaker or motion disorders Chronic systemic use of steroids Following inclusion and exclusion criteria have to be met: Inclusion: 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 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) Agreement to participate in the study and signed informed consent prior to inclusion. Exclusion: 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 A power analysis was performed, estimating that a minimum of 34 patients (17 in each group) would be required to obtain a power more than 80%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Anterior Cruciate Ligament Injury, Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biocomposite interference screw
Arm Type
Other
Arm Description
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.
Arm Title
Extracortical ACL Tightrope fixation
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Biocomposite interference screw
Intervention Type
Device
Intervention Name(s)
Extracortical ACL Tightrope fixation
Primary Outcome Measure Information:
Title
Change of tunnel volume and diameter from baseline up to 2 year follow up
Description
CT tunnel measurements are conducted. Tunnel volume are calculated by CT volumetry measured in mm³ and tunnel diameter is measured in mm.
Time Frame
1-2 days before (knee) operation, 6 months FU, 2 year FU
Secondary Outcome Measure Information:
Title
Clinical outcome: international knee score evaluating objective and subjective knee outcome variables
Description
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
Time Frame
1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Title
Clinical outcome: influence on quality of life after knee ACL reconstruction
Description
Clinical outcome measured by KOOS Knee related QoL subscale
Time Frame
1-2 days before (knee)operation, 6 month FU, 1 year FU, 2year FU
Title
Clinical outcome: subjective evaluation of knee function
Description
Clinical outcome measured by Lysholm Score: subjective questionnaire
Time Frame
1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Title
Clinical outcome: return to sports activity
Description
Clinical outcome measured by Tegner Activity scores: sports activity level
Time Frame
1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Title
Clinical outcome: strength in single leg jumping after ACL reconstruction
Description
Single leg hop test measured in cm. Comparing the injured and healthy knee.
Time Frame
1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Title
Clinical outcome: objective knee anterior stability
Description
Clinical outcome measured by KT1000 arthrometer measurements in mm.
Time Frame
1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rene EL Attal, Dr.
Phone
0043-50-504-80875
Email
rene.attal@uki.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rene El Attal, Dr.
Organizational Affiliation
Medical University Innsbruck (Traumasurgery)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck (Traumasurgery)
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René El Attal, Dr.
Email
rene.attal@uki.at
First Name & Middle Initial & Last Name & Degree
Mariette Fasser, MSc
Email
mariette.fasser@uki.at
First Name & Middle Initial & Last Name & Degree
Raul Mayr, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
31372680
Citation
Mayr R, Smekal V, Koidl C, Coppola C, Eichinger M, Rudisch A, Kranewitter C, Attal R. ACL reconstruction with adjustable-length loop cortical button fixation results in less tibial tunnel widening compared with interference screw fixation. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1036-1044. doi: 10.1007/s00167-019-05642-9. Epub 2019 Aug 1.
Results Reference
derived

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Outcome and Tunnel Widening After ACL Reconstruction: Comparison of Aperture and Cortical Fixation

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