ACL Anterior Cruciate Ligament InjuryNCT01755819
Outcome and Tunnel Widening After ACL Reconstruction: Comparison of Aperture and Cortical Fixation
A study testing Biocomposite interference screw and Extracortical ACL Tightrope fixation in people with ACL Anterior Cruciate Ligament Injury and Outcome, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- ACL Anterior Cruciate Ligament Injury, Outcome
- What is being tested?
- Biocomposite interference screw and Extracortical ACL Tightrope fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck (Traumasurgery)
Innsbruck, Tyrol, 6020
René El Attal, Dr., rene.attal@uki.at
Mariette Fasser, MSc, mariette.fasser@uki.at
About this study
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.
Read more
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.
Read the 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%.
- Conditions
- ACL Anterior Cruciate Ligament Injury, Outcome
- Being tested
- Biocomposite interference screw, Extracortical ACL Tightrope fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biocomposite interference screwDevice
Extracortical ACL Tightrope fixationDevice
| Study group | Role | What they receive |
|---|---|---|
| Biocomposite interference screw | Other | 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. Receives: Device: Biocomposite interference screw |
| Extracortical ACL Tightrope fixation | Other | 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. Receives: Device: Extracortical ACL Tightrope fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 days before (knee) operation, 6 months FU, 2 year FU
Secondary outcomes (6)
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
Measured: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Clinical outcome: influence on quality of life after knee ACL reconstruction
Clinical outcome measured by KOOS Knee related QoL subscale
Measured: 1-2 days before (knee)operation, 6 month FU, 1 year FU, 2year FU
Clinical outcome: subjective evaluation of knee function
Clinical outcome measured by Lysholm Score: subjective questionnaire
Measured: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Clinical outcome: return to sports activity
Clinical outcome measured by Tegner Activity scores: sports activity level
Measured: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Clinical outcome: strength in single leg jumping after ACL reconstruction
Single leg hop test measured in cm. Comparing the injured and healthy knee.
Measured: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Clinical outcome: objective knee anterior stability
Clinical outcome measured by KT1000 arthrometer measurements in mm.
Measured: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ACL Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. René El Attal, Medical University Innsbruck
- Investigators
- Rene El Attal, Dr., Principal investigator, Medical University Innsbruck (Traumasurgery)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755819
- Sponsor's protocol ID
- ACL Tightrope vs. Biocomposite
- Status last verified
- Jan 2013
- First submitted
- 4 Dec 2012
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eichinger M, Ploner M, Degenhart G, Rudisch A, Smekal V, Attal R, Mayr R. Tunnel widening after ACL reconstruction with different fixation techniques: aperture fixation with biodegradable interference screws versus all-inside technique with suspensory cortical buttons. 5-year data from a prospective randomized trial. Arch Orthop Trauma Surg. 2023 Nov;143(11):6707-6718. doi: 10.1007/s00402-023-05001-x. Epub 2023 Aug 5.
PubMed 37542556Mayr 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.
PubMed 31372680
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01755819
- Acronym / sponsor ID
- ACL Tightrope vs. Biocomposite
- Conditions
- ACL Anterior Cruciate Ligament Injury, Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biocomposite interference screw | Other | Device: Biocomposite interference screwThirty 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. |
| Extracortical ACL Tightrope fixation | Other | Device: Extracortical ACL Tightrope fixationThirty 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The ACL injury can be either "isolated" or combined with one or several of the following injuries visualized on MRI and/or arthroscopy:
- A radiographic examination with normal joint status or combined with either one of the following finding:
- Agreement to participate in the study and signed informed consent prior to inclusion.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biocomposite interference screw | Device | Biocomposite interference screw |
| Extracortical ACL Tightrope fixation | Device | Extracortical ACL Tightrope fixation |
Primary outcome
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.
6 secondary outcomes
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: 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: subjective evaluation of knee function
Time frame: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
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: 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
Clinical outcome: objective knee anterior stability
Time frame: 1-2 days before (knee)operation, 6 months FU, 1 year FU, 2 year FU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Derived from this study: PubMed 37542556Eichinger M, Ploner M, Degenhart G, Rudisch A, Smekal V, Attal R, Mayr R. Tunnel widening after ACL reconstruction with different fixation techniques: aperture fixation with biodegradable interference screws versus all-inside technique with suspensory cortical buttons. 5-year data from a prospective randomized trial. Arch Orthop Trauma Surg. 2023 Nov;143(11):6707-6718. doi: 10.1007/s00402-023-05001-x. Epub 2023 Aug 5.
- Derived from this study: PubMed 31372680Mayr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rene El Attal, Dr. principal investigator
Medical University Innsbruck (Traumasurgery)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biocomposite interference screw and Extracortical ACL Tightrope fixation in people with ACL Anterior Cruciate Ligament Injury and Outcome, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rene EL Attal, Dr. (0043-50-504-80875, rene.attal@uki.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01755819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.