Anterior Cruciate Ligament RuptureNCT02000258
Effect of Tunnel Placements on Clinical and MRI Findings Two Years After ACL Reconstruction With DB Technique
A study testing Double-bundle ACL reconstruction and Magnetic resonance imaging (MRI) in people with Anterior Cruciate Ligament Rupture, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Double-bundle ACL reconstruction and Magnetic resonance imaging (MRI)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2003to Aug 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- primary ACL reconstruction, closed growth plates
Who cannot join
- ligament injury to the opposite knee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique
Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee.
Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Double-bundle ACL reconstruction, Magnetic resonance imaging (MRI)
- Keywords
- Anterior cruciate ligament reconstruction, Double-bundle, MRI, Graft location
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-bundle ACL reconstructionProcedure or surgery
Magnetic resonance imaging (MRI)Device
Also called MRI evaluations were made with a 1.5-T Signa Excite HD imager (GE Healthcare, Milwaukee, WI) by use of an eight-channel receiver/transmitter extremity coil., The interpretation of the images was made with the Impax DS 3000 workstation (Agfa HealthCare, Mortsel, Belgium)
MRI sequences were as follows: sagittal T1-weighted, proton density (PD)-weighted and T2-weighted fast spin echo (FSE) images with 4 mm slice and 1 mm gap, coronal T1-weighted and fat-saturated T2-weighted FSE images with 4 mm slice and 1 mm gap, axial fat saturated PD FSE images with 4 mm slice and 1 mm gap and oblique sagittal and oblique coronal T1 FSE images along AM graft plane with 3 mm slice and 0.3 mm gap.
| Study group | Role | What they receive |
|---|---|---|
| Double-bundle ACL reconstruction | Other | Double-bundle ACL reconstruction Receives: Procedure: Double-bundle ACL reconstruction |
| Magnetic resonance imaging (MRI) | Other | MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery. Receives: Device: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages
The measurements of the graft location from the MRI were made by two musculoskeletal radiologists separately and the means of these measurements were used. In brief, first the centers of the tunnels were measured from sagittal images referring to the Blumensaat's line and to the posterior femoral condyle. Then these were divided with the maximum diameters of the femoral condyle parallel to and perpendicular to the Blumensaat's line. In the tibial side, the centers of the tunnels were measured from the anterior edge of the tibial plateau and then divided with the maximum diameter of the plateau, which was measured from the sagittal view.
Measured: 2 years after surgery
The visibility of the ACL grafts measured from the MRI
Two musculoskeletal radiologists made the interpretation of the images separately and the means of these measurements were used. A graft was considered visible when intact graft fibers were seen. The graft was considered partially visible when only few graft fibers were seen. The graft was considered invisible when no graft fibers were seen.
Measured: 2 years after surgery
Secondary outcomes (4)
KT-1000 measurement (mm) of the knees of 61 patients
KT-1000 measurements were reported as millimeters.
Measured: 2 years after surgery
International Knee Documentation Committee (IKDC) functional score
IKDC functional score was used to evaluate knee functions (IKDC scale: 0-10). Full function without any limitations was scored as 10, while zero indicated that those patients were unable to perform their daily activities.
Measured: 2 years after surgery
Lysholm knee evaluation score
Patients completed the Lysholm knee score, which measures subjective functions e.g. squatting and running. The scale is 0-100, 100 being perfect functioning of the knee.
Measured: 2 years after surgery
Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form
The clinical evaluation was performed on the basis of IKDC knee examination form, which gives the final score A-D. A being normal, B nearly normal, C abnormal and D severely abnormal.
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startMar 2003
- Primary completionSep 2010
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timo Järvelä, MD, PhD, Study chair, Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000258
- Sponsor's protocol ID
- R02071
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tunnel Placements on Clinical and MRI Findings Two Years After Anterior Cruciate Ligament Reconstruction With Double-Bundle Technique
- ClinicalTrials.gov ID
- NCT02000258
- Acronym / sponsor ID
- R02071
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior cruciate ligament reconstruction, Double-bundle, MRI, Graft location
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Sep 2010 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Dec 2013 (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.
Purpose: To find out whether the clinical and MRI findings two years after anterior cruciate ligament (ACL) reconstruction were associated with each other so that MRI-based graft invisibility in the anteromedial (AM) graft would have an impact on anteroposterior stability of the knee, and MRI-based posterolateral (PL) graft invisibility on rotational stability of the knee.
Methods: 75 patients. One experienced orthopaedic surgeon performed all double-bundle (DB) ACL reconstructions. Two independent examiners made the clinical examinations at the two-year follow-up: clinical examination of the knee, KT-1000, International Knee Documentation Committee (IKDC) and Lysholm knee evaluation scores and IKDC functional score. The MRI evaluations were made by two musculoskeletal radiologists separately and the means of these measurements were used.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-bundle ACL reconstruction | Other | Procedure: Double-bundle ACL reconstructionDouble-bundle ACL reconstruction |
| Magnetic resonance imaging (MRI) | Other | Device: Magnetic resonance imaging (MRI)MRI of the ACL double-bundle reconstructed knee was done at 2 years after surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- primary ACL reconstruction, closed growth plates
Key exclusion criteria (1 listed)
- ligament injury to the opposite knee
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 |
|---|---|---|
| Double-bundle ACL reconstruction | Procedure or surgery | Double-bundle ACL reconstruction |
| Magnetic resonance imaging (MRI)Also: MRI evaluations were made with a 1.5-T Signa Excite HD imager (GE Healthcare, Milwaukee, WI) by use of an eight-channel receiver/transmitter extremity coil., The interpretation of the images was made with the Impax DS 3000 workstation (Agfa HealthCare, Mortsel, Belgium)MRI sequences were as follows: sagittal T1-weighted, proton density (PD)-weighted and T2-weighted fast spin echo (FSE) images with 4 mm slice and 1 mm gap, coronal T1-weighted and fat-saturated T2-weighted FSE images with 4 mm slice and 1 mm gap, axial fat saturated PD FSE images with 4 mm slice and 1 mm gap and oblique sagittal and oblique coronal T1 FSE images along AM graft plane with 3 mm slice and 0.3 mm gap. | Device | Magnetic resonance imaging (MRI) |
Primary outcome
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages
Time frame: 2 years after surgery
The measurements of the graft location from the MRI were made by two musculoskeletal radiologists separately and the means of these measurements were used. In brief, first the centers of the tunnels were measured from sagittal images referring to the Blumensaat's line and to the posterior femoral condyle. Then these were divided with the maximum diameters of the femoral condyle parallel to and perpendicular to the Blumensaat's line. In the tibial side, the centers of the tunnels were measured from the anterior edge of the tibial plateau and then divided with the maximum diameter of the plateau, which was measured from the sagittal view.
The visibility of the ACL grafts measured from the MRI
Time frame: 2 years after surgery
Two musculoskeletal radiologists made the interpretation of the images separately and the means of these measurements were used. A graft was considered visible when intact graft fibers were seen. The graft was considered partially visible when only few graft fibers were seen. The graft was considered invisible when no graft fibers were seen.
4 secondary outcomes
KT-1000 measurement (mm) of the knees of 61 patients
Time frame: 2 years after surgery
International Knee Documentation Committee (IKDC) functional score
Time frame: 2 years after surgery
Lysholm knee evaluation score
Time frame: 2 years after surgery
Clinical evaluation of the knees on the basis of International Knee Documentation Committee (IKDC) examination form
Time frame: 2 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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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.
Timo Järvelä, MD, PhD study chair
Arthroscopic and sports medicine center Omasairaala, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double-bundle ACL reconstruction and Magnetic resonance imaging (MRI) in people with Anterior Cruciate Ligament Rupture, run by Tampere University Hospital at 1 site in Finland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The location of the ACL grafts in the insertion site in the femur and in the tibia reported as percentages (time frame: 2 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2013.