Complete Tear, Knee, Anterior Cruciate LigamentACLNCT03746470
A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament
A study testing ACL reconstruction preserving insertion and ACL reconstruction detaching insertion in people with Complete Tear, Knee, Anterior Cruciate Ligament, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in 2 countries.
Trial summary
This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy. The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Complete Tear, Knee, Anterior Cruciate Ligament
- What is being tested?
- ACL reconstruction preserving insertion and ACL reconstruction detaching insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Oct 2018to 29 Sep 2024
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 18 and 55
- MRI confirmed primary and total ACL injury of traumatic origin
- Indication for ACL reconstruction in arthroscopy
- Written informed consent
- Active and non-sedentary lifestyle
Who cannot join
- Complex meniscal injuries
- Cartilage lesions of sizes> 2 cm2
- Other ligamentous lesions
- Axis deviations greater than 10°
- Rheumatic, neuromuscular or general systemic diseases
- Prevention of injured knee traumas treated surgically
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- Difficulties in compliance in following the rehabilitation programs
- Obesity (BMI ≥ 30)
- Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized Controlled Trial to Evaluate the Graft Ligamentization and Integration in the Reconstruction of the Anterior Cruciate Ligament With or Without Detachment of Hamstring Tendon Tibial Insertion
This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy.
The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .
- Being tested
- ACL reconstruction preserving insertion, ACL reconstruction detaching insertion
- Keywords
- arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction preserving insertionProcedure or surgery
Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.
ACL reconstruction detaching insertionProcedure or surgery
Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.
| Study group | Role | What they receive |
|---|---|---|
| insertion preserving | Experimental | ACL reconstruction preserving insertion Receives: Procedure: ACL reconstruction preserving insertion |
| insertion detaching | Active comparator | ACL reconstruction detaching insertion Receives: Procedure: ACL reconstruction detaching insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft integration by the Signal / Noise Quotient (SNQ) at 6 months
Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla
Measured: 6 months after ACL reconstruction intervention
Secondary outcomes (6)
Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months
Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla
Measured: 3, 12 months after ACL reconstruction intervention
Right anatomical graft position
Evaluation of right anatomical graft position by MRI 3 TESLA
Measured: 12 months after ACL reconstruction intervention
Anterior tibial translation
Anterior tibial translation will be measured in millimeters using the arthrometer Rolimeter
Measured: 3, 6, 12 months after ACL reconstruction intervention
Anterior knee joint instability
Anterior knee joint instability will be measured by the device KiRA (Kinematic Rapid Assessment) by the parameters of the pivot-shift test
Measured: 3, 6, 12 months after ACL reconstruction intervention
IKDC (International Knee Documentation Committee) questionnaire
Test to evaluate post-surgery instability with a scores range from 0 points to 100 points; patients report symptoms, sports and daily living activities
Measured: 3, 6, 12 months after ACL reconstruction intervention
Tegner activity scale
Test to evaluate post-surgery instability with a scores range from 0 points to 10 points; patients describe their current level of activity and that before injury.
Measured: 3, 6, 12 months after ACL reconstruction intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start22 Oct 2018
- Primary completion29 Sep 2024
- Study completion29 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete Tear, Knee, Anterior Cruciate LigamentStudies of the same condition, open and under way.
- 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Responsible party
- Sponsor
- Investigators
- Marco Decogliano, MD, Study chair, EOC - Unità Traumatologia e Ortopedia - ORL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746470
- Sponsor's protocol ID
- ORL-ORT-003
- Acronym
- ACL
- Status last verified
- Aug 2025
- First submitted
- 30 Oct 2018
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Graft Ligamentization and Integration in the Reconstruction of the Anterior Cruciate Ligament With or Without Detachment of Hamstring Tendon Tibial Insertion
- ClinicalTrials.gov ID
- NCT03746470
- Acronym / sponsor ID
- ACL / ORL-ORT-003
- Keywords
- arthroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Collaborators
- Clinical Trial Unit Ente Ospedaliero Cantonale
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 29 Sep 2024 (actual)
- Study completion
- 29 Sep 2024 (actual)
- First posted
- 19 Nov 2018 (actual)
- 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.
This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy.
The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insertion preserving | Experimental | Procedure: ACL reconstruction preserving insertionACL reconstruction preserving insertion |
| insertion detaching | Active comparator | Procedure: ACL reconstruction detaching insertionACL reconstruction detaching insertion |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age between 18 and 55
- MRI confirmed primary and total ACL injury of traumatic origin
- Indication for ACL reconstruction in arthroscopy
- Written informed consent
- Active and non-sedentary lifestyle
Key exclusion criteria (9 listed)
- Complex meniscal injuries
- Cartilage lesions of sizes> 2 cm2
- Other ligamentous lesions
- Axis deviations greater than 10°
- Rheumatic, neuromuscular or general systemic diseases
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 |
|---|---|---|
| ACL reconstruction preserving insertionAnterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring. | Procedure or surgery | insertion preserving |
| ACL reconstruction detaching insertionAnterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring. | Procedure or surgery | insertion detaching |
Primary outcome
Graft integration by the Signal / Noise Quotient (SNQ) at 6 months
Time frame: 6 months after ACL reconstruction intervention
Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla
6 secondary outcomes
Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months
Time frame: 3, 12 months after ACL reconstruction intervention
Right anatomical graft position
Time frame: 12 months after ACL reconstruction intervention
Anterior tibial translation
Time frame: 3, 6, 12 months after ACL reconstruction intervention
Anterior knee joint instability
Time frame: 3, 6, 12 months after ACL reconstruction intervention
IKDC (International Knee Documentation Committee) questionnaire
Time frame: 3, 6, 12 months after ACL reconstruction intervention
Tegner activity scale
Time frame: 3, 6, 12 months after ACL reconstruction intervention
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 6 Aug 2025.
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.
Marco Decogliano, MD study chair
EOC - Unità Traumatologia e Ortopedia - ORL
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction preserving insertion and ACL reconstruction detaching insertion in people with Complete Tear, Knee, Anterior Cruciate Ligament, run by Ente Ospedaliero Cantonale, Bellinzona at 2 sites in 2 countries.
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 5 inclusion and 9 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. 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?
Graft integration by the Signal / Noise Quotient (SNQ) at 6 months (time frame: 6 months after ACL reconstruction intervention). 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 6 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.