- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03746470
A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament (ACL)
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 .
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marco Decogliano, MD
- Phone Number: +41918117029
- Email: RicercaOrtopedia.ORL@eoc.ch
Study Locations
-
-
-
Bologna, Italy
- Recruiting
- IRCCS Istituto Ortopedico Rizzoli
-
Contact:
- Davide Reale, MD
-
-
-
-
-
Lugano, Switzerland
- Recruiting
- EOC - Unità Traumatologia e Ortopedia ORL
-
Contact:
- Marco Decogliano, MD
- Email: RicercaOrtopedia.ORL@eoc.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Difficulties in compliance in following the rehabilitation programs
- Obesity (BMI ≥ 30)
- Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: insertion preserving
ACL reconstruction preserving insertion
|
Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.
|
Active Comparator: insertion detaching
ACL reconstruction detaching insertion
|
Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 months after ACL reconstruction intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months
Time Frame: 3, 12 months after ACL reconstruction intervention
|
Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla
|
3, 12 months after ACL reconstruction intervention
|
Right anatomical graft position
Time Frame: 12 months after ACL reconstruction intervention
|
Evaluation of right anatomical graft position by MRI 3 TESLA
|
12 months after ACL reconstruction intervention
|
Anterior tibial translation
Time Frame: 3, 6, 12 months after ACL reconstruction intervention
|
Anterior tibial translation will be measured in millimeters using the arthrometer Rolimeter
|
3, 6, 12 months after ACL reconstruction intervention
|
Anterior knee joint instability
Time Frame: 3, 6, 12 months after ACL reconstruction intervention
|
Anterior knee joint instability will be measured by the device KiRA (Kinematic Rapid Assessment) by the parameters of the pivot-shift test
|
3, 6, 12 months after ACL reconstruction intervention
|
IKDC (International Knee Documentation Committee) questionnaire
Time Frame: 3, 6, 12 months after ACL reconstruction intervention
|
Test to evaluate post-surgery instability with a scores range from 0 points to 100 points; patients report symptoms, sports and daily living activities
|
3, 6, 12 months after ACL reconstruction intervention
|
Tegner activity scale
Time Frame: 3, 6, 12 months after ACL reconstruction intervention
|
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.
|
3, 6, 12 months after ACL reconstruction intervention
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Marco Decogliano, MD, EOC - Unità Traumatologia e Ortopedia - ORL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ORL-ORT-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complete Tear, Knee, Anterior Cruciate Ligament
-
University of VirginiaUniversity of KentuckyUnknownComplete Tear, Knee, Anterior Cruciate Ligament | Rupture of Anterior Cruciate LigamentUnited States
-
University of Sao PauloUnknownComplete Tear, Knee, Anterior Cruciate Ligament | Rupture of Anterior Cruciate LigamentBrazil
-
Soft Tissue Regeneration, Inc.CompletedComplete Tear, Knee, Anterior Cruciate LigamentNetherlands
-
Istituto Ortopedico RizzoliCompletedComplete Tear, Knee, Anterior Cruciate LigamentItaly
-
Linkoeping UniversityUnknownComplete Tear, Knee, Anterior Cruciate LigamentSweden
-
Taipei Hospital, Ministry of Health and WelfareRecruitingAnterior Cruciate Ligament Tear | Posterior Cruciate Ligament TearTaiwan
-
eMKa MED Medical CenterWroclaw Medical UniversityRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Knee Injuries | Knee Ligament InjuryPoland
-
eMKa MED Medical CenterWroclaw Medical UniversityRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Knee Injuries | Knee Ligament InjuryPoland
-
Miach OrthopaedicsActive, not recruitingAnterior Cruciate Ligament Tear | Anterior Cruciate Ligament InjuryUnited States
-
Children's Hospital ColoradoSmith & Nephew, Inc.RecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Arthrofibrosis of KneeUnited States
Clinical Trials on ACL reconstruction preserving insertion
-
Lars KonradsenUnknown
-
Espregueira-Mendes Sports Centre - FIFA Medical...Enrolling by invitationAnterior Cruciate Ligament InjuriesPortugal
-
Larissa University HospitalUniversity of ThessalyRecruitingAnterior Cruciate Ligament InjuriesGreece
-
Second Affiliated Hospital, School of Medicine,...RecruitingAnterior Cruciate Ligament InjuriesChina
-
Schulthess KlinikRecruitingAnterior Cruciate Ligament TearSwitzerland
-
University of Sao PauloUnknownComplete Tear, Knee, Anterior Cruciate Ligament | Rupture of Anterior Cruciate LigamentBrazil
-
Tampere University HospitalCompleted
-
Peking University Third HospitalUnknownRupture of Anterior Cruciate Ligament
-
University of VirginiaUniversity of KentuckyUnknownComplete Tear, Knee, Anterior Cruciate Ligament | Rupture of Anterior Cruciate LigamentUnited States
-
University Medical Centre MariborActive, not recruitingAnterior Cruciate Ligament ReconstructionSlovenia