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Compares treatment options for Anterior Cruciate Ligament Rupture
Official title Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
ClinicalTrials.gov ID: NCT06505525
What this study is testing
- What it's testing
- Abstract Introduction: Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide. There are several ways to prepare the graft using these tendons.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 40
You may be able to join if
- Patients from the hospital's demand (emergency care and outpatient care) and from CROSS (Center for Regulation of Health Service Offers) who present...
- Age (Female 14 years - 25 years and Male 16 years - 25 years);
- Pivot-shift test \> 2;
- Chronic ACL injury (\>12 months);
- Athlete (Tegner Scale ≥ 7);
You likely can't join if
- Leave of absence from work due to disability or reduced income assistance (worker's compensation) whenever one of the investigators considers that...
See the full eligibility criteria
- Patients from the hospital's demand (emergency care and outpatient care) and from CROSS (Center for Regulation of Health Service Offers) who present one or more risk factors will be included:
- Age (Female 14 years - 25 years and Male 16 years - 25 years);
- Pivot-shift test \> 2;
- Chronic ACL injury (\>12 months);
- Athlete (Tegner Scale ≥ 7);
- Tibial slope \> 12 degrees;
- Recurvatum \> 5 degrees and \< 15 degrees (asymmetric);
- Ligamentous Hypermobility (Beighton Scale \> 5). Non- Individuals over 40 years of age will not be included;
- ACL revision;
- PCL injury (grade 2 and 3);
- MCL injury (grade 2 and 3) or (grade 1 with valgus aligned axis);
- CPL injury (grade 2 and 3 according to Fanelli classification);
- Recurrent patellar dislocation;
- Severe chondral lesion (ICRS grade 3 and 4) larger than 1cm2;
- Previous ipsilateral knee surgery;
- Kellgren Lawrence grade 3 or more;
- Autoimmune/rheumatologic inflammatory disease;
- Contralateral knee ligament injury;
- Malalignment \> 5 degrees clinical asymmetry between limbs or symmetric \> 10 degrees axis deviation to varus (corresponding to \> 4 degrees varus between the anatomical axis of the femur and the anatomical axis of the...
- Graft diameter \< 7 mm;
- BMI \> 35 or \< 18;
- Active or undergoing treatment for malignant neoplasia;
- Pregnancy or suspected pregnancy;
- Psychiatric disorders.
- Leave of absence from work due to disability or reduced income assistance (worker's compensation) whenever one of the investigators considers that the participant may be simulating a worse health condition than reality...
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.