Comparing two methods of ACL reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of combined intra- and extra-articular ACL reconstruction with anterolateral ligament (ALL) reinforcement against isolated intra-articular ACL reconstruction using hamstring autografts. A total of 146 patients aged 14 to 25 will be randomly assigned to one of the two surgical approaches. Participants will be evaluated preoperatively and at multiple intervals post-surgery to assess clinical outcomes and failure rates. The study seeks to determine if the addition of ALL reconstruction can reduce re-injury rates compared to traditional methods.

Why it matters

Who can join: the full rules

Inclusion 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-Inclusion Criteria

* 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 tibia in the clinical examination) or \> 10 degrees axis deviation to valgus (corresponding to \> 16 degrees valgus between the anatomical axis of the femur and the anatomical axis of the tibia in the clinical examination);
* Graft diameter \< 7 mm;
* BMI \> 35 or \< 18;
* Active or undergoing treatment for malignant neoplasia;
* Pregnancy or suspected pregnancy;
* Psychiatric disorders.

Exclusion Criteria

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 in order to receive financial assistance with work leave.

Where it's running

• Sao Paulo Hospital
  São Paulo, São Paulo, Brazil Recruiting
• Parelheiros Hospital
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Marcos Vinicius Credidio — Federal University of São Paulo
• Study coordinator: Marcos Vinicius Credidio
• Email: mvcredidio@gmail.com
• Phone: 11980629367

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Optimized rehabilitation program for ACL recovery before returning to sports

  This study tests if a personalized rehab program with regular check-ins can help people recover better from ACL surgery and safely get back to sports.

  Recruiting at 3 sites Centre Hospitalier Universitaire de Saint Etienne · Challes-les-Eaux and 7 other locations · NCT05323474

• Quadriceps tendon vs peroneus longus tendon grafts for ACL reconstruction

  This randomized trial tests whether using a quadriceps tendon autograft works as well as a peroneus longus tendon autograft for ACL reconstruction in adults, looking at knee function and donor-site effects.

  Recruiting Acibadem University · Istanbul, Besiktas · NCT07671729

• Proprioceptive exercises to aid recovery after ACL surgery

  This trial will see if adding proprioceptive exercises to standard balance training helps people aged 20–40 during the early rehab period after ACL surgery.

  Recruiting Uskudar University · Sanliurfa · NCT07333092

• All-inside versus complete tibial tunnel ACL reconstruction using hamstring grafts

  This trial will test whether the all-inside or the complete tibial tunnel surgical technique leads to better recovery in adults (18–65) having ACL reconstruction with hamstring grafts.

  Recruiting at 2 sites Universitas Indonesia · Depok and 1 other locations · NCT07023653

• Cross bracing versus early ACL reconstruction for recent ACL rupture

  This will try whether a 12-week cross bracing program plus supervised physiotherapy helps people aged 16–40 with a recent complete ACL tear more than early ACL reconstruction surgery.

  Recruiting University of Melbourne · Melbourne, Victoria · NCT06956339

• Hockey slideboard training with blood flow restriction for ACL rehabilitation

  This study is testing if combining hockey slideboard training with blood flow restriction can help people recover better and safer after ACL surgery.

  Recruiting Spitalul Municipal Odorheiu Secuiesc · Odorheiu Secuiesc, Romania · NCT06955026

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.