Comparing two knee reconstruction techniques and rehab after ACL tear
Analysis Of Knee Joint Stability, Functional Capacity, Postural Control, Activation And Muscle Strength Of Patients With Anterior Cruciate Ligament Injury Undergoing Physiotherapy After Two Different Surgical Techniques: A Randomized Clinical Trial.
NA · Universidade Estadual de Londrina · NCT06809920
This trial will test whether adding an anterolateral ligament (ALL) reconstruction to standard ACL surgery helps people aged 18–50 with a torn ACL recover better during nine months of physiotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Universidade Estadual de Londrina (other) |
| Locations | 3 sites (Londrina, Paraná and 2 other locations) |
| Trial ID | NCT06809920 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial will enroll 20 adults with unilateral ACL tears treated at the Knee Outpatient Clinic of Hospital das Clínicas da UEL in Londrina, Brazil. Participants are randomly assigned to ACL reconstruction using quadruple flexor tendons alone or ACL reconstruction plus ALL reconstruction, and all receive conventional physiotherapy rehabilitation for up to nine months. Outcomes include knee joint stability, functional capacity, postural control, muscle activation, and muscle strength measured over the rehabilitation period. The study focuses on short- to mid-term functional and biomechanical differences between the two surgical approaches when combined with standard physiotherapy.
Who should consider this trial
Good fit: Ideal candidates are men or women aged 18–50 with a unilateral ACL tear who live in Londrina, are cleared for ACL surgery, and have no major comorbidities that preclude surgery or rehabilitation.
Not a fit: Patients with BMI over 35, multidirectional laxity, multiligament injuries, prior ACL reconstruction, significant osteoarthritis, need for meniscal repair, neurological or heart disease, pregnancy, or prior lower-limb surgeries are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined ACL+ALL approach could improve knee stability and functional recovery compared with ACL reconstruction alone.
How similar studies have performed: Previous studies of adding ALL reconstruction to ACL repair have shown some improvements in rotational stability and reduced graft failure in select groups, but results across studies are mixed and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - participants with 18 to 50 years old; - both sexes; - sedentary; -active; - athletes; - diagnosed unilateral ACL injury; - patients residing in the city of Londrina - PR. Exclusion Criteria: - BMI (Body Mass Index) above 35 kg/m2; - multidirectional ligament laxity; - associated multiligament injury (PCL and posterolateral corner); - previous or current lower limb fractures; - previous ACL reconstruction (revision); - signs of osteoarthritis; - indication for meniscus suture; - neurological disease; - pregnant women; - heart disease; - previous lower limb surgeries.
Where this trial is running
Londrina, Paraná and 2 other locations
- university hospital of the State University of Londrina — Londrina, Paraná, Brazil (RECRUITING)
- University Hospital of the State University of Londrina — Londrina, Paraná, Brazil (RECRUITING)
- State University of Londrina — Londrina, Paraná, Brazil (RECRUITING)
Study contacts
- Study coordinator: Christiane Macedo
- Email: chmacedo@uel.br
- Phone: +55 43 991015123
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Reconstruction Rehabilitation, Knee, Knee Injuries, Anterior Cruciate Ligament Reconstruction, Physiotherapy