Anterior Cruciate Ligament injuries
Conditions
Interventions
This is a randomized, controlled, double-blind, two-arm clinical trial. A total of 88 participants will be allocated to the groups using a block randomization system. Experimental group: 44 individual
Sponsors
Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
16 Years to 50 Years
Inclusion criteria
Inclusion criteria: Patients with unilateral anterior cruciate ligament injury with surgical indication, with or without associated meniscal lesions; Patients with skeletal maturity; Both genders; Aged between 16 and 50 years
Exclusion criteria
Exclusion criteria: Presence of other associated ligament injuries requiring reconstruction; Patients with mechanical axis deviation of the lower limb requiring corrective osteotomy; Presence of chondral lesions requiring repair; Presence of associated fractures or other pathological conditions of the lower limbs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to observe a mean difference of at least 1 mm between the groups (with and without the use of the Biobrace® bioinductive implant) in the differences of anterior tibial translation between operated and non-operated sides, as assessed by the KT-1000 arthrometer test after a 2-year postoperative follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe similar or better functional outcomes in anterior cruciate ligament reconstruction with the bioinductive Biobrace® implant compared to reconstruction without the implant, as assessed by the International Knee Documentation Committee (IKDC) and Lysholm Knee Scoring Scale at 6 months, 1 year, and 2 years of postoperative follow-up;It is expected to observe lower failure rates of anterior cruciate ligament reconstruction with the bioinductive Biobrace® implant compared to anterior cruciate ligament reconstruction without the implant, after 6 months, 1 year, and 2 years of postoperative follow-up;It’s expected to find lower or similar residual rotational knee instability, as assessed by the pivot shift clinical test, in anterior cruciate ligament reconstruction with the bioinductive Biobrace® implant compared to reconstruction without the implant, after 6 months, 1 year, and 2 years of postoperative follow-up;It is expected to find a shorter or similar graft maturation time in anterior cruciate ligament reconstructions with the bioinductive Biobrace® implant compared to reconstructions without the implant, as assessed by the graft signal-to-noise quotient (SNQ) on postoperative magnetic resonance imaging at 6 months, 1 year, and 2 years | — |
Countries
Brazil
Contacts
Public ContactCamilo Helito
Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed