Anterior Cruciate Ligament Injuries
Conditions
Interventions
This is a two-arm, open-label, randomized controlled clinical trial with 84 participants divided into two parallel groups in a 1:1 ratio. Randomization was performed using permuted blocks, stratified
Sponsors
Hospital Maradei
Hospital Maradei
Instituto de Ciências da Saúde da Universidade Federal do Pará - UFPA
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Both sexes; age between 18 and 50 years; isolated anterior cruciate ligament injury confirmed by magnetic resonance imaging; indication for primary surgical reconstruction of the anterior cruciate ligament; residence in Belém do Pará; signed informed consent form
Exclusion criteria
Exclusion criteria: Previous history of knee surgeries; associated meniscal or chondral lesions grade III or IV; neuromuscular or rheumatological diseases; smoking; refusal to sign the informed consent form; identification of associated meniscal or cartilage lesions grade III or IV during intraoperative assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A difference in knee function between the two groups is expected, assessed using the subjective International Knee Documentation Committee score, a self-administered questionnaire validated for Brazilian Portuguese that generates a score from 0 to 100 where higher values indicate better function and fewer symptoms, applied preoperatively and at 6, 12 and 24 months postoperatively, this being the outcome used to calculate the sample size with a minimal clinically important difference of 10 points, statistical power of 80% and confidence of 90%;A difference in knee function between the two groups is expected, assessed using the Lysholm Knee Scoring Scale, a self-administered questionnaire validated for Portuguese composed of eight questions that generates a score from 0 to 100, applied preoperatively and at 6, 12 and 24 months postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| A difference in pain level at the graft donor site between the two groups is expected, assessed using a visual analog scale from 0 to 10 where 0 represents no pain and 10 represents the worst imaginable pain, measured exclusively at the 1-month postoperative visit, with the donor site being the anterior aspect of the thigh for the rectus femoris group and the posterior aspect of the thigh for the hamstring group;A difference in range of motion recovery of the operated knee between the two groups is expected, assessed by measuring passive flexion and extension using a universal goniometer, with values recorded in degrees at the 1, 6, 12 and 24 months postoperative assessments;The incidence of adverse events between the two groups is expected to be assessed, including surgical site infection, deep vein thrombosis, joint stiffness (arthrofibrosis) and neurovascular injury, actively monitored and recorded on a standard form at all follow-up visits during the first 12 months postoperatively | — |
Countries
BR
Contacts
Public ContactGeorge Lima
Hospital Maradei
Outcome results
None listed