Dislocation, sprain, and strain of the knee joints and ligaments
Conditions
Interventions
This is a prospective randomized controlled single-center two-arm clinical trial involving 80 participants aged between 18 and 50 years with complete anterior cruciate ligament rupture and repairable
however, the evaluator responsible for neurological and functional outcomes will be independent and will not participate in the surgical procedures. In the intervention group, consisting of 40 partici
Sponsors
INTO - Instituto Nacional de Traumatologia e Ortopedia
INTO - Instituto Nacional de Traumatologia e Ortopedia
Eligibility
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; age between 18 and 50 years; confirmed diagnosis of complete anterior cruciate ligament rupture with surgical indication for reconstruction; presence of a repairable medial meniscus lesion identified by magnetic resonance imaging and confirmed by arthroscopy; peripheral longitudinal medial meniscus tears or reducible ramp lesions amenable to inside-out repair technique; candidates for anterior cruciate ligament reconstruction using autologous semitendinosus and gracilis tendon grafts; ability to understand and sign the Informed Consent Form; availability for postoperative follow-up during the study period
Exclusion criteria
Exclusion criteria: Previous surgery on the affected knee; multiligament knee injuries requiring additional surgical approaches; complex meniscal lesions not amenable to repair using the inside-out technique; medial meniscus root tears requiring transtibial root repair; preexisting peripheral neuropathies or neurological diseases impairing sensory evaluation; flexion contracture or joint limitation preventing adequate postoperative assessment; use of an anterior cruciate ligament reconstruction technique other than autologous semitendinosus and gracilis tendon grafts; inability to attend follow-up visits scheduled in the protocol; refusal to sign the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the incidence of saphenous nerve neuropraxia is expected in patients undergoing medial meniscus repair using the inside-out technique without posteromedial incision compared with the conventional technique with posteromedial incision. Neuropraxia will be assessed through standardized sensory physical examination using light tactile and painful stimuli, identification of hypoesthetic areas greater than or equal to 1 square centimeter, visual analog scale for neurosensory symptoms, and neuropathic pain questionnaire. Data will be collected on postoperative days 1, 3, 7, 14, and 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in the area of hypoesthesia related to the saphenous nerve is expected, assessed through standardized patient drawings and quantification of the affected area in square centimeters;Lower intensity of neuropathic symptoms is expected, assessed using a visual analog scale and neuropathic pain questionnaire during the same postoperative periods;A reduction in total surgical time and in the time required to perform meniscal repair is expected, measured in minutes during the surgical procedure;Similar rates of meniscal repair failure are expected between groups, defined as the need for repeat surgical intervention on the repaired medial meniscus during 1-year and 2-year follow-up. ;Similar functional evolution between groups is expected, assessed through knee range of motion, presence of joint effusion, and functional knee scores during postoperative follow-up of up to 2 years | — |
Countries
BR
Contacts
Public ContactYuri Sampaio
INTO - Instituto Nacional de Traumatologia e Ortopedia
Outcome results
None listed