Knee
Conditions
Interventions
This is a prospective, two-arm, randomized controlled clinical trial conducted at a single center, with an independent outcome assessor blinded to group allocation. A total of 60 participants were enr
Sponsors
Hospital do Trabalhador
Hospital do Trabalhador
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older. Both sexes. Tibial shaft fractures classified as AO/OTA 42. Indication for treatment with locked intramedullary nailing. Ability to comply with follow-up. Signed informed consent form
Exclusion criteria
Exclusion criteria: Open fractures classified as Gustilo-Anderson type IIIB or IIIC. Prior surgery on the affected knee or tibia. Previous or concurrent fasciotomy. Significant associated injuries except ipsilateral fibula fracture. Preexisting degenerative joint disease. Inability to comply with follow-up. Loss to follow-up before 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find improved functional recovery at 48 weeks after surgery, verified through the Kujala patellofemoral score, using the comparison of values obtained at 2, 12, 24 and 48 week follow-up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe progressive improvement in lower limb function, verified through the American Orthopaedic Foot and Ankle Society score (AOFAS), using the comparison of values obtained preoperatively and at 12, 24 and 48 week follow-up visits;It is expected to observe a reduction in fluoroscopy time during the surgical procedure, verified through the time recorded in seconds by the intraoperative fluoroscopy device | — |
Countries
Brazil
Contacts
Public ContactLuis Longo
Hospital do Trabalhador
Outcome results
None listed