NCT02750072

INfrapatellar Versus SUprapatellar Reamed Intramedullary Nailing for Fractures of the Tibia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Fraser Orthopaedic Research Society · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the incidence and severity of anterior knee pain comparing two different approaches to tibial nail fixation; Infrapatellar versus percutaneous semi-extended suprapatellar incisions. Half the patients will be randomized to the gold standard infrapatellar approach with the other half being randomized to treatment with the percutaneous semi-extended suprapatellar approach.

Detailed description

There are a number of ways to approach the tibial canal when using an intramedullary nail for fracture fixation. The gold standard is the infrapatellar approach (below the knee cap). This approach has the patient positioned with the knee flexed at 90 degrees or greater on the operating table. However, there are challenges with this approach, including imaging, placement of supplemental fixation, conversion to open reduction when necessary and malunion with apex anterior angulation for proximal tibial fractures. The positioning of the patient causes tension on the structures and soft tissues around the knee which can hinder the placement of the nail and can cause damage to the soft tissues that can result in significant long-term anterior knee pain for many patients. The semi-extended suprapatellar approach has the patient positioned in approximately 15-20 degrees of flexion, putting less tension on the structures and soft tissues about the knee and enables the surgeon to insert the nail in an optimal position with relative ease.

Conditions

• Tibial Fractures
• Anterior Knee Pain Syndrome

Interventions

Type	Name	Description
PROCEDURE	Infrapatellar Approach	Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
PROCEDURE	Suprapatellar Approach	Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation

Timeline

• Start date: 2016-09-13
• Primary completion: 2023-05-31
• Completion: 2023-10-12
• First posted: 2016-04-25
• Last updated: 2024-01-30

Locations

6 sites across 2 countries: Canada, Spain