Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study (SP-Pilot)

Florida Orthopaedic Institute

Status: Completed

Conditions: Tibial Fractures

Treatments: Procedure: Infrapatellar approach; Procedure: Suprapatellar approach

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01341418

OTA 39 (Other Grant/Funding Number)

SP-2676-3103

Details and patient eligibility

About

This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.

Full description

Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming
• Acute tibial fractures within 4 weeks of injury
• Closed or open tibial fractures after appropriate irrigation and debridement
• Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia
• Skeletally mature patient
• Age 18 and above.

Exclusion criteria

• Tibial shaft fractures that require articular reconstruction with plates
• Any tibial fracture extending > 1 cm into the proximal or distal 1/5 of tibia
• Tibial plateau fractures
• Pilon fractures
• Periprosthetic fractures
• Non-unions
• Prior knee surgery
• History of gout or rheumatoid or osteoarthritis
• Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)
• Spinal injury
• Prisoner or high likelihood of incarceration
• Not likely to follow-up in the estimation of surgeon
• Pregnant females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Suprapatellar approach

Active Comparator group

Description:

surgical approach for intramedullary nailing of the tibia

Treatment:

Procedure: Suprapatellar approach

Infrapatellar approach

Active Comparator group

Description:

surgical approach for intramedullary nailing of the tibia

Treatment:

Procedure: Infrapatellar approach