PFN-A Augmentation for Intertrochanteric Femoral Fractures

Uppsala University

Status: Completed

Conditions: Intertrochanteric Fracture

Treatments: Procedure: PFN-A Nail; Procedure: Cement augmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT03000972

PFNA

Details and patient eligibility

About

This study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. Half of the participants will have the standard intramedullary nail (PFN-A; Proximal Femoral Nail Augmentation), while the other half will get the standard nail plus cement augmentation.

Full description

Cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. The cement used in previous studies has produced heat and thermal necrosis on bone cells. The cement used in this study (TraumaCemV+) is manufactured specially for this implant and for the augmentation of this implant. TraumaCemV sets under low temperature (40 degrees Celsius) and we do not anticipate any heat necrosis. The volume effect of the cement could theoretically also damage the blood flow in the femoral head. There have been no negative effects in big series of patients operated with this technique.

The aim of this study is to quantify the viability of the femoral head with the use PET-CT (Positron Emission Tomography with simultaneous Computed Tomography) including a radioactive isotope (Fluorine-18) and the use of threedimensional computed tomography.

Enrollment: 20 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intertrochanteric Hip Fracture AO (Arbeitsgemeinschaft für Osteosynthesefragen) 31-A1 or AO 31-A2
• Healthy contralateral hip
• ASA (American Society of Anesthesiologists) Physical Status Class I or II

Exclusion criteria

• Dementia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Standard Nail

Active Comparator group

Description:

Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation).

Treatment:

Procedure: PFN-A Nail

Augmented Nail

Experimental group

Description:

Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+

Treatment:

Procedure: Cement augmentation

Procedure: PFN-A Nail