PFN-A Augmentation for Intertrochanteric Femoral Fractures

Intertrochanteric Fracture Clinical Trial

Official title:

PFN-A Intramedullary Nail and Intertrochanteric Hip Fracture. Augmentation of the Femoral Head Assessed by PET-CT (Positron Emission Tomography - Computed Tomography)- a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000972
• Other study ID #: PFNA
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: October 2017

Study information

• Verified date: May 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures
• Intertrochanteric Fracture

Intervention

Procedure:
• Cement augmentation

• PFN-A Nail

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala	Uppsala Lan

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viability of the femoral head as assessed by fluoride uptake using PET-CT	The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.	4 months postoperatively
Secondary	Viability of the femoral head as assessed by fluoride uptake using PET-CT		Within 1 week postoperatively
Secondary	Viability of the femoral head as assessed by fluoride uptake using PET-CT		1 year postoperatively
Secondary	Harris Hip Score		4 months
Secondary	Harris Hip Score		1 year