Clinical Trials Logo

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03000972
Study type Interventional
Source Uppsala University
Status Completed
Phase N/A
Start date January 2014
Completion date October 2017

See also
  Status Clinical Trial Phase
Recruiting NCT01437176 - Treatment of Intertrochanteric Fracture With New Type of Intramedullary Nail Phase 4
Recruiting NCT01797237 - Outcome Comparison Between PFNA and InterTAN Phase 4
Active, not recruiting NCT02627040 - Intertrochanteric Femoral Fracture Fixation Trial N/A
Completed NCT00555945 - Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN) N/A
Completed NCT02512094 - Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients N/A
Completed NCT01380444 - Intramedullary Nail Versus Sliding Hip Screw Inter-Trochanteric Evaluation N/A