PFN-A Augmentation for Intertrochanteric Femoral Fractures
- Conditions
- Intertrochanteric Fracture
- Interventions
- Procedure: Cement augmentationProcedure: PFN-A Nail
- Registration Number
- NCT03000972
- Lead Sponsor
- Uppsala University
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- Dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Augmented Nail Cement augmentation Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+ Standard Nail PFN-A Nail Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation). Augmented Nail PFN-A Nail Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+
- Primary Outcome Measures
Name Time Method Viability of the femoral head as assessed by fluoride uptake using PET-CT 4 months postoperatively The primary endpoint is the level of fluoride uptake (standardized uptake values: SUVs) representing bone metabolism. PET-CT enables us to quantify this tridimensionally.
- Secondary Outcome Measures
Name Time Method Harris Hip Score 1 year Viability of the femoral head as assessed by fluoride uptake using PET-CT 1 year postoperatively
Trial Locations
- Locations (1)
Uppsala University Hospital
🇸🇪Uppsala, Uppsala Lan, Sweden