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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Nail | Active Comparator | Hip fracture surgery with a PFN-A Nail (Proximal Femoral Nail Augmentation). |
|
| Augmented Nail | Experimental | Hip fracture surgery with a PFN-A Nail with Cement augmentation with TraumaCemV+ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cement augmentation | Procedure |
| ||
| PFN-A Nail |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Viability of the femoral head as assessed by fluoride uptake using PET-CT | Within 1 week postoperatively | |
| Viability of the femoral head as assessed by fluoride uptake using PET-CT | 1 year postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olof Wolf, MD PhD | Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala University Hospital | Uppsala | Uppsala County | 75185 | Sweden |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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|
| Harris Hip Score | 4 months |
| Harris Hip Score | 1 year |
| D007869 |
| Leg Injuries |