Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135298
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-11-13
Brief Title:
FARE Augmentation of Proximal Femoral Fractures With CaSHA and Systemic ZA
Sponsor:
Aksaray University
Organization:
Aksaray University
Study Overview
Official Title:
Augmentation of Pertrochanteric Fracture Proximal Femoral Nail Osteosynthesis Using Calcium SulphateHydroxyapatite Combined With Systemic Bisphosphonate - A Pilot Study of the FARE Fracture Anchorage and Bone REgeneration Method
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate the new bone formation around a metal device in the femoral head in patients with osteoporotic hip fractures undergoing surgical treatment with nails These surgeries have a high risk of fixation failure in patients with osteoporosis due to low bone quality The main question we aim to answer are whether promoting new bone formation around the implant is possible with a bone graft substitute CERAMENT Bone Void Filler and systemic osteoporosis drug zoledronic acid combination which can strengthen the surgical fixation of the fracture Participants will consist of patients suffering hip fracture and already scheduled for surgical treatment with a nail One group will undergo conventional surgery While the other group will also undergo the same surgery they will receive CERAMENT Bone Void Filler around the implant as a short extra step during surgery This will allow the researchers to see whether new bone is formed during a 6-month follow-up
Detailed Description:
A total of 20 eligible patients with osteoporotic per trochanteric fractures that are treated with proximal femoral nail PFN will be included in the study after informed and approved consent and will be randomized into two groups Randomization will be performed by the principal investigator by sealed envelopes after determining if the patient fulfills the inclusion criteria
Following randomization all patients will be operated with PFN The control group will receive a standard surgical procedure without augmentation of the helical blade The study group will also receive 2-3 mL of CERAMENT BONE VOID FILLER 510k Number K201535 delivered using an introducer needle inserted through the helical blade of the PFN inserted in the femoral head away from the fracture site with an intent to increase bone-implant anchorage
Routine procedure for anesthesia and infection prophylaxis according to written instructions will be followed in every patient As an additional infection antibiotic prophylaxis all patients will receive a 2nd generation tetracycline ie Doxycycline 200 mg Oral dose 4 h before the start of surgery The patient will be operated supine with the fractured leg positioned in traction table In the standard protocol fluoroscopy is used to get AP and lateral view during surgery The hip region is scrubbed and dressed in sterile drapes Using standard technique a nail is inserted into the intramedullary canal after fracture reduction To insert the helical blade in the femoral neck 20 mm diameter guide wire is first placed in the femoral neck checking the fluoroscopic AP and lateral views The canal is opened using a 10 mm drill bit and the length of helical blade is measured
In addition to the standard surgical procedure in the study group after creating the canal with 10 mm drill bit and partly insertion of the helical blade the synthetic bone void filler Calcium SulphateHydroxyapatite CaSHA will be injected
After the pilot hole is created for the helical blade placement the hollow helical blade will be inserted partially with gentle blows with a hammer 25 cm from its final intended position At this point the injectable CaSHA biomaterial will be mixed as per the manufacturer guidelines and the paste will be transferred into an injection syringe At t 25 min from the start of mixing 2-3 mL of bone void filler BVF paste will be injected by a CE marked Introducer Needle connected to the injection syringe through the hollow helical blade Under fluoroscopic guidance injection will start proximal and continue while the cannula is slowly retracted towards the tip of the helical blade until the drilled space in front of the lag screw and the surrounding cancellous bone is filled with 2-3 mL of the material Finally the helical blade will be inserted to its end position with gentle blows with a hammer Remaining material approximately 2 mL still being moldable will be manually deposited in the trochanteric fracture void A very similar injection technique for application in a dynamic hip screw DHS in trochanteric fractures is described in a recently published scientific article
Patients with an osteoporotic trochanteric femoral fracture that have no contraindications should receive secondary fracture prevention with a bisphosphonate In this study all patients will receive systemic Intravenous Zoledronic acid ZA as routine All patients included in the study without any contraindication for ZA therefore will receive 5mg100ml ZA intravenously day 5 after surgery during hospitalization ZA has been shown to significantly reduce the risk of hip fracture in post-menopausal women
Following randomization all patients will be operated with PFN The control group will receive a standard surgical procedure without augmentation of the helical blade The study group will also receive 2-3 mL of CERAMENT BONE VOID FILLER 510k Number K201535 delivered using an introducer needle inserted through the helical blade of the PFN inserted in the femoral head away from the fracture site with an intent to increase bone-implant anchorage
Routine procedure for anesthesia and infection prophylaxis according to written instructions will be followed in every patient As an additional infection antibiotic prophylaxis all patients will receive a 2nd generation tetracycline ie Doxycycline 200 mg Oral dose 4 h before the start of surgery The patient will be operated supine with the fractured leg positioned in traction table In the standard protocol fluoroscopy is used to get AP and lateral view during surgery The hip region is scrubbed and dressed in sterile drapes Using standard technique a nail is inserted into the intramedullary canal after fracture reduction To insert the helical blade in the femoral neck 20 mm diameter guide wire is first placed in the femoral neck checking the fluoroscopic AP and lateral views The canal is opened using a 10 mm drill bit and the length of helical blade is measured
In addition to the standard surgical procedure in the study group after creating the canal with 10 mm drill bit and partly insertion of the helical blade the synthetic bone void filler Calcium SulphateHydroxyapatite CaSHA will be injected
After the pilot hole is created for the helical blade placement the hollow helical blade will be inserted partially with gentle blows with a hammer 25 cm from its final intended position At this point the injectable CaSHA biomaterial will be mixed as per the manufacturer guidelines and the paste will be transferred into an injection syringe At t 25 min from the start of mixing 2-3 mL of bone void filler BVF paste will be injected by a CE marked Introducer Needle connected to the injection syringe through the hollow helical blade Under fluoroscopic guidance injection will start proximal and continue while the cannula is slowly retracted towards the tip of the helical blade until the drilled space in front of the lag screw and the surrounding cancellous bone is filled with 2-3 mL of the material Finally the helical blade will be inserted to its end position with gentle blows with a hammer Remaining material approximately 2 mL still being moldable will be manually deposited in the trochanteric fracture void A very similar injection technique for application in a dynamic hip screw DHS in trochanteric fractures is described in a recently published scientific article
Patients with an osteoporotic trochanteric femoral fracture that have no contraindications should receive secondary fracture prevention with a bisphosphonate In this study all patients will receive systemic Intravenous Zoledronic acid ZA as routine All patients included in the study without any contraindication for ZA therefore will receive 5mg100ml ZA intravenously day 5 after surgery during hospitalization ZA has been shown to significantly reduce the risk of hip fracture in post-menopausal women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None