Trochanteric Fracture of FemurPhase 4NCT06135298
FARE Augmentation of Proximal Femoral Fractures With CaS/HA and Systemic ZA
A Phase 4 study testing OSTEOSYNTHESIS, Zoledronic acid and CERAMENT BONE VOID FILLER (BVF) in people with Trochanteric Fracture of Femur and Osteoporotic Fracture of Femur, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Trochanteric Fracture of Femur, Osteoporotic Fracture of Femur, Hip Fractures
- What is being tested?
- OSTEOSYNTHESIS, Zoledronic acid and CERAMENT BONE VOID FILLER (BVF)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 15 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Being between 65-90 years of age at the time of fracture
- Acute, unilateral proximal hip fracture (AO Foundation/Orthopaedic Trauma Association [AO/OTA]: A1 and A2) caused by low energy trauma
- Physical condition eligible for surgery with proximal femoral nail
- Having low mortality and high fracture risk according to Fracture and Mortality Risk Evaluation Index (FAME) classification
- Patient with communicative ability to understand the procedure and participate in the study and the follow-up program, consented to be included in the study and signed the consent form
Who cannot join
- Previous hip or pelvis fracture on the same side
- Concurrent corticosteroid treatment
- Concurrent medical osteoporosis treatment
- Irreversible coagulopathy or bleeding disorder.
- o Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators will follow routine practices for perioperative discontinuation and re-initiation of anti-coagulants.
- Concurrent dialysis or elevated creatinine
Show all 13Show fewer
- Presence of hypo- or hyper calcaemia
- History or active treatment due to malignancy involving the pelvis/hip area, including ongoing or completed radiotherapy
- Fractures involving acetabulum
- Active systemic infection or local skin infection at the incision site
- Known hyperthyroidism or thyroid adenoma,
- History of serious reaction to iodine-based radio contrast agents
- Patient without communicative ability to understand the procedure and participate in the study and the follow-up program, did not consent to be included in the study and/or did not sign the consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aksaray University Training and Research Hospital
Aksaray, Aksaray, 68200
About this study
Official title: Augmentation of Pertrochanteric Fracture Proximal Femoral Nail Osteosynthesis Using Calcium Sulphate/Hydroxyapatite Combined With Systemic Bisphosphonate - A Pilot Study of the FARE (Fracture Anchorage and Bone REgeneration) Method
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.
Read the 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 (510(k) 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. For infection infection prophylaxis, 2g cefazolin will be administered 1 hour preoperatively as well as 100 mg doyxcycline 2 hours preoperatively and 6 hours postoperatively. 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, 2.0 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 Sulphate/Hydroxyapatite (CaS/HA) 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, 2.5 cm from its final intended position. At this point, the injectable CaS/HA biomaterial will be mixed as per the manufacturer guidelines and the paste will be transferred into an injection syringe. At t = 2.5 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 5mg/100ml ZA intravenously day 5 after surgery, during hospitalization. ZA has been shown to significantly reduce the risk of hip fracture in post-menopausal women.
- Conditions
- Trochanteric Fracture of Femur, Osteoporotic Fracture of Femur, Hip Fractures, Bone Density, Low
- Being tested
- OSTEOSYNTHESIS, Zoledronic acid, CERAMENT BONE VOID FILLER (BVF)
- Keywords
- Proximal femoral nail (PFN), Biphasic apatite sulphate ceramic, Zoledronic acid, Augmentation, Bone regeneration
- Medical subject headings
- Hip Fractures, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSTEOSYNTHESISProcedure or surgery
Also called Proximal femoral nail with helical blade
Routine procedure for anesthesia and infection prophylaxis according to written instructions will be followed in every patient. The patient will be operated supine with the fractured leg positioned in traction table. 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, 2.0 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. After the pilot hole is created for the helical blade placement, the hollow helical blade will be inserted to its end position with gentle blows with a hammer.
Zoledronic acidDrug
Also called Ronidro 5mg/Bag 100 mL Inj
Zoledronic acid (ZA), is a bisphosphonate, and has been shown to reduce the risk of hip fracture by 41% in post-menopausal women. For systemic injection, 5 mg (as per clinical protocol) will be injected intravenously 5 days after surgery, during hospitalization.
CERAMENT BONE VOID FILLER (BVF)Device
Also called CaS/HA
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 CaS/HA will be injected. The helical blade will be inserted partially with gentle blows with a hammer, 2.5 cm from its final intended position. The injectable CaS/HA biomaterial will be mixed as per the manufacturer guidelines and the paste will be transferred into an injection syringe. At t = 2.5 min from the start of mixing, 2-3 mL of BVF paste will be injected by a CE marked Introducer Needle connected to the injection syringe, through the hollow helical blade. 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.
| Study group | Role | What they receive |
|---|---|---|
| OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID | Active comparator | After osteosynthesis, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization. Receives: Procedure: OSTEOSYNTHESIS; Drug: Zoledronic acid |
| OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID | Experimental | During osteosynthesis, cerament BVF will be used for the augmentation of the helical blade. Then, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization. Receives: Procedure: OSTEOSYNTHESIS; Drug: Zoledronic acid; Device: CERAMENT BONE VOID FILLER (BVF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of bone density around the helical blade of proximal femoral nail
Change of bone density measured by Dual-energy X-ray absorptiometry (DEXA) scan of bilateral proximal femurs will be evaluated. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.
Measured: 1-week and 6 months after the surgery
Bone remodeling around the helical blade of proximal femoral nail
Bone remodeling around the helical blade will be evaluated by computerized tomography (CT) scan of the pelvis using a program for alleviating metal artefacts. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.
Measured: 1-week and 6 months after the surgery
Secondary outcomes (4)
Harris Hip Score
The Harris Hip Score (HHS) has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). The higher the HHS, the less dysfunction. A total score of <70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result.
Measured: 1-week and 6 months after the surgery
Screw position and migration by X-ray
X-ray evaluation will quantify helical blade migration on anteroposterior (AP) radiographs by two investigators independently, accounting for femoral rotation and flexion.
Measured: 1-week and 6 months after the surgery
Evaluation of fracture union
Radiographic evaluation will be performed by two investigators independently to decide whether fracture fixation resulted with union or non-union.
Measured: 6 months after the surgery
Any mechanical complications
Any mechanical complications related to the implant will be recorded.
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Jul 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trochanteric Fracture of FemurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 20 eligible patients with osteoporotic per trochanteric fractures, that are scheduled to be 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University Hospital
- Responsible party
- Principal investigator, Erdem Aras Sezgin, Aksaray University
- Investigators
- Erdem Aras Sezgin, MD, Principal investigator, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135298
- Sponsor's protocol ID
- 2023/1702
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. doi: 10.1056/NEJMoa067312.
PubMed 17476007Raina DB, Markeviciute V, Stravinskas M, Kok J, Jacobson I, Liu Y, Sezgin EA, Isaksson H, Zwingenberger S, Tagil M, Tarasevicius S, Lidgren L. A New Augmentation Method for Improved Screw Fixation in Fragile Bone. Front Bioeng Biotechnol. 2022 Mar 2;10:816250. doi: 10.3389/fbioe.2022.816250. eCollection 2022.
PubMed 35309986Sezgin EA, Tor AT, Markeviciute V, Sirka A, Tarasevicius S, Raina DB, Liu Y, Isaksson H, Tagil M, Lidgren L. A combined fracture and mortality risk index useful for treatment stratification in hip fragility fractures. Jt Dis Relat Surg. 2021;32(3):583-589. doi: 10.52312/jdrs.2021.382. Epub 2021 Nov 19.
PubMed 34842088
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Pertrochanteric Fracture Proximal Femoral Nail Osteosynthesis Using Calcium Sulphate/Hydroxyapatite Combined With Systemic Bisphosphonate - A Pilot Study of the FARE (Fracture Anchorage and Bone REgeneration) Method
- ClinicalTrials.gov ID
- NCT06135298
- Acronym / sponsor ID
- 2023/1702
- Conditions
- Trochanteric Fracture of Femur, Osteoporotic Fracture of Femur, Hip Fractures, Bone Density, Low
- Keywords
- Proximal femoral nail (PFN), Biphasic apatite sulphate ceramic, Zoledronic acid, Augmentation, Bone regeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Collaborators
- Lund University Hospital
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (510(k) 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. For infection infection prophylaxis, 2g cefazolin will be administered 1 hour preoperatively as well as 100 mg doyxcycline 2 hours preoperatively and 6 hours postoperatively. 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, 2.0 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 Sulphate/Hydroxyapatite (CaS/HA) 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, 2.5 cm from its final intended position. At this point, the injectable CaS/HA biomaterial will be mixed as per the manufacturer guidelines and the paste will be transferred into an injection syringe. At t = 2.5 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 5mg/100ml 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A total of 20 eligible patients with osteoporotic per trochanteric fractures, that are scheduled to be 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.
| Arm | Type | Receives |
|---|---|---|
| OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID | Active comparator | Procedure: OSTEOSYNTHESIS, Drug: Zoledronic acidAfter osteosynthesis, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization. |
| OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID | Experimental | Procedure: OSTEOSYNTHESIS, Drug: Zoledronic acid, Device: CERAMENT BONE VOID FILLER (BVF)During osteosynthesis, cerament BVF will be used for the augmentation of the helical blade. Then, systemic Zoledronic acid 5mg will be given intravenously at day 5 after surgery, during hospitalization. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Being between 65-90 years of age at the time of fracture
- Acute, unilateral proximal hip fracture (AO Foundation/Orthopaedic Trauma Association [AO/OTA]: A1 and A2) caused by low energy trauma
- Physical condition eligible for surgery with proximal femoral nail
- Having low mortality and high fracture risk according to Fracture and Mortality Risk Evaluation Index (FAME) classification
- Patient with communicative ability to understand the procedure and participate in the study and the follow-up program, consented to be included in the study and signed the consent form
Key exclusion criteria (13 listed)
- Previous hip or pelvis fracture on the same side
- Concurrent corticosteroid treatment
- Concurrent medical osteoporosis treatment
- Irreversible coagulopathy or bleeding disorder.
- o Note regarding reversible coagulopathies: Patients on coumadin or other anticoagulants may participate. Investigators will follow routine practices for perioperative discontinuation and re-initiation of anti-coagulants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSTEOSYNTHESISAlso: Proximal femoral nail with helical bladeRoutine procedure for anesthesia and infection prophylaxis according to written instructions will be followed in every patient. The patient will be operated supine with the fractured leg positioned in traction table. 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, 2.0 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. After the pilot hole is created for the helical blade placement, the hollow helical blade will be inserted to its end position with gentle blows with a hammer. | Procedure or surgery | OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID, OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID |
| Zoledronic acidAlso: Ronidro 5mg/Bag 100 mL InjZoledronic acid (ZA), is a bisphosphonate, and has been shown to reduce the risk of hip fracture by 41% in post-menopausal women. For systemic injection, 5 mg (as per clinical protocol) will be injected intravenously 5 days after surgery, during hospitalization. | Drug | OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID, OSTEOSYNTHESIS + SYSTEMIC ZOLEDRONIC ACID |
| CERAMENT BONE VOID FILLER (BVF)Also: CaS/HAIn 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 CaS/HA will be injected. The helical blade will be inserted partially with gentle blows with a hammer, 2.5 cm from its final intended position. The injectable CaS/HA biomaterial will be mixed as per the manufacturer guidelines and the paste will be transferred into an injection syringe. At t = 2.5 min from the start of mixing, 2-3 mL of BVF paste will be injected by a CE marked Introducer Needle connected to the injection syringe, through the hollow helical blade. 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. | Device | OSTEOSYNTHESIS + LOCAL CERAMENT BONE VOID FILLER (BVF) + SYSTEMIC ZOLEDRONIC ACID |
Primary outcome
Change of bone density around the helical blade of proximal femoral nail
Time frame: 1-week and 6 months after the surgery
Change of bone density measured by Dual-energy X-ray absorptiometry (DEXA) scan of bilateral proximal femurs will be evaluated. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.
Bone remodeling around the helical blade of proximal femoral nail
Time frame: 1-week and 6 months after the surgery
Bone remodeling around the helical blade will be evaluated by computerized tomography (CT) scan of the pelvis using a program for alleviating metal artefacts. A 10 % increase in bone density / bone volume in the femoral head adjacent to the helical blade is expected to be significant and clinically relevant.
4 secondary outcomes
Harris Hip Score
Time frame: 1-week and 6 months after the surgery
Screw position and migration by X-ray
Time frame: 1-week and 6 months after the surgery
Evaluation of fracture union
Time frame: 6 months after the surgery
Any mechanical complications
Time frame: 6 months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 17476007Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22. doi: 10.1056/NEJMoa067312.
- Results publication: PubMed 35309986Raina DB, Markeviciute V, Stravinskas M, Kok J, Jacobson I, Liu Y, Sezgin EA, Isaksson H, Zwingenberger S, Tagil M, Tarasevicius S, Lidgren L. A New Augmentation Method for Improved Screw Fixation in Fragile Bone. Front Bioeng Biotechnol. 2022 Mar 2;10:816250. doi: 10.3389/fbioe.2022.816250. eCollection 2022.
- Results publication: PubMed 34842088Sezgin EA, Tor AT, Markeviciute V, Sirka A, Tarasevicius S, Raina DB, Liu Y, Isaksson H, Tagil M, Lidgren L. A combined fracture and mortality risk index useful for treatment stratification in hip fragility fractures. Jt Dis Relat Surg. 2021;32(3):583-589. doi: 10.52312/jdrs.2021.382. Epub 2021 Nov 19.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdem Aras Sezgin, MD principal investigator
Aksaray University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OSTEOSYNTHESIS, Zoledronic acid and CERAMENT BONE VOID FILLER (BVF) in people with Trochanteric Fracture of Femur and Osteoporotic Fracture of Femur, run by Aksaray University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of bone density around the helical blade of proximal femoral nail (time frame: 1-week and 6 months after the surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06135298, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.