<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04498715</url>
  </required_header>
  <id_info>
    <org_study_id>20200723</org_study_id>
    <secondary_id>Lithuanian</secondary_id>
    <nct_id>NCT04498715</nct_id>
  </id_info>
  <brief_title>Trochanteric Femur Fracture Operated With Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate</brief_title>
  <official_title>An Open-labelled Pilot Study to Evaluate Dynamic Hip Screw System (DHS) Augmented With a Biphasic Apatite Sulphate Combined With Systemic or Local Bisphosphonate for Trochanteric Femur Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lithuanian University of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lithuanian University of Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to study the process of bone regeneration around a metal device&#xD;
      in the femoral neck canal using a synthetic bone substitute Cerament bone void filler (BVF)&#xD;
      and bisphosphonate (Zometa) locally or systemically that affects bone metabolism.&#xD;
      Furthermore, fracture healing and implant migration will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoporosis associated fragility fractures in the elderly are a societal and financial&#xD;
      burden in the western world and this burden has also started to affect developing nations.&#xD;
      With the aging of the world's population, the age quake, hip fractures are expected to reach&#xD;
      2.6 million by the year 2025, and between 4.5 to 6.3 million by the year 2050. The mortality&#xD;
      rate at 30 days after sustaining a hip fracture is up to 10%, and at one year 35% after the&#xD;
      fracture. It is further known that almost half of the survivors are unable to reach their&#xD;
      previous functional levels, partly related to the surgical treatment and fixation failure.&#xD;
&#xD;
      One fifth of all fragility fractures is in the hip with an almost equal ratio in in the&#xD;
      cervical and trochanteric regions. Hip arthroplasty and internal fixation are the two most&#xD;
      common treatment options for cervical and trochanteric femoral fractures. Healthier patients&#xD;
      with long life expectancy have better functional recovery and lower mortality when internal&#xD;
      fixation is used. However, dynamic hip screws (DHS) and intramedullary nails and screws are&#xD;
      associated with high failure rates, particularly in unstable trochanteric fractures.&#xD;
      Osteosynthesis cutout, with penetration of the cervical screw through the femoral head,&#xD;
      preceded by a neck-shaft varus tilting, is the most common reason of failure, reported in up&#xD;
      to 10% in trochanteric fractures, and in about 5% of neck fractures. In addition,&#xD;
      reoperations have been reported to be as high as 30%, where treatment of dislocated femoral&#xD;
      neck fracture with internal fixation fails and subsequently gets revised with total hip&#xD;
      arthroplasty (THA). It is well established that salvage THA following hip fractures has&#xD;
      significantly higher risk of complications compared to primary THA. The tip-apex distance has&#xD;
      been defined as a strong predictor of screw cutout, while recent studies question its&#xD;
      relevance. The bone quality, i.e. the degree of osteoporosis, on the other hand is associated&#xD;
      with failures.[4] Despite the increase in clinical awareness; adoption of secondary&#xD;
      prevention using bisphosphonates is still low, partly due to low patient adherence. Besides,&#xD;
      even if included in a dual-energy X-ray absorptiometry surveillance program, there is a&#xD;
      delayed response to bisphosphonate treatment, which has been deemed critical, during the&#xD;
      first one and half years. Augmentation increasing mechanical strength of cancellous bone in&#xD;
      osteoporotic hip fractures may lower the burden of revision, which may outweigh the related&#xD;
      additional cost. Before the operation, deciding in whom to augment is a challenge A pilot&#xD;
      study by Sirka et al. indicated that local delivery of a bisphosphonate, zoledronic acid&#xD;
      (ZA), using the calcium sulphate/hydroxyapatite(CaS/HA) biomaterial enhanced bone formation&#xD;
      in the femoral neck canal of severely osteoporotic rats. Moreover, recently, Raina et al.&#xD;
      confirmed the findings also in a screw implant-integration model in rats. Whether these&#xD;
      studies will show a similar potential in the clinical scenarios is a matter of speculation;&#xD;
      however, they do provide novel methods for augmenting bone quality in osteoporosis as well as&#xD;
      improving screw fixation. It is however important to mention that local delivery of ZA has a&#xD;
      profound effect on cancellous bone regeneration in healthy as well as osteoporotic while the&#xD;
      effect on cortical bone is minimal. A finite element modeling study by Kok et al. used&#xD;
      computer simulations to predict the effect of CaS/HA augmentation in the form of injections&#xD;
      into the human femoral heads/femoral neck canal and indicated enhanced mechanical properties&#xD;
      by up to 25% which were dependent on volume and location of the injection. In a limited&#xD;
      one-year follow up study, the use of an injectable ceramic applied in the trochanteric&#xD;
      fracture bone void has been shown to lead to adequate fracture healing with minimal DHS screw&#xD;
      migration Preliminary data from biomechanical studies in osteoporotic sawbones and donated&#xD;
      human osteoporotic femoral heads indicates that using a biphasic apatite/sulphate material&#xD;
      for reinforcing a fragile bone will result in an increase strength of the fixation of a&#xD;
      fracture device inserted in the proximal femoral canal.(in house on file It is reasonable to&#xD;
      argue that patients with high fracture and low mortality risks would benefit from an&#xD;
      augmentation procedure far more than the ones with low fracture and high mortality risks. In&#xD;
      a recent study, by combining the well-established fracture risk assessment tool (FRAX) and&#xD;
      the Sernbo score to form a fracture and mortality risk evaluation (FAME) Index, one fifth of&#xD;
      the patients could be identified as a cohort, with high risk of subsequent fracture but low&#xD;
      risk of mortality. This group could theoretically benefit from cancellous bone augmentation&#xD;
      during internal fixation of a fragility hip fracture. By utilizing a simple form, the FAME&#xD;
      Index was successfully applied in the acute setting before the operation, during history&#xD;
      taking by well-informed medical staff in less than 10 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of bone density and remodeling around the head of dynamic screw</measure>
    <time_frame>1.5, 3, 6 months</time_frame>
    <description>Bone density and remodelling around a dynamic hip screw will be investigated by CT scan using a program for alleviating metal artefacts. A 20% increase in bone density is expected to be significant and clinically relevant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Harris Hip Score (HHS) in different group patients</measure>
    <time_frame>1.5, 3 and 6 months</time_frame>
    <description>The HHS score 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 &lt;70 is considered a poor result; 70-80 is considered fair, 80-90 is good, and 90-100 is an excellent result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Screw migration by X-ray</measure>
    <time_frame>1.5, 3 and 6 months</time_frame>
    <description>Quantify dynamic hip screw (DHS®) migration on serial anteroposterior (AP) radiographs by accounting for femoral rotation and flexion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Trochanteric Fracture of Femur</condition>
  <arm_group>
    <arm_group_label>OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After osteosynthesis, systemic Zoledronic acid 4mg (or any other bisphosphonate) will be given intravenously between day 7-14 post operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During osteosynthesis, cerament BVF will be used for the augmentation of the screw. Then systemic Zoledronic acid 4mg (or any other bisphosphonate) will be given intravenously between day 7-14 post operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>OSTEOSYNTHESIS</intervention_name>
    <description>Routine procedure for anesthesia and infection prophylaxis according to the clinics routines will be followed. The patient is supine with the fractured leg positioned in traction table. The biplanar x-ray device is moved and adjusted for proper simultaneous AP and lateral view. Hip region is washed and dressed in sterile draping's. Using standard proximal femur osteosynthesis technique 2.0 mm diameter Kirschner wire is placed in the middle zone of the femoral neck in AP and lateral view. The canal is opened using 6 mm drill bit and measured length of dynamic hip screw is placed in the femoral head and neck.</description>
    <arm_group_label>OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID</arm_group_label>
    <arm_group_label>OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zoledronic Acid</intervention_name>
    <description>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, 4 mg (as per clinical protocol) will be injected intravenously 1-2 weeks after surgery. For local delivery, 1 or 2 mg Zoledronic Acid will be added to 5 or 10 mg CERAMENT BVF during mixing and the mixture will be injected.</description>
    <arm_group_label>OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID</arm_group_label>
    <arm_group_label>OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID</arm_group_label>
    <other_name>Zometa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CERAMENT BONE VOID FILLER (BVF)</intervention_name>
    <description>CERAMENT™|BONE VOID FILLER is a synthetic, injectable, osteoconductive bone void filler. CERAMENT™I is biphasic, consisting of 60% calcium sulfate and 40% hydroxyapatite mixed with the radio-opacity enhancing component CERAMENT™|C-TRU (iohexol 300 mg iodine/ml), which allows bone in-growth after curing. The high injectability of CERAMENT™ allows transcortical administration and ensures good intraosseous spread. In this trial, CERAMENT BVF paste will be injected by a sterilized metal needle (2-3 mm diameter and 15 cm length) through the hollow dynamic hip screw.</description>
    <arm_group_label>OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 65-90 years of age;&#xD;
&#xD;
          -  Fame classification with low mortality and high fracture risk.&#xD;
&#xD;
          -  Unilateral proximal hip fracture ((AO Foundation/Orthopaedic Trauma Association&#xD;
             (AO/OTA): A1 and A2)) caused by low energy trauma (physical condition eligible for&#xD;
             surgery with dynamic hip screw);&#xD;
&#xD;
          -  Patient with a communicative ability to understand the procedure and participate in&#xD;
             the study and the follow-up program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous hip or pelvic fractures on the same side,&#xD;
&#xD;
          -  Concurrent oral treatment with corticosteroids, and/or osteoporosis medication&#xD;
&#xD;
          -  Irreversible coagulopathy or bleeding disorder. Note regarding reversible&#xD;
             coagulopathies: Patients on coumadin or other anticoagulants may participate.&#xD;
             Investigators should follow routine practices for perioperative discontinuation and&#xD;
             re-initiation of anticoagulants;&#xD;
&#xD;
          -  Concurrent dialysis or elevated creatinine&#xD;
&#xD;
          -  Hypo or hyper calcaemia&#xD;
&#xD;
          -  Active treatment due to malignancy including ongoing or completed radiotherapy&#xD;
             involving the pelvis/hip area,&#xD;
&#xD;
          -  Fractures involving acetabulum&#xD;
&#xD;
          -  Active systemic infection or local skin infection at the incision site&#xD;
&#xD;
          -  Known hyperthyroidism or thyroid adenoma,&#xD;
&#xD;
          -  History of serious reaction to iodine based radio contrast agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarunas Tarasevicius, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lithuanian University of Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarunas Tarasevicius, MD,PhD</last_name>
    <phone>+37037326282</phone>
    <email>sarunas.tarasevicius@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kaunas Clinics</name>
      <address>
        <city>Kaunas</city>
        <country>Lithuania</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sarunas Tarasevicius, MD,PhD</last_name>
      <phone>+37037312699</phone>
      <email>sarunas.tarasevicius@lsmuni.lt</email>
    </contact>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.3389/fbioe.2022.816250</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Raina 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.</citation>
    <PMID>35309986</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lithuanian University of Health Sciences</investigator_affiliation>
    <investigator_full_name>Sarunas Tarasevicius</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Dynamic hip screw (DHS)</keyword>
  <keyword>Biphasic apatite sulphate ceramic</keyword>
  <keyword>bisphosphonate-zoledronic acid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zoledronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data will be shared after the study finished.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>5-10 years after study finished.</ipd_time_frame>
    <ipd_access_criteria>Universities, hospitals and research institutions.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04498715
org study id: 20200723
secondary id: Lithuanian
nct id: NCT04498715
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to study the process of bone regeneration around a metal device
      in the femoral neck canal using a synthetic bone substitute Cerament bone void filler (BVF)
      and bisphosphonate (Zometa) locally or systemically that affects bone metabolism.
      Furthermore, fracture healing and implant migration will be investigated.
Osteoporosis associated fragility fractures in the elderly are a societal and financial
      burden in the western world and this burden has also started to affect developing nations.
      With the aging of the world's population, the age quake, hip fractures are expected to reach
      2.6 million by the year 2025, and between 4.5 to 6.3 million by the year 2050. The mortality
      rate at 30 days after sustaining a hip fracture is up to 10%, and at one year 35% after the
      fracture. It is further known that almost half of the survivors are unable to reach their
      previous functional levels, partly related to the surgical treatment and fixation failure.

      One fifth of all fragility fractures is in the hip with an almost equal ratio in in the
      cervical and trochanteric regions. Hip arthroplasty and internal fixation are the two most
      common treatment options for cervical and trochanteric femoral fractures. Healthier patients
      with long life expectancy have better functional recovery and lower mortality when internal
      fixation is used. However, dynamic hip screws (DHS) and intramedullary nails and screws are
      associated with high failure rates, particularly in unstable trochanteric fractures.
      Osteosynthesis cutout, with penetration of the cervical screw through the femoral head,
      preceded by a neck-shaft varus tilting, is the most common reason of failure, reported in up
      to 10% in trochanteric fractures, and in about 5% of neck fractures. In addition,
      reoperations have been reported to be as high as 30%, where treatment of dislocated femoral
      neck fracture with internal fixation fails and subsequently gets revised with total hip
      arthroplasty (THA). It is well established that salvage THA following hip fractures has
      significantly higher risk of complications compared to primary THA. The tip-apex distance has
      been defined as a strong predictor of screw cutout, while recent studies question its
      relevance. The bone quality, i.e. the degree of osteoporosis, on the other hand is associated
      with failures.[4] Despite the increase in clinical awareness; adoption of secondary
      prevention using bisphosphonates is still low, partly due to low patient adherence. Besides,
      even if included in a dual-energy X-ray absorptiometry surveillance program, there is a
      delayed response to bisphosphonate treatment, which has been deemed critical, during the
      first one and half years. Augmentation increasing mechanical strength of cancellous bone in
      osteoporotic hip fractures may lower the burden of revision, which may outweigh the related
      additional cost. Before the operation, deciding in whom to augment is a challenge A pilot
      study by Sirka et al. indicated that local delivery of a bisphosphonate, zoledronic acid
      (ZA), using the calcium sulphate/hydroxyapatite(CaS/HA) biomaterial enhanced bone formation
      in the femoral neck canal of severely osteoporotic rats. Moreover, recently, Raina et al.
      confirmed the findings also in a screw implant-integration model in rats. Whether these
      studies will show a similar potential in the clinical scenarios is a matter of speculation;
      however, they do provide novel methods for augmenting bone quality in osteoporosis as well as
      improving screw fixation. It is however important to mention that local delivery of ZA has a
      profound effect on cancellous bone regeneration in healthy as well as osteoporotic while the
      effect on cortical bone is minimal. A finite element modeling study by Kok et al. used
      computer simulations to predict the effect of CaS/HA augmentation in the form of injections
      into the human femoral heads/femoral neck canal and indicated enhanced mechanical properties
      by up to 25% which were dependent on volume and location of the injection. In a limited
      one-year follow up study, the use of an injectable ceramic applied in the trochanteric
      fracture bone void has been shown to lead to adequate fracture healing with minimal DHS screw
      migration Preliminary data from biomechanical studies in osteoporotic sawbones and donated
      human osteoporotic femoral heads indicates that using a biphasic apatite/sulphate material
      for reinforcing a fragile bone will result in an increase strength of the fixation of a
      fracture device inserted in the proximal femoral canal.(in house on file It is reasonable to
      argue that patients with high fracture and low mortality risks would benefit from an
      augmentation procedure far more than the ones with low fracture and high mortality risks. In
      a recent study, by combining the well-established fracture risk assessment tool (FRAX) and
      the Sernbo score to form a fracture and mortality risk evaluation (FAME) Index, one fifth of
      the patients could be identified as a cohort, with high risk of subsequent fracture but low
      risk of mortality. This group could theoretically benefit from cancellous bone augmentation
      during internal fixation of a fragility hip fracture. By utilizing a simple form, the FAME
      Index was successfully applied in the acute setting before the operation, during history
      taking by well-informed medical staff in less than 10 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of bone density and remodeling around the head of dynamic screw
time frame: 1.5, 3, 6 months
description: Bone density and remodelling around a dynamic hip screw will be investigated by CT scan using a program for alleviating metal artefacts. A 20% increase in bone density is expected to be significant and clinically relevant.
measure: Change of Harris Hip Score (HHS) in different group patients
time frame: 1.5, 3 and 6 months
description: The HHS score 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.
measure: Change of the Screw migration by X-ray
time frame: 1.5, 3 and 6 months
description: Quantify dynamic hip screw (DHS®) migration on serial anteroposterior (AP) radiographs by accounting for femoral rotation and flexion.
arm group label: OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID
arm group type: Active Comparator
description: After osteosynthesis, systemic Zoledronic acid 4mg (or any other bisphosphonate) will be given intravenously between day 7-14 post operation.
arm group label: OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID
arm group type: Experimental
description: During osteosynthesis, cerament BVF will be used for the augmentation of the screw. Then systemic Zoledronic acid 4mg (or any other bisphosphonate) will be given intravenously between day 7-14 post operation.
intervention type: Procedure
intervention name: OSTEOSYNTHESIS
description: Routine procedure for anesthesia and infection prophylaxis according to the clinics routines will be followed. The patient is supine with the fractured leg positioned in traction table. The biplanar x-ray device is moved and adjusted for proper simultaneous AP and lateral view. Hip region is washed and dressed in sterile draping's. Using standard proximal femur osteosynthesis technique 2.0 mm diameter Kirschner wire is placed in the middle zone of the femoral neck in AP and lateral view. The canal is opened using 6 mm drill bit and measured length of dynamic hip screw is placed in the femoral head and neck.
arm group label: OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID
arm group label: OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID
intervention type: Drug
intervention name: Zoledronic Acid
description: 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, 4 mg (as per clinical protocol) will be injected intravenously 1-2 weeks after surgery. For local delivery, 1 or 2 mg Zoledronic Acid will be added to 5 or 10 mg CERAMENT BVF during mixing and the mixture will be injected.
arm group label: OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID
arm group label: OSTEOSYNTHESIS+SYSTEMIC ZOLEDRONIC ACID
other name: Zometa
intervention type: Device
intervention name: CERAMENT BONE VOID FILLER (BVF)
description: CERAMENT™|BONE VOID FILLER is a synthetic, injectable, osteoconductive bone void filler. CERAMENT™I is biphasic, consisting of 60% calcium sulfate and 40% hydroxyapatite mixed with the radio-opacity enhancing component CERAMENT™|C-TRU (iohexol 300 mg iodine/ml), which allows bone in-growth after curing. The high injectability of CERAMENT™ allows transcortical administration and ensures good intraosseous spread. In this trial, CERAMENT BVF paste will be injected by a sterilized metal needle (2-3 mm diameter and 15 cm length) through the hollow dynamic hip screw.
arm group label: OSTEOSYNTHESIS+LOCAL CERAMENT BONE VOID FILLER (BVF)+SYSTEMIC ZOLEDRONIC ACID
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sarunas Tarasevicius, MD,PhD
role: Principal Investigator
affiliation: Lithuanian University of Health Sciences
last name: Sarunas Tarasevicius, MD,PhD
phone: +37037326282
email: sarunas.tarasevicius@gmail.com
facility: 
status: Recruiting
contact: 
country: Lithuania
url: https://doi.org/10.3389/fbioe.2022.816250
description: Related Info
citation: Raina 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.
PMID: 35309986
responsible party type: Principal Investigator
investigator affiliation: Lithuanian University of Health Sciences
investigator full name: Sarunas Tarasevicius
investigator title: Professor
mesh term: Fractures, Bone
mesh term: Femoral Fractures
mesh term: Hip Fractures
mesh term: Zoledronic Acid
sharing ipd: Yes
ipd description: Individual participant data will be shared after the study finished.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 5-10 years after study finished.
ipd access criteria: Universities, hospitals and research institutions.