xml: <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/NCT05992038</url>
    </required_header>
    <id_info>
      <org_study_id>84534</org_study_id>
      <nct_id>NCT05992038</nct_id>
    </id_info>
    <brief_title>Use of a Putty as Gap Filler in Open-wedge Osteotomy</brief_title>
    <acronym>AXOS</acronym>
    <official_title>A Randomized Controlled Trial of AttraX® Putty vs. Conventional Open-wedge Osteotomy Without Gap Filler in Open-wedge Osteotomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>UMC Utrecht</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>UMC Utrecht</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Rationale: Realignment osteotomies around the knee are a proven surgical treatment for&#xD;
        unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in&#xD;
        the early postoperative phase. This is probably due to a combination of bony cut (bone pain)&#xD;
        and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft&#xD;
        tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to&#xD;
        potentially reduce postoperative pain by reducing the bleeding from the bone gap.&#xD;
  &#xD;
        Objective: The main aim of this study is to determine whether early postoperative pain is&#xD;
        decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open&#xD;
        wedge osteotomy without filling the gap. The secondary aims are faster accelerated&#xD;
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,&#xD;
        comparable surgical accuracy, and the occurrence of (serious) adverse events.&#xD;
  &#xD;
        Study design: Single-blinded, prospective, randomized controlled trial.&#xD;
  &#xD;
        Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double&#xD;
        level osteotomy.&#xD;
  &#xD;
        Intervention: According to a randomization scheme, the osteotomy gap will be filled with&#xD;
        either the synthetic ceramic material AttraX® Putty or without a gap filler (conventional&#xD;
        method).&#xD;
  &#xD;
        Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS)&#xD;
        pain during the first week postoperative. The secondary study endpoints are faster&#xD;
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,&#xD;
        comparable surgical accuracy, and (serious) adverse events.&#xD;
  &#xD;
        Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
        relatedness: Patients may have the advantage of experiencing less pain postoperatively if&#xD;
        they are treated with the AttraX® Putty, which can contribute to a faster rehabilitation.&#xD;
        Risks to the AttraX® Putty group may include an allergic reaction, failure to promote bone&#xD;
        fusion and excessive bone growth. However, the preclinical studies and clinical studies show&#xD;
        that the use of AttraX® Putty is safe for use in humans.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: Realignment osteotomies around the knee are a proven surgical treatment for&#xD;
        unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in&#xD;
        the early postoperative phase. This is probably due to a combination of bony cut (bone pain)&#xD;
        and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft&#xD;
        tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to&#xD;
        potentially reduce postoperative pain by reducing the bleeding from the bone gap.&#xD;
  &#xD;
        AttraX® Putty: AttraX® putty is a synthetic ceramic which consists of calcium phosphate&#xD;
        granules and hydroxyapatite (ß-tricalcium phosphate (&gt;90%)/hydroxyapatite(&lt;10%)). It is&#xD;
        Conformité Européenne (CE) marked as bone void filler and bone haemostasis implant. Unlike&#xD;
        most other synthetic bone grafts which are only osteoconductive, AttraX Putty is both&#xD;
        osteoconductive and osteoinductive. Moreover, AttraX® Putty could overcome the disadvantages&#xD;
        of using autologous bone grafts and allografts, such as, donor site morbidity, increased&#xD;
        surgical time, and disease transmission. Animal studies and a clinical study showed no&#xD;
        difference in bone fusion between AttraX® Putty and autograft after instrumented&#xD;
        thoracolumbar fusion.&#xD;
  &#xD;
        Objectives: The main aim of this study is to determine whether early postoperative pain is&#xD;
        decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open&#xD;
        wedge osteotomy without filling the gap. The secondary aims are faster accelerated&#xD;
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,&#xD;
        comparable surgical accuracy, and the occurrence of (serious) adverse events.&#xD;
  &#xD;
        Study design: Single-blinded, prospective, randomized controlled trial.&#xD;
  &#xD;
        Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double&#xD;
        level osteotomy. A total of 40 patients will be included, 20 patients in the control group&#xD;
        (without gap filler) and 20 patients in the AttraX Putty group (with AttraX® Putty as gap&#xD;
        filler). Osteotomy in combinations with cartilage treatment and corrections above 10 mm will&#xD;
        be excluded.&#xD;
  &#xD;
        Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS)&#xD;
        pain during the first week postoperative. The secondary study endpoints are the NRS pain&#xD;
        during the second week, at 1 months, and at 3 months. Moreover, faster&#xD;
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,&#xD;
        comparable surgical accuracy, and (serious) adverse events are secondary endpoints.&#xD;
  &#xD;
        Study procedures: According to standard care, standing anteroposterior and lateral&#xD;
        radiographs will be taken postoperatively during hospitalization. The subsequent follow-up&#xD;
        moments will take place at the outpatient clinic. The follow-up moments take place at +1&#xD;
        month, +4 months, +6 months, and +1 year postoperatively at the outpatient clinic. The&#xD;
        follow-up moment of +6 months is extra for this study. During this extra follow-up moment, a&#xD;
        CT scan of the lower limb (+6 months postoperative) will be performed to be able to draw a&#xD;
        conclusion about the bone union.&#xD;
  &#xD;
        According to standard care, radiographs are performed at +1 day, +1 month, +4 months, and +1&#xD;
        year. An extra radiograph will be performed at +6 months. Using these radiographs, a&#xD;
        conclusion can be drawn about the union rate and osteotomy accuracy.&#xD;
  &#xD;
        Moreover, the preoperative and postoperative (+1 day) haemoglobin value will be analysed,&#xD;
        according to standard care. Using the haemoglobin value one of the secondary outcomes can be&#xD;
        determined (difference in haemoglobin value between preoperative and postoperative).&#xD;
  &#xD;
        The rest of the data will be collected at -1 week, +1 day, +1 week, +2 weeks, +3 weeks, +1&#xD;
        months, + 3 months, +4 months, +6 months, and +1 year postoperatively. This will involve&#xD;
        questionnaires (Knee Injury and Osteoarthritis Outcome Score (KOOS), EuroQol Five Dimensions&#xD;
        Health Questionnaire (EQ-5D) and Kujala Patellofemoral Score), the NRS pain score, and&#xD;
        measuring the calf or upper leg circumference. The calf or upper leg circumference is&#xD;
        measured at the site where the open wedge osteotomy was performed. For a double-level&#xD;
        osteotomy, it depends on where the open wedge osteotomy has taken place: the femur or the&#xD;
        tibia. The location where the calf or upper leg circumference is to be measured will be&#xD;
        marked with a marker. The patient will be given a tape measure to take home to measure the&#xD;
        circumference in the morning. Using these data, the primary outcome and secondary outcomes&#xD;
        can be answered.&#xD;
  &#xD;
        If there is an indication for removal of the plate osteosynthesis (for example complaints of&#xD;
        the plate after one year postoperative), the plate will be surgically removed, and a fine&#xD;
        needle biopsy will be taken to analyse the newly formed bone. When indicated, the removal of&#xD;
        the plate osteosynthesis will take place in the period from 12 months to 18 months&#xD;
        postoperative.&#xD;
  &#xD;
        Benefits and risks: Patients have the advantage of being checked more closely during&#xD;
        follow-up. In addition, patients may have the advantage of experiencing less pain&#xD;
        postoperatively if they are into the AttraX Putty group, which can contribute to an&#xD;
        accelerated rehabilitation. Risks to the AttraX Putty group may include an allergic reaction,&#xD;
        failure to promote bone fusion and excessive bone growth. However, the preclinical studies&#xD;
        and clinical studies show that the use of AttraX® Putty is safe. Moreover, an extra CT scan&#xD;
        and radiography are performed during this study. You will receive approximately 0.1&#xD;
        millisievert (mSv) of additional radiation because of this CT scan. By way of comparison: the&#xD;
        'ordinary' radiation that everyone in the Netherlands receives anyway is about ~2.9 mSv per&#xD;
        year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The mean NRS pain score</measure>
      <time_frame>First week postoperative daily score</time_frame>
      <description>Questionnaire to measure pain.The NRS score is a score between 0 and 10, where 0 means no pain and 10 means the most pain imaginable.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rehabilitation time</measure>
      <time_frame>After surgery (+2 weeks, +1 months, +3 months, +6 months, +1 year)</time_frame>
      <description>Time of rehabilitation period (questionnaires)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction of local blood loss</measure>
      <time_frame>Before surgery and 1 day after surgery</time_frame>
      <description>Amount of blood loss during surgery using haemoglobin measurements</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction of local blood loss</measure>
      <time_frame>Before surgery and a weekly home measurement up to and including 1 month after surgery.</time_frame>
      <description>Amount of blood loss during surgery using calf circumference</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Union rate</measure>
      <time_frame>+1 months, +4 months, +6months, and +12 months</time_frame>
      <description>Bone union determined on xray and CT-scan</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative NRS pain score</measure>
      <time_frame>After surgery (second week daily score), +1 months, +3months</time_frame>
      <description>Questionnaire to measure pain.The NRS score is a score between 0 and 10, where 0 means no pain and 10 means the most pain imaginable.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Osteo Arthritis Knee</condition>
    <arm_group>
      <arm_group_label>Putty</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The osteotomy gap will be filled with a synthetic ceramic material, Putty</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Osteotomy performed according to the conventional method, without gap filler</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Osteotomy with putty</intervention_name>
      <description>Synthetic ceramic putty</description>
      <arm_group_label>Putty</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Conventional osteotomy</intervention_name>
      <description>conventional osteotomy</description>
      <arm_group_label>Conventional</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  indication for an open-wedge osteotomy of the femur, tibia or double level due to&#xD;
               unicompartmental osteoarthritis (OA).&#xD;
  &#xD;
            -  Comply with all aspects of the treatment, including CT scans, radiographs and 1-year&#xD;
               follow-up&#xD;
  &#xD;
            -  Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Osteotomy for indication of cartilage treatment or other knee surgeries than&#xD;
               unicompartmental OA&#xD;
  &#xD;
            -  Correction using an open wedge above 10 mm&#xD;
  &#xD;
            -  Pregnant women at time of enrollment or women who are planning to become pregnant&#xD;
               during the duration of the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>R.J.H. Custers, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>UMC Utrecht</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>R.J.H. Custers, Dr</last_name>
      <phone>088 7558327</phone>
      <phone_ext>+31</phone_ext>
      <email>r.j.h.custers@umcutrecht.nl</email>
    </overall_contact>
    <location>
      <facility>
        <name>University medical center Utrecht</name>
        <address>
          <city>Utrecht</city>
          <zip>3584 CX</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Roel Custers, M.D., PhD</last_name>
        <phone>0887558327</phone>
        <phone_ext>+31</phone_ext>
        <email>r.j.h.custers@umcutrecht.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <link>
      <url>https://link.springer.com/article/10.1007/s00167-019-05765-z</url>
      <description>Structural allograft impaction enables fast rehabilitation in opening-wedge high tibial osteotomy: a consecutive case series with one year follow-up</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/32459724/</url>
      <description>Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/32080013/</url>
      <description>Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>UMC Utrecht</investigator_affiliation>
      <investigator_full_name>R.J.H. Custers</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>Osteotomy</keyword>
    <keyword>Gap filler</keyword>
    <keyword>Postoperative pain</keyword>
    <keyword>Randomized controlled trial</keyword>
    <keyword>AttraX Putty</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
      <mesh_term>Osteoarthritis, Knee</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05992038
  org study id: 84534
  nct id: NCT05992038
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Rationale: Realignment osteotomies around the knee are a proven surgical treatment for
        unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in
        the early postoperative phase. This is probably due to a combination of bony cut (bone pain)
        and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft
        tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to
        potentially reduce postoperative pain by reducing the bleeding from the bone gap.
  
        Objective: The main aim of this study is to determine whether early postoperative pain is
        decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open
        wedge osteotomy without filling the gap. The secondary aims are faster accelerated
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,
        comparable surgical accuracy, and the occurrence of (serious) adverse events.
  
        Study design: Single-blinded, prospective, randomized controlled trial.
  
        Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double
        level osteotomy.
  
        Intervention: According to a randomization scheme, the osteotomy gap will be filled with
        either the synthetic ceramic material AttraX® Putty or without a gap filler (conventional
        method).
  
        Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS)
        pain during the first week postoperative. The secondary study endpoints are faster
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,
        comparable surgical accuracy, and (serious) adverse events.
  
        Nature and extent of the burden and risks associated with participation, benefit and group
        relatedness: Patients may have the advantage of experiencing less pain postoperatively if
        they are treated with the AttraX® Putty, which can contribute to a faster rehabilitation.
        Risks to the AttraX® Putty group may include an allergic reaction, failure to promote bone
        fusion and excessive bone growth. However, the preclinical studies and clinical studies show
        that the use of AttraX® Putty is safe for use in humans.
  Rationale: Realignment osteotomies around the knee are a proven surgical treatment for
        unicompartmental knee osteoarthritis and a malalignment. Osteotomies can be very painful in
        the early postoperative phase. This is probably due to a combination of bony cut (bone pain)
        and postoperative hematoma (bleeding and leakage of the bone marrow) in the surrounding soft
        tissue. The AttraX® Putty can be used as a gap filler in open wedge osteotomies to
        potentially reduce postoperative pain by reducing the bleeding from the bone gap.
  
        AttraX® Putty: AttraX® putty is a synthetic ceramic which consists of calcium phosphate
        granules and hydroxyapatite (ß-tricalcium phosphate (>90%)/hydroxyapatite(<10%)). It is
        Conformité Européenne (CE) marked as bone void filler and bone haemostasis implant. Unlike
        most other synthetic bone grafts which are only osteoconductive, AttraX Putty is both
        osteoconductive and osteoinductive. Moreover, AttraX® Putty could overcome the disadvantages
        of using autologous bone grafts and allografts, such as, donor site morbidity, increased
        surgical time, and disease transmission. Animal studies and a clinical study showed no
        difference in bone fusion between AttraX® Putty and autograft after instrumented
        thoracolumbar fusion.
  
        Objectives: The main aim of this study is to determine whether early postoperative pain is
        decreased when the osteotomy gap is filled with AttraX® Putty, compared to conventional open
        wedge osteotomy without filling the gap. The secondary aims are faster accelerated
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,
        comparable surgical accuracy, and the occurrence of (serious) adverse events.
  
        Study design: Single-blinded, prospective, randomized controlled trial.
  
        Study population: Adult patients qualifying for open-wedge tibial, open-wedge femur or double
        level osteotomy. A total of 40 patients will be included, 20 patients in the control group
        (without gap filler) and 20 patients in the AttraX Putty group (with AttraX® Putty as gap
        filler). Osteotomy in combinations with cartilage treatment and corrections above 10 mm will
        be excluded.
  
        Main study parameters/endpoints: The main study endpoint is the Numeric Rating Scale (NRS)
        pain during the first week postoperative. The secondary study endpoints are the NRS pain
        during the second week, at 1 months, and at 3 months. Moreover, faster
        rehabilitation/regaining function, reduction of local blood loss, accelerated bone union,
        comparable surgical accuracy, and (serious) adverse events are secondary endpoints.
  
        Study procedures: According to standard care, standing anteroposterior and lateral
        radiographs will be taken postoperatively during hospitalization. The subsequent follow-up
        moments will take place at the outpatient clinic. The follow-up moments take place at +1
        month, +4 months, +6 months, and +1 year postoperatively at the outpatient clinic. The
        follow-up moment of +6 months is extra for this study. During this extra follow-up moment, a
        CT scan of the lower limb (+6 months postoperative) will be performed to be able to draw a
        conclusion about the bone union.
  
        According to standard care, radiographs are performed at +1 day, +1 month, +4 months, and +1
        year. An extra radiograph will be performed at +6 months. Using these radiographs, a
        conclusion can be drawn about the union rate and osteotomy accuracy.
  
        Moreover, the preoperative and postoperative (+1 day) haemoglobin value will be analysed,
        according to standard care. Using the haemoglobin value one of the secondary outcomes can be
        determined (difference in haemoglobin value between preoperative and postoperative).
  
        The rest of the data will be collected at -1 week, +1 day, +1 week, +2 weeks, +3 weeks, +1
        months, + 3 months, +4 months, +6 months, and +1 year postoperatively. This will involve
        questionnaires (Knee Injury and Osteoarthritis Outcome Score (KOOS), EuroQol Five Dimensions
        Health Questionnaire (EQ-5D) and Kujala Patellofemoral Score), the NRS pain score, and
        measuring the calf or upper leg circumference. The calf or upper leg circumference is
        measured at the site where the open wedge osteotomy was performed. For a double-level
        osteotomy, it depends on where the open wedge osteotomy has taken place: the femur or the
        tibia. The location where the calf or upper leg circumference is to be measured will be
        marked with a marker. The patient will be given a tape measure to take home to measure the
        circumference in the morning. Using these data, the primary outcome and secondary outcomes
        can be answered.
  
        If there is an indication for removal of the plate osteosynthesis (for example complaints of
        the plate after one year postoperative), the plate will be surgically removed, and a fine
        needle biopsy will be taken to analyse the newly formed bone. When indicated, the removal of
        the plate osteosynthesis will take place in the period from 12 months to 18 months
        postoperative.
  
        Benefits and risks: Patients have the advantage of being checked more closely during
        follow-up. In addition, patients may have the advantage of experiencing less pain
        postoperatively if they are into the AttraX Putty group, which can contribute to an
        accelerated rehabilitation. Risks to the AttraX Putty group may include an allergic reaction,
        failure to promote bone fusion and excessive bone growth. However, the preclinical studies
        and clinical studies show that the use of AttraX® Putty is safe. Moreover, an extra CT scan
        and radiography are performed during this study. You will receive approximately 0.1
        millisievert (mSv) of additional radiation because of this CT scan. By way of comparison: the
        'ordinary' radiation that everyone in the Netherlands receives anyway is about ~2.9 mSv per
        year.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The mean NRS pain score
  time frame: First week postoperative daily score
  description: Questionnaire to measure pain.The NRS score is a score between 0 and 10, where 0 means no pain and 10 means the most pain imaginable.
  measure: Rehabilitation time
  time frame: After surgery (+2 weeks, +1 months, +3 months, +6 months, +1 year)
  description: Time of rehabilitation period (questionnaires)
  measure: Reduction of local blood loss
  time frame: Before surgery and 1 day after surgery
  description: Amount of blood loss during surgery using haemoglobin measurements
  measure: Reduction of local blood loss
  time frame: Before surgery and a weekly home measurement up to and including 1 month after surgery.
  description: Amount of blood loss during surgery using calf circumference
  measure: Union rate
  time frame: +1 months, +4 months, +6months, and +12 months
  description: Bone union determined on xray and CT-scan
  measure: Postoperative NRS pain score
  time frame: After surgery (second week daily score), +1 months, +3months
  description: Questionnaire to measure pain.The NRS score is a score between 0 and 10, where 0 means no pain and 10 means the most pain imaginable.
  arm group label: Putty
  arm group type: Experimental
  description: The osteotomy gap will be filled with a synthetic ceramic material, Putty
  arm group label: Conventional
  arm group type: Placebo Comparator
  description: Osteotomy performed according to the conventional method, without gap filler
  intervention type: Procedure
  intervention name: Osteotomy with putty
  description: Synthetic ceramic putty
  arm group label: Putty
  intervention type: Procedure
  intervention name: Conventional osteotomy
  description: conventional osteotomy
  arm group label: Conventional
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: R.J.H. Custers, Dr
  role: Principal Investigator
  affiliation: UMC Utrecht
  last name: R.J.H. Custers, Dr
  phone: 088 7558327
  phone ext: +31
  email: r.j.h.custers@umcutrecht.nl
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  url: https://link.springer.com/article/10.1007/s00167-019-05765-z
  description: Structural allograft impaction enables fast rehabilitation in opening-wedge high tibial osteotomy: a consecutive case series with one year follow-up
  url: https://pubmed.ncbi.nlm.nih.gov/32459724/
  description: Increasing Fusion Rate Between 1 and 2 Years After Instrumented Posterolateral Spinal Fusion and the Role of Bone Grafting
  url: https://pubmed.ncbi.nlm.nih.gov/32080013/
  description: Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial
  responsible party type: Principal Investigator
  investigator affiliation: UMC Utrecht
  investigator full name: R.J.H. Custers
  investigator title: Principal investigator
  mesh term: Osteoarthritis
  mesh term: Osteoarthritis, Knee
  sharing ipd: No