<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/NCT03768622</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00933; ch18Saxer2</org_study_id>
    <nct_id>NCT03768622</nct_id>
  </id_info>
  <brief_title>Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome</brief_title>
  <acronym>ProFi</acronym>
  <official_title>Proximal Femoral Fractures - Patient Population, Risk Factors, Surgical Performance and Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Proximal femoral fractures are a typical pathology in elderly patients after a low-energy&#xD;
      trauma.&#xD;
&#xD;
      This study analyses preexisting risk factors for proximal femoral fractures as well as for&#xD;
      failing to reach the previous functional level, difference in outcome between patients with&#xD;
      femoral neck fracture compared to those with pertrochanteric fracture, surgical performance&#xD;
      and its significance for the functional outcome, as well as the impact of proximal femoral&#xD;
      fractures on patients' one-year independence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">March 6, 2021</completion_date>
  <primary_completion_date type="Actual">March 6, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>from date of surgery until 1 year follow up period after surgery</time_frame>
    <description>Quantification of Rehospitalizations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>at 1 year follow up date after surgery</time_frame>
    <description>Change in living situation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)</time_frame>
    <description>Quantification of major complications with documentation of affected organ System, intensive care Treatment, Discharge where to (home, home with support, in-patient rehabilitation, nursing home), length of hospital stay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>from date of surgery until 1 year follow up period after surgery</time_frame>
    <description>Quantification of Reoperations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>from date of surgery until 1 year follow up period after surgery</time_frame>
    <description>Quantification of infections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>from date of surgery until 1 year follow up period after surgery</time_frame>
    <description>Quantification of deaths and date of death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>at 1 year follow up date after surgery</time_frame>
    <description>Change in use of walking aids</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>at 1 year follow up date after surgery</time_frame>
    <description>Change in pain at rest (yes/no),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>at 1 year follow up date after surgery</time_frame>
    <description>Change in pain under stress (yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>at 1 year follow up date after surgery</time_frame>
    <description>Change in restrictions in daily living (yes/no),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>at 1 year follow up date after surgery</time_frame>
    <description>Change in use of analgetics (yes/no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)</time_frame>
    <description>Quantification of intensive care Treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)</time_frame>
    <description>Quantification of Discharge where to (home, home with support, in-patient rehabilitation, nursing home)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient clinical outcome</measure>
    <time_frame>during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)</time_frame>
    <description>Quantification of length of hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in patient clinical outcome (according Penrod score)</measure>
    <time_frame>preoperatively and at 1 year follow up date after surgery</time_frame>
    <description>Penrod score reflects the patients' preoperative functional level and living. Patients are classified concerning their prefracture age (1: &lt;75 years, 2: 75-84 years, 3 ≥85 years, their ability in performing activities of daily life (ADL) as well as their cognitive status (dementia in clusters 2B and 3D Situation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures</measure>
    <time_frame>day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>central positioning and insertion of the neck screw</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiological outcome: assessment of surgical treatment of femoral neck fractures</measure>
    <time_frame>1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>development of periacetabular ossification according to Brooker&#xD;
A islands of bone within the soft tissues about the hip&#xD;
B bone spurs originating from the pelvis or proximal end of the femur, leaving at least 1 cm between opposing bone surfaces&#xD;
C bone spurs originating from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm&#xD;
D bone ankylosis of the hip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures)</measure>
    <time_frame>1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>differences in the distance between perpendicular lines drawn to the bisecting axis of the medullary canal, at the top of the femoral head and at the tip of the great trochanter in mm</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiological outcome: assessment of surgical treatment of femoral neck fractures</measure>
    <time_frame>1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>cortical atrophy i.e. longitudinal intracortical porosis with a consecutive thinning of the cortex without measurable thickening of the femur (yes-no-n.a.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiological outcome: assessment of surgical treatment of femoral neck fractures</measure>
    <time_frame>1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>osteolysis i.e. progressive, newly developed endosteal bone loss with a diameter &gt; 3 mm, either with scalloping or a bead-shaped lucency at the cement-bone interface</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiological outcome: assessment of surgical treatment of femoral neck fractures</measure>
    <time_frame>1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>debonding i.e. radiolucent line at the prosthesis-cement interface not visible on the first postoperative radiograph (yes-no-n.a.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures</measure>
    <time_frame>day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>leg-length discrepancy (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in radiological outcome: assessment of surgical treatment of femoral neck fractures</measure>
    <time_frame>day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>leg-length discrepancy in mm (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in radiological outcome: assessment of surgical treatment of femoral neck fractures</measure>
    <time_frame>day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)</time_frame>
    <description>alignment on ap view (central axis of the distal stem to bisecting axis of medullary canal at the isthmus) in °</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2906</enrollment>
  <condition>Proximal Femoral Fracture</condition>
  <arm_group>
    <arm_group_label>surgery for femoral neck fracture</arm_group_label>
    <description>patients with proximal femoral fracture (type: femoral neck fracture) with surgical procedure: partial hip arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>surgery for pertrochanteric femoral fractures</arm_group_label>
    <description>patients with proximal femoral fracture (type:pertrochanteric femoral fractures) with surgical procedure: intramedullary nail type Gamma® Nail or similar</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery for pertrochanteric femoral fracture</intervention_name>
    <description>surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures</description>
    <arm_group_label>surgery for pertrochanteric femoral fractures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>surgery for femoral neck fracture</intervention_name>
    <description>surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures</description>
    <arm_group_label>surgery for femoral neck fracture</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated for a proximal femoral fracture at the University Hospital Basel between&#xD;
        01.08.2009 and 31.07.2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  surgery with intramedullary nail type Gamma® Nail or similar in case of&#xD;
             pertrochanteric fractures or&#xD;
&#xD;
          -  with a partial hip arthroplasty in case of femoral neck fractures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical follow up at another institution&#xD;
&#xD;
          -  Documented dissent in study participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Franziska Saxer, Dr. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedics and Trauma Surgery (DOTS).</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopaedics and Trauma Surgery (DOTS).</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>October 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>November 3, 2021</last_update_submitted>
  <last_update_submitted_qc>November 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>femoral neck fracture</keyword>
  <keyword>pertrochanteric femoral fracture</keyword>
  <keyword>risk factor for proximal femoral fracture</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>
  </condition_browse>
  <!-- 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/NCT03768622
org study id: 2018-00933; ch18Saxer2
nct id: NCT03768622
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Proximal femoral fractures are a typical pathology in elderly patients after a low-energy
      trauma.

      This study analyses preexisting risk factors for proximal femoral fractures as well as for
      failing to reach the previous functional level, difference in outcome between patients with
      femoral neck fracture compared to those with pertrochanteric fracture, surgical performance
      and its significance for the functional outcome, as well as the impact of proximal femoral
      fractures on patients' one-year independence.
observational model: Cohort
time perspective: Retrospective
measure: Change in Patient clinical outcome
time frame: from date of surgery until 1 year follow up period after surgery
description: Quantification of Rehospitalizations
measure: Change in Patient clinical outcome
time frame: at 1 year follow up date after surgery
description: Change in living situation
measure: Change in Patient clinical outcome
time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
description: Quantification of major complications with documentation of affected organ System, intensive care Treatment, Discharge where to (home, home with support, in-patient rehabilitation, nursing home), length of hospital stay
measure: Change in Patient clinical outcome
time frame: from date of surgery until 1 year follow up period after surgery
description: Quantification of Reoperations
measure: Change in Patient clinical outcome
time frame: from date of surgery until 1 year follow up period after surgery
description: Quantification of infections
measure: Change in Patient clinical outcome
time frame: from date of surgery until 1 year follow up period after surgery
description: Quantification of deaths and date of death
measure: Change in Patient clinical outcome
time frame: at 1 year follow up date after surgery
description: Change in use of walking aids
measure: Change in Patient clinical outcome
time frame: at 1 year follow up date after surgery
description: Change in pain at rest (yes/no),
measure: Change in Patient clinical outcome
time frame: at 1 year follow up date after surgery
description: Change in pain under stress (yes/no)
measure: Change in Patient clinical outcome
time frame: at 1 year follow up date after surgery
description: Change in restrictions in daily living (yes/no),
measure: Change in Patient clinical outcome
time frame: at 1 year follow up date after surgery
description: Change in use of analgetics (yes/no)
measure: Change in Patient clinical outcome
time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
description: Quantification of intensive care Treatment
measure: Change in Patient clinical outcome
time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
description: Quantification of Discharge where to (home, home with support, in-patient rehabilitation, nursing home)
measure: Change in Patient clinical outcome
time frame: during hospitalization (from date of surgery until discharge date after surgery (approx. 1-3 weeks)
description: Quantification of length of hospital stay
measure: Change in patient clinical outcome (according Penrod score)
time frame: preoperatively and at 1 year follow up date after surgery
description: Penrod score reflects the patients' preoperative functional level and living. Patients are classified concerning their prefracture age (1: <75 years, 2: 75-84 years, 3 ≥85 years, their ability in performing activities of daily life (ADL) as well as their cognitive status (dementia in clusters 2B and 3D Situation)
measure: Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
description: central positioning and insertion of the neck screw
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
time frame: 1year postoperative (if n.a. min 6 months postoperative)
description: development of periacetabular ossification according to Brooker
A islands of bone within the soft tissues about the hip
B bone spurs originating from the pelvis or proximal end of the femur, leaving at least 1 cm between opposing bone surfaces
C bone spurs originating from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm
D bone ankylosis of the hip
measure: Change in subsidence (radiological outcome: assessment of surgical treatment of femoral neck fractures)
time frame: 1year postoperative (if n.a. min 6 months postoperative)
description: differences in the distance between perpendicular lines drawn to the bisecting axis of the medullary canal, at the top of the femoral head and at the tip of the great trochanter in mm
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
time frame: 1year postoperative (if n.a. min 6 months postoperative)
description: cortical atrophy i.e. longitudinal intracortical porosis with a consecutive thinning of the cortex without measurable thickening of the femur (yes-no-n.a.)
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
time frame: 1year postoperative (if n.a. min 6 months postoperative)
description: osteolysis i.e. progressive, newly developed endosteal bone loss with a diameter > 3 mm, either with scalloping or a bead-shaped lucency at the cement-bone interface
measure: radiological outcome: assessment of surgical treatment of femoral neck fractures
time frame: 1year postoperative (if n.a. min 6 months postoperative)
description: debonding i.e. radiolucent line at the prosthesis-cement interface not visible on the first postoperative radiograph (yes-no-n.a.)
measure: Change in radiological outcome: assessment of surgical treatment of pertrochanteric fractures
time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
description: leg-length discrepancy (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)
measure: Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
description: leg-length discrepancy in mm (tangent to inferior pubic rami and tip of greater trochanter, if n.a. insertion of lesser trochanter)
measure: Change in radiological outcome: assessment of surgical treatment of femoral neck fractures
time frame: day of surgical intervention (immediately after surgery) and 1year postoperative (if n.a. min 6 months postoperative)
description: alignment on ap view (central axis of the distal stem to bisecting axis of medullary canal at the isthmus) in °
arm group label: surgery for femoral neck fracture
description: patients with proximal femoral fracture (type: femoral neck fracture) with surgical procedure: partial hip arthroplasty
arm group label: surgery for pertrochanteric femoral fractures
description: patients with proximal femoral fracture (type:pertrochanteric femoral fractures) with surgical procedure: intramedullary nail type Gamma® Nail or similar
intervention type: Procedure
intervention name: surgery for pertrochanteric femoral fracture
description: surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures
arm group label: surgery for pertrochanteric femoral fractures
intervention type: Procedure
intervention name: surgery for femoral neck fracture
description: surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures
arm group label: surgery for femoral neck fracture
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Franziska Saxer, Dr. MD
role: Principal Investigator
affiliation: Department of Orthopaedics and Trauma Surgery (DOTS).
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures