<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/NCT04473196</url>
  </required_header>
  <id_info>
    <org_study_id>PTC 2020-01</org_study_id>
    <nct_id>NCT04473196</nct_id>
  </id_info>
  <brief_title>The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion</brief_title>
  <official_title>Prospective, Randomized Trial to Evaluate the Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nova Scotia Health Authority</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      randomized-controlled trial looking specifically at the effect of weight bearing on the&#xD;
      outcomes of first MTP joint fusions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this prospective, randomized controlled trial is to determine if there are&#xD;
      any adverse outcomes associated with immediate weight bearing as compared to non-weight&#xD;
      bearing following first MTP joint fusion. The primary outcome measures will look at patient&#xD;
      reported outcomes of pain and function. The secondary outcome measures will be the difference&#xD;
      in the incidence of non-union, as well as adverse events/complications (malunion, wound&#xD;
      complications, hardware complications, infection, stress fracture).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 30, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Foot and Ankle Ability Measure (FAAM)</measure>
    <time_frame>pre op</time_frame>
    <description>Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Foot and Ankle Ability Measure (FAAM)</measure>
    <time_frame>6 months</time_frame>
    <description>Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analogue scale(VAS)</measure>
    <time_frame>pre op</time_frame>
    <description>patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analogue scale(VAS)</measure>
    <time_frame>12 weeks</time_frame>
    <description>patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic healing</measure>
    <time_frame>6 weeks</time_frame>
    <description>Union is defined as new bone formation across the cortex of the fusion site</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Hallux Valgus</condition>
  <condition>Hallux Rigidus</condition>
  <arm_group>
    <arm_group_label>Weightbearing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Immediate weightbearing after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non weightbearing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nonweightbearing x 6 weeks post surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>weightbearing</intervention_name>
    <description>immediate weightbearing</description>
    <arm_group_label>Non weightbearing</arm_group_label>
    <arm_group_label>Weightbearing</arm_group_label>
    <other_name>nonweightbearing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or great&#xD;
&#xD;
          -  Medically fit for surgery&#xD;
&#xD;
          -  Patients diagnosed with condition for which a 1st MTP joint fusion is a surgical&#xD;
             management option based on clinical examination and radiographs&#xD;
&#xD;
          -  Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wear&#xD;
             modification)&#xD;
&#xD;
          -  Surgery is for an isolated 1st MTP fusion&#xD;
&#xD;
          -  Able and willing to comply with follow up schedule and requirements&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years old&#xD;
&#xD;
          -  Surgical booking is for more than just 1st MTP fusion&#xD;
&#xD;
          -  Unable to comply with follow up schedule and requirements&#xD;
&#xD;
          -  Unable to provide informed consent&#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>Mark Glazebrook, MD FRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>NSHA\ Dalhousie UNiversity</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patricia Francis, RN</last_name>
    <phone>9022250199</phone>
    <email>francisp@nshealth.ca</email>
  </overall_contact>
  <reference>
    <citation>Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How? Foot Ankle Clin. 2015 Sep;20(3):465-77. doi: 10.1016/j.fcl.2015.04.008. Epub 2015 Jun 10.</citation>
    <PMID>26320560</PMID>
  </reference>
  <reference>
    <citation>Wood EV, Walker CR, Hennessy MS. First metatarsophalangeal arthrodesis for hallux valgus. Foot Ankle Clin. 2014 Jun;19(2):245-58. doi: 10.1016/j.fcl.2014.02.006. Epub 2014 Mar 21.</citation>
    <PMID>24878413</PMID>
  </reference>
  <reference>
    <citation>Little JB. First metatarsophalangeal joint arthrodesis in the treatment of hallux valgus. Clin Podiatr Med Surg. 2014 Apr;31(2):281-9. doi: 10.1016/j.cpm.2013.12.009. Epub 2014 Feb 26.</citation>
    <PMID>24685193</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Mark Glazebrook</investigator_full_name>
    <investigator_title>MSc, PhD, Dip Sports Med., MD, F.R.C.S. (C) Professor of Surgery Dalhousie University</investigator_title>
  </responsible_party>
  <keyword>MTP Hallux rigidus Osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
    <mesh_term>Hallux Rigidus</mesh_term>
    <mesh_term>Hallux Limitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04473196
org study id: PTC 2020-01
nct id: NCT04473196
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
randomized-controlled trial looking specifically at the effect of weight bearing on the
      outcomes of first MTP joint fusions
The objective of this prospective, randomized controlled trial is to determine if there are
      any adverse outcomes associated with immediate weight bearing as compared to non-weight
      bearing following first MTP joint fusion. The primary outcome measures will look at patient
      reported outcomes of pain and function. The secondary outcome measures will be the difference
      in the incidence of non-union, as well as adverse events/complications (malunion, wound
      complications, hardware complications, infection, stress fracture).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Foot and Ankle Ability Measure (FAAM)
time frame: pre op
description: Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
measure: Foot and Ankle Ability Measure (FAAM)
time frame: 6 months
description: Activities of Daily Living (ADL) Scored out of 100\higher score indicates more function
measure: Visual analogue scale(VAS)
time frame: pre op
description: patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
measure: Visual analogue scale(VAS)
time frame: 12 weeks
description: patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
measure: Radiographic healing
time frame: 6 weeks
description: Union is defined as new bone formation across the cortex of the fusion site
arm group label: Weightbearing
arm group type: Active Comparator
description: Immediate weightbearing after surgery
arm group label: Non weightbearing
arm group type: Active Comparator
description: nonweightbearing x 6 weeks post surgery
intervention type: Other
intervention name: weightbearing
description: immediate weightbearing
arm group label: Non weightbearing
arm group label: Weightbearing
other name: nonweightbearing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Glazebrook, MD FRCS
role: Principal Investigator
affiliation: NSHA\ Dalhousie UNiversity
last name: Patricia Francis, RN
phone: 9022250199
email: francisp@nshealth.ca
citation: Rammelt S, Panzner I, Mittlmeier T. Metatarsophalangeal Joint Fusion: Why and How? Foot Ankle Clin. 2015 Sep;20(3):465-77. doi: 10.1016/j.fcl.2015.04.008. Epub 2015 Jun 10.
PMID: 26320560
citation: Wood EV, Walker CR, Hennessy MS. First metatarsophalangeal arthrodesis for hallux valgus. Foot Ankle Clin. 2014 Jun;19(2):245-58. doi: 10.1016/j.fcl.2014.02.006. Epub 2014 Mar 21.
PMID: 24878413
citation: Little JB. First metatarsophalangeal joint arthrodesis in the treatment of hallux valgus. Clin Podiatr Med Surg. 2014 Apr;31(2):281-9. doi: 10.1016/j.cpm.2013.12.009. Epub 2014 Feb 26.
PMID: 24685193
responsible party type: Principal Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Mark Glazebrook
investigator title: MSc, PhD, Dip Sports Med., MD, F.R.C.S. (C) Professor of Surgery Dalhousie University
mesh term: Hallux Valgus
mesh term: Hallux Rigidus
mesh term: Hallux Limitus
sharing ipd: No