<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/NCT03257540</url>
  </required_header>
  <id_info>
    <org_study_id>P30-SP-0001</org_study_id>
    <nct_id>NCT03257540</nct_id>
  </id_info>
  <brief_title>Early Weight-Bearing After Lapidus Arthrodesis</brief_title>
  <official_title>Prospective Clinical Evaluation of Early Weight-Bearing After Lapidus Arthrodesis Using the Phantom™ Intramedullary Nail</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paragon 28</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paragon 28</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this research study is to determine if union rates are affected by early&#xD;
      weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.&#xD;
&#xD;
      The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis&#xD;
      procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing&#xD;
      protocol will be non-inferior to union rates previously published for this procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each subject will undergo a Lapidus Arthrodesis which entails cartilage removal from the 1st&#xD;
      TMT joint, subchondral bone preparation, deformity correction, temporary fixation and&#xD;
      permanent fixation with the Phantom™ Intramedullary Nail. The Phantom™ Intramedullary Nail is&#xD;
      inserted by drilling a hole for the nail at a specified location using instrumentation and a&#xD;
      targeting guide. The nail is inserted into the drill hole and is fixated to the medial&#xD;
      cuneiform and 1st metatarsal using three threaded pegs and a locking screw.&#xD;
&#xD;
      A subchondral drill and chisel are provided in the system with the Lapidus Nail. Subchondral&#xD;
      drilling and feathering of the subchondral bone with a chisel are standard ways to prepare&#xD;
      the subchondral bone and elicit bleeding bone prior to arthrodesis. Use of this&#xD;
      instrumentation is encouraged for this study to ensure that proper bone preparation is&#xD;
      performed for arthrodesis. A torque indicating driver is also encouraged to be used for this&#xD;
      procedure to help guide the surgeon to appropriate compression to apply across the joint.&#xD;
      Alternatively, a standard driver and handle can be used with two-finger tightness when&#xD;
      compressing the joint to achieve a similar effect.&#xD;
&#xD;
      Traditionally, it is common for people who undergo a Lapidus Arthrodesis to be&#xD;
      non-weight-bearing for 6-8 Weeks following the surgical procedure. This time allows the bones&#xD;
      to properly fuse together. During this 6-8 week period, people can be limited in the typical&#xD;
      day-to-day activities they participate in, such as walking, shopping and working.&#xD;
&#xD;
      The Phantom™ Intramedullary Nail may allow subjects to bear weight earlier than traditional&#xD;
      procedures without negatively effecting fusion. By allowing people to bear weight earlier&#xD;
      than traditional methods, it is possible that people will have the opportunity to resume&#xD;
      typical day-to-day activities faster than usual.&#xD;
&#xD;
      The study in question will investigate the Phantom™ Intramedullary Nail with the following&#xD;
      early weight-bearing protocol (see &quot;Post-Operative Protocol for Study Participant&quot; below).&#xD;
&#xD;
      The study preference is that subjects are placed in a splint from 0-2 Weeks. However, a cast&#xD;
      may be substituted according to surgeon preference. No casts are permitted beyond 2 Weeks,&#xD;
      unless deemed as a medical necessity in which case the subject would no longer follow the&#xD;
      early weight-bearing protocol.&#xD;
&#xD;
      The study preference is that subject will be placed in a walking boot at 2 Weeks. However, an&#xD;
      immobilizing shoe may be substituted according to surgeon preference.&#xD;
&#xD;
      Post-Operative Protocol for Study Participant&#xD;
&#xD;
      Activity Level Definitions:&#xD;
&#xD;
      Sedentary: Most activities are done seated or lying down. Surgically repaired foot should be&#xD;
      raised when in seated or reclined position. Standing limited to less than 15 minutes per&#xD;
      hour. Moving is limited to necessary activities such as going to the bathroom or food&#xD;
      preparation.&#xD;
&#xD;
      Light Activity: Standing limited to less than 30 minutes per hour. Movement is mostly limited&#xD;
      to in-home movement such as folding laundry or wiping counters. Short time periods of&#xD;
      movement to leave the house can be performed for necessary activities (such as the grocery&#xD;
      store), but should be limited to less than 30 minutes of standing time.&#xD;
&#xD;
      Moderate Activity: No limits on standing. Walking limited to 45 minute time periods no more&#xD;
      than 3 times per day. No running, jumping or heavy lifting (more than 25 pounds).&#xD;
&#xD;
      Heavy Activity: No limits on walking, running and jumping. No lifting limits.&#xD;
&#xD;
      0-2 Weeks After Surgery:&#xD;
&#xD;
        -  Footwear: You will have a splint (or cast) on your surgically repaired foot/leg. The&#xD;
           splint (or cast) should not be removed. You will wear a comfortable shoe on the other&#xD;
           foot.&#xD;
&#xD;
        -  Weight-Bearing: Do not put any weight on your surgically repaired foot.&#xD;
&#xD;
        -  Mobility Aid: You will use a walking aid such as crutches, rolling knee scooter or&#xD;
           wheelchair to keep all weight off of your surgically repaired foot.&#xD;
&#xD;
        -  Range of Motion Exercises: None.&#xD;
&#xD;
        -  Activity level: Sedentary after surgery working up to light activity over two Weeks&#xD;
           (restarting activities of daily living without putting weight on your foot).&#xD;
&#xD;
      2-6 Weeks After Surgery:&#xD;
&#xD;
        -  Footwear: A restrictive boot (or shoe) will be given to you by your doctor. This should&#xD;
           not be removed other than for range of motion exercises and bathing (seated). Wear a&#xD;
           comfortable shoe on the other foot.&#xD;
&#xD;
        -  Weight-Bearing: Put weight on your foot as you can tolerate in the restrictive boot (or&#xD;
           shoe). Do not walk without the restrictive boot (or shoe).&#xD;
&#xD;
        -  Mobility Aid: If possible, no walking aid should be used. If needed for pain, use a&#xD;
           walking aid as necessary.&#xD;
&#xD;
        -  Range of Motion Exercises: You will do range of motion exercises without the restrictive&#xD;
           boot (or shoe) with no weight on your foot, as instructed by your doctor.&#xD;
&#xD;
        -  Activity level: Light activity with restrictive boot (or shoe). 6 Weeks-3 Months After&#xD;
           Surgery:&#xD;
&#xD;
        -  Footwear: You will wear a restrictive boot (or shoe) working up to supportive shoe&#xD;
           (preferably a lace-up or Velcro shoe including sneakers, running shoes, work boots or&#xD;
           soft leather shoes without a heel) by 8 Weeks after your surgery.&#xD;
&#xD;
        -  Weight-Bearing: Put weight on your foot as you can tolerate. Barefoot walking is not&#xD;
           encouraged.&#xD;
&#xD;
        -  Mobility Aid: No help from crutches, scooter, or wheelchair.&#xD;
&#xD;
        -  Range of Motion Exercises: You will do range of motion exercises as instructed by your&#xD;
           doctor.&#xD;
&#xD;
        -  Activity level: Light activity working up to moderate activity (low impact) as you can&#xD;
           tolerate.&#xD;
&#xD;
      3-6 Months After Surgery:&#xD;
&#xD;
        -  Footwear: At Month 3-4, move from a supportive shoe to footwear of your choice, as you&#xD;
           can tolerate.&#xD;
&#xD;
        -  Weight-Bearing: Put weight on your foot as you can tolerate.&#xD;
&#xD;
        -  Mobility Aid: No help from crutches, scooter, or wheelchair.&#xD;
&#xD;
        -  Activity level: Moderate activity for 3-4 Months post-operative, slowly moving into&#xD;
           heavy activity as you can tolerate after Month 4.&#xD;
&#xD;
           6 Months - 2 Years After Surgery:&#xD;
&#xD;
        -  Footwear: You have no restrictions on footwear.&#xD;
&#xD;
        -  Weight-Bearing: Put weight on your foot as you can tolerate.&#xD;
&#xD;
        -  Mobility Aid: No help from crutches, scooter, or wheelchair.&#xD;
&#xD;
        -  Activity Level: No activity limits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">August 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical/radiographic healing</measure>
    <time_frame>6 months</time_frame>
    <description>Evaluate clinical/radiographic healing (union vs. non-union) after a Lapidus arthrodesis procedure at 6 months following a surgery using the Phantom Intramedullary nail with early weightbearing at 2 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical complications</measure>
    <time_frame>24 Months</time_frame>
    <description>Complications due to the procedure or post-operative protocol or health conditions that could affect other outcome measures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to full weight-bearing</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>The amount of time needed for a participant to become fully weight-bearing after the Lapidus surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in radiographic angular/positional alignment before and after the Lapidus procedure</measure>
    <time_frame>Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months</time_frame>
    <description>Hallux Abductus Angle Intermetatarsal Angle First Metatarsal Declination Angle Distal Metatarsal Articular Angle Sesamoid Position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in VAS Pain Score across multiple time points</measure>
    <time_frame>Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months</time_frame>
    <description>Patient reported pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in AOFAS Forefoot/Hallux Valgus Score across multiple time points</measure>
    <time_frame>Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months</time_frame>
    <description>Clinical score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Mobility Score across multiple time points</measure>
    <time_frame>Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months</time_frame>
    <description>Patient reported mobility assessment, Item Bank v2.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Pain Interference Score across multiple time points</measure>
    <time_frame>Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months</time_frame>
    <description>Patient reported pain interference assessment, Item Bank v1.0, SF 6a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Pain Intensity Score across multiple time points</measure>
    <time_frame>Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months</time_frame>
    <description>Patient reported pain intensity assessment, Item Bank v1.0, SF 3a</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate time to return to work post-operatively while noting labor classification</measure>
    <time_frame>0 to 24 months</time_frame>
    <description>sedentary, light labor, medium labor, heavy labor, very heavy labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate time to return to full duty work post-operatively while noting labor classification</measure>
    <time_frame>0 to 24 months</time_frame>
    <description>sedentary, light labor, medium labor, heavy labor, very heavy labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Range of Motion across multiple time points</measure>
    <time_frame>Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months</time_frame>
    <description>1st MTP Dorsiflexion&#xD;
1st MTP Plantarflexion Ankle Dorsiflexion Ankle Plantarflexion</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Arthrodesis</condition>
  <condition>Bunion</condition>
  <condition>Hallux Valgus</condition>
  <arm_group>
    <arm_group_label>Small Bone Intramedullary Nail</arm_group_label>
    <description>All study participants</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Small Bone Intramedullary Nail</intervention_name>
    <description>Patients undergoing a Lapidus Arthrodesis procedure for hallux valgus correction who are receiving a Phantom Small Bone Intramedullary nail will begin weight-bearing at 2 weeks and follow a pre-determined post-operative protocol.</description>
    <arm_group_label>Small Bone Intramedullary Nail</arm_group_label>
    <other_name>Phantom Small Bone Intramedullary Nail - Lapidus</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of adults age 18 and older with a painful bunion&#xD;
        deformity. The most common age demographic to have surgery for hallux valgus correction is&#xD;
        age 50-59. Additionally, the prevalence of hallux valgus in females is greater than males,&#xD;
        so a higher percentage of female subjects seeking treatment is likely to be expected.&#xD;
&#xD;
        This population is suitable for the purpose of the investigation, as groups most likely to&#xD;
        seek treatment (surgical) for hallux valgus correction will be represented in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is at least 18 years of age with closed physeal plates at the time of&#xD;
             screening.&#xD;
&#xD;
          -  The intermetatarsal angle is greater than or equal to 10 degrees.&#xD;
&#xD;
          -  The hallux valgus angle is greater than or equal to 25 degrees.&#xD;
&#xD;
          -  The subject has foot pain/discomfort on the foot in question.&#xD;
&#xD;
          -  The subject has activity limitations due to the foot in question.&#xD;
&#xD;
          -  The subject agrees to comply with the requirements of the study and complete the study&#xD;
             measures.&#xD;
&#xD;
          -  The subject is willing and able to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject is pregnant.&#xD;
&#xD;
          -  The subject is a current smoker.&#xD;
&#xD;
          -  The subject has been clinically diagnosed with diabetes.&#xD;
&#xD;
          -  The subject has been clinically diagnosed with peripheral neuropathy.&#xD;
&#xD;
          -  The subject had been previously sensitized to titanium.&#xD;
&#xD;
          -  The subject currently takes oral steroids or rheumatoid biologics.&#xD;
&#xD;
          -  The subject has had previous surgery for hallux valgus on operative side.&#xD;
&#xD;
          -  The subject has insufficient quantity or quality of bone to permit stabilization,&#xD;
             conditions that retard healing (not including pathological fractures) and conditions&#xD;
             causing poor blood supply such as peripheral vascular disease.&#xD;
&#xD;
          -  The subject has a history of delayed or non-union for fracture or joint.&#xD;
&#xD;
          -  The subject has an active, suspected or latent infection in the affected area.&#xD;
&#xD;
          -  The subject will require a structural graft in the 1st TMT joint.&#xD;
&#xD;
          -  The subject is scheduled to undergo a concomitant 2nd tarsometatarsal joint&#xD;
             arthrodesis procedure.&#xD;
&#xD;
          -  The subject is scheduled to undergo a same-day bilateral procedure.&#xD;
&#xD;
          -  The subject cannot be scheduled for surgery within 3 months of the pre-operative exam.&#xD;
&#xD;
          -  The subject has previously been enrolled into this study for a contralateral&#xD;
             procedure.&#xD;
&#xD;
          -  The subject is actively involved with a Workman's Compensation case.&#xD;
&#xD;
          -  The subject is not expected to complete the study according to the investigation plan.&#xD;
&#xD;
          -  The subject has been deemed physiologically or psychologically inadequate by the&#xD;
             enrolling physician.&#xD;
&#xD;
          -  The subject is: a prisoner, unable to understand what participation in the study&#xD;
             entails, mentally incompetent, a known abuser of alcohol and/or drugs or anticipated&#xD;
             to be non-compliant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Redwood Orthopaedic Surgery Associates</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopaedic &amp; Spine Center of the Rockies</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Center of Palm Beach County</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bunion</keyword>
  <keyword>early weight-bearing</keyword>
  <keyword>Lapidus</keyword>
  <keyword>arthrodesis</keyword>
  <keyword>intramedullary nail</keyword>
  <keyword>Hallux Valgus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
    <mesh_term>Bunion</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/NCT03257540
org study id: P30-SP-0001
nct id: NCT03257540
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The goal of this research study is to determine if union rates are affected by early
      weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.

      The study hypothesis is that the union rate for those who undergo a Lapidus Arthrodesis
      procedure with the Phantom™ Intramedullary Nail and participate in an early weight-bearing
      protocol will be non-inferior to union rates previously published for this procedure.
Each subject will undergo a Lapidus Arthrodesis which entails cartilage removal from the 1st
      TMT joint, subchondral bone preparation, deformity correction, temporary fixation and
      permanent fixation with the Phantom™ Intramedullary Nail. The Phantom™ Intramedullary Nail is
      inserted by drilling a hole for the nail at a specified location using instrumentation and a
      targeting guide. The nail is inserted into the drill hole and is fixated to the medial
      cuneiform and 1st metatarsal using three threaded pegs and a locking screw.

      A subchondral drill and chisel are provided in the system with the Lapidus Nail. Subchondral
      drilling and feathering of the subchondral bone with a chisel are standard ways to prepare
      the subchondral bone and elicit bleeding bone prior to arthrodesis. Use of this
      instrumentation is encouraged for this study to ensure that proper bone preparation is
      performed for arthrodesis. A torque indicating driver is also encouraged to be used for this
      procedure to help guide the surgeon to appropriate compression to apply across the joint.
      Alternatively, a standard driver and handle can be used with two-finger tightness when
      compressing the joint to achieve a similar effect.

      Traditionally, it is common for people who undergo a Lapidus Arthrodesis to be
      non-weight-bearing for 6-8 Weeks following the surgical procedure. This time allows the bones
      to properly fuse together. During this 6-8 week period, people can be limited in the typical
      day-to-day activities they participate in, such as walking, shopping and working.

      The Phantom™ Intramedullary Nail may allow subjects to bear weight earlier than traditional
      procedures without negatively effecting fusion. By allowing people to bear weight earlier
      than traditional methods, it is possible that people will have the opportunity to resume
      typical day-to-day activities faster than usual.

      The study in question will investigate the Phantom™ Intramedullary Nail with the following
      early weight-bearing protocol (see "Post-Operative Protocol for Study Participant" below).

      The study preference is that subjects are placed in a splint from 0-2 Weeks. However, a cast
      may be substituted according to surgeon preference. No casts are permitted beyond 2 Weeks,
      unless deemed as a medical necessity in which case the subject would no longer follow the
      early weight-bearing protocol.

      The study preference is that subject will be placed in a walking boot at 2 Weeks. However, an
      immobilizing shoe may be substituted according to surgeon preference.

      Post-Operative Protocol for Study Participant

      Activity Level Definitions:

      Sedentary: Most activities are done seated or lying down. Surgically repaired foot should be
      raised when in seated or reclined position. Standing limited to less than 15 minutes per
      hour. Moving is limited to necessary activities such as going to the bathroom or food
      preparation.

      Light Activity: Standing limited to less than 30 minutes per hour. Movement is mostly limited
      to in-home movement such as folding laundry or wiping counters. Short time periods of
      movement to leave the house can be performed for necessary activities (such as the grocery
      store), but should be limited to less than 30 minutes of standing time.

      Moderate Activity: No limits on standing. Walking limited to 45 minute time periods no more
      than 3 times per day. No running, jumping or heavy lifting (more than 25 pounds).

      Heavy Activity: No limits on walking, running and jumping. No lifting limits.

      0-2 Weeks After Surgery:

        -  Footwear: You will have a splint (or cast) on your surgically repaired foot/leg. The
           splint (or cast) should not be removed. You will wear a comfortable shoe on the other
           foot.

        -  Weight-Bearing: Do not put any weight on your surgically repaired foot.

        -  Mobility Aid: You will use a walking aid such as crutches, rolling knee scooter or
           wheelchair to keep all weight off of your surgically repaired foot.

        -  Range of Motion Exercises: None.

        -  Activity level: Sedentary after surgery working up to light activity over two Weeks
           (restarting activities of daily living without putting weight on your foot).

      2-6 Weeks After Surgery:

        -  Footwear: A restrictive boot (or shoe) will be given to you by your doctor. This should
           not be removed other than for range of motion exercises and bathing (seated). Wear a
           comfortable shoe on the other foot.

        -  Weight-Bearing: Put weight on your foot as you can tolerate in the restrictive boot (or
           shoe). Do not walk without the restrictive boot (or shoe).

        -  Mobility Aid: If possible, no walking aid should be used. If needed for pain, use a
           walking aid as necessary.

        -  Range of Motion Exercises: You will do range of motion exercises without the restrictive
           boot (or shoe) with no weight on your foot, as instructed by your doctor.

        -  Activity level: Light activity with restrictive boot (or shoe). 6 Weeks-3 Months After
           Surgery:

        -  Footwear: You will wear a restrictive boot (or shoe) working up to supportive shoe
           (preferably a lace-up or Velcro shoe including sneakers, running shoes, work boots or
           soft leather shoes without a heel) by 8 Weeks after your surgery.

        -  Weight-Bearing: Put weight on your foot as you can tolerate. Barefoot walking is not
           encouraged.

        -  Mobility Aid: No help from crutches, scooter, or wheelchair.

        -  Range of Motion Exercises: You will do range of motion exercises as instructed by your
           doctor.

        -  Activity level: Light activity working up to moderate activity (low impact) as you can
           tolerate.

      3-6 Months After Surgery:

        -  Footwear: At Month 3-4, move from a supportive shoe to footwear of your choice, as you
           can tolerate.

        -  Weight-Bearing: Put weight on your foot as you can tolerate.

        -  Mobility Aid: No help from crutches, scooter, or wheelchair.

        -  Activity level: Moderate activity for 3-4 Months post-operative, slowly moving into
           heavy activity as you can tolerate after Month 4.

           6 Months - 2 Years After Surgery:

        -  Footwear: You have no restrictions on footwear.

        -  Weight-Bearing: Put weight on your foot as you can tolerate.

        -  Mobility Aid: No help from crutches, scooter, or wheelchair.

        -  Activity Level: No activity limits.
observational model: Case-Only
time perspective: Prospective
measure: Clinical/radiographic healing
time frame: 6 months
description: Evaluate clinical/radiographic healing (union vs. non-union) after a Lapidus arthrodesis procedure at 6 months following a surgery using the Phantom Intramedullary nail with early weightbearing at 2 weeks.
measure: Clinical complications
time frame: 24 Months
description: Complications due to the procedure or post-operative protocol or health conditions that could affect other outcome measures
measure: Time to full weight-bearing
time frame: 0 to 12 months
description: The amount of time needed for a participant to become fully weight-bearing after the Lapidus surgery.
measure: Change in radiographic angular/positional alignment before and after the Lapidus procedure
time frame: Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months
description: Hallux Abductus Angle Intermetatarsal Angle First Metatarsal Declination Angle Distal Metatarsal Articular Angle Sesamoid Position
measure: Change in VAS Pain Score across multiple time points
time frame: Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months
description: Patient reported pain
measure: Change in AOFAS Forefoot/Hallux Valgus Score across multiple time points
time frame: Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months
description: Clinical score
measure: Change in PROMIS Mobility Score across multiple time points
time frame: Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months
description: Patient reported mobility assessment, Item Bank v2.0
measure: Change in PROMIS Pain Interference Score across multiple time points
time frame: Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months
description: Patient reported pain interference assessment, Item Bank v1.0, SF 6a
measure: Change in PROMIS Pain Intensity Score across multiple time points
time frame: Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months
description: Patient reported pain intensity assessment, Item Bank v1.0, SF 3a
measure: Evaluate time to return to work post-operatively while noting labor classification
time frame: 0 to 24 months
description: sedentary, light labor, medium labor, heavy labor, very heavy labor
measure: Evaluate time to return to full duty work post-operatively while noting labor classification
time frame: 0 to 24 months
description: sedentary, light labor, medium labor, heavy labor, very heavy labor
measure: Change in Range of Motion across multiple time points
time frame: Pre-operatively, 2 Weeks, 6 Weeks, 12 Weeks, 6 Months, 12 Months, 24 Months
description: 1st MTP Dorsiflexion
1st MTP Plantarflexion Ankle Dorsiflexion Ankle Plantarflexion
arm group label: Small Bone Intramedullary Nail
description: All study participants
intervention type: Device
intervention name: Small Bone Intramedullary Nail
description: Patients undergoing a Lapidus Arthrodesis procedure for hallux valgus correction who are receiving a Phantom Small Bone Intramedullary nail will begin weight-bearing at 2 weeks and follow a pre-determined post-operative protocol.
arm group label: Small Bone Intramedullary Nail
other name: Phantom Small Bone Intramedullary Nail - Lapidus
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hallux Valgus
mesh term: Bunion
sharing ipd: No