<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/NCT03032653</url>
  </required_header>
  <id_info>
    <org_study_id>FHREB #: 2016-101</org_study_id>
    <nct_id>NCT03032653</nct_id>
  </id_info>
  <brief_title>Immediate Weight-Bearing Ankle Study</brief_title>
  <official_title>Immediate Unprotected Weight-Bearing and Range of Motion After Open Reduction and Internal Fixation of Unstable Ankle Fractures. A Historical Control Group Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fraser Orthopaedic Research Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fraser Orthopaedic Research Society</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>
      This single-centre historical control group comparative study will compare outcomes of&#xD;
      surgically-treated rotational ankle fractures and the current routine practice of early&#xD;
      protected weightbearing and range of motion with immediate unprotected weightbearing as&#xD;
      tolerated and range of motion after ankle open reduction and internal fixation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ankle fractures are among the most common injuries, making up 9% of all fractures. Rotational&#xD;
      ankle fractures are among the most common of all fractures, with an incidence averaging 4.2&#xD;
      per 1,000 individuals annually. These fractures range from minimal injuries amenable to&#xD;
      non-surgical management to complex injuries with potential of long-term sequelae. Known risk&#xD;
      factors for ankle fractures are age, body mass index and previous ankle fracture, with the&#xD;
      highest incidence in elderly women.&#xD;
&#xD;
      Most ankle fractures are low-energy injuries which occur when the body rotates about a&#xD;
      planted foot, whether it be during sports, normal gait, or otherwise. Stable ankle fractures&#xD;
      are generally treated non-surgically, while unstable fractures are usually treated with&#xD;
      surgical reduction and fixation, with indications previously well-described and published.&#xD;
&#xD;
      However, the post-operative management of such injuries is still controversial, with large&#xD;
      variability between care providers. Protocols range from complete immobilization of the&#xD;
      affected ankle and non-weightbearing to early range-of-motion (ROM) and weightbearing (WB).&#xD;
      Studies have compared immobilization and non-WB to early ROM and WB but results have been&#xD;
      mixed, with the most recent study demonstrating safety and advantages to protected WB and ROM&#xD;
      at two weeks post-operatively versus non-WB and immobilization for six weeks.&#xD;
&#xD;
      The Investigators intend to expand on the studies above and propose a single-centre&#xD;
      historical control group comparative study to compare outcomes of surgically-treated&#xD;
      rotational ankle fractures and the current routine practice of early protected weightbearing&#xD;
      and range of motion with immediate unprotected weightbearing as tolerated and range of motion&#xD;
      after ankle open reduction and internal fixation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 9, 2017</start_date>
  <completion_date type="Actual">January 18, 2021</completion_date>
  <primary_completion_date type="Actual">January 18, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Olerud and Molander Score</measure>
    <time_frame>6 weeks post treatment</time_frame>
    <description>An assessment of symptoms after ankle fracture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ-5D</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>A questionnaire pertaining to the effect of the participant's ankle fracture on their ability to work and perform regular activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>Amount of ankle dorsiflexion and plantarflexion (measured in degrees) as determined by goniometer assessment, as well as total arc of ankle ROM (dorsiflexion+ plantarflexion). This will be measured on both ankles for comparison.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound Healing</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>Complications regarding the surgical wound, including but not limited to signs of infection or dehiscence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fracture Healing</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>Radiographic assessment to determine healing, loss of reduction, loss of hardware fixation, or ankle alignment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for Re-operation</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>Any issue, whether it be a wound complication or fracture complication, requiring re-operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Return to Work</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>The chronological time between the date of surgery to the first day the participant returned to occupational duties, if currently employed and returns to work within the 12 weeks postoperative follow-up period. For the purposes of this study, students enrolled in educational activities will have their schooling treated as their occupational duty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic assessment</measure>
    <time_frame>2, 6 and 12 weeks post treatment</time_frame>
    <description>Assessment of alignment, hardware fixation, fracture reduction and loss of reduction (defined as any shft of 2mm or more in fracture position)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Ankle Fractures</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Late WB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Patients receive a plaster splint in the operating room. They are not permitted to WB or ROM on the affected limb at this stage. At the first follow-up appointment (two weeks post-op), the splint is removed and a removable pre-fabricated walking boot applied. At this stage the patient is permitted to WB as tolerated while wearing the boot, and to perform ROM exercises with the boot removed. At six weeks post-op, the boot is discontinued and full unrestricted and unprotected weightbearing and ROM is permitted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate unprotected WB and ROM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient do NOT receive a brace or splint of any kind. They are permitted to weightbear and range of motion as tolerated within the limitations of their own comfort. Use of ambulatory aids of any kind is permitted as needed without restrictions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Late Rehabilitation</intervention_name>
    <description>Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot.&#xD;
6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:</description>
    <arm_group_label>Late WB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early Rehabilitation</intervention_name>
    <description>Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted</description>
    <arm_group_label>Immediate unprotected WB and ROM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  lateral malleolus fracture with talar shaft&#xD;
&#xD;
          -  vertical shear medial malleolus fracture without superior articular involvement&#xD;
&#xD;
          -  bimalleolar fracture&#xD;
&#xD;
          -  any ankle fracture with posterior malleolus fragment involving 25% or less of the&#xD;
             articular surface on the lateral ankle radiograph&#xD;
&#xD;
          -  43.B1 (pure split of distal tibia - but only if does not involve any of tibial&#xD;
             plafond, i.e., only the vertical split of medial malleolus)&#xD;
&#xD;
          -  44.A1 (Weber A)&#xD;
&#xD;
          -  44.A2 (Bimalleolar)&#xD;
&#xD;
          -  44.A3 (posterior malleolus involvement - but only if &lt; 25% articular involvement on&#xD;
             lateral x-ray)&#xD;
&#xD;
          -  44-B1 (Isolated)&#xD;
&#xD;
          -  44.B2 (with medial lesion)&#xD;
&#xD;
          -  44.B3 (with medial lesion &amp; Volkmann's #)&#xD;
&#xD;
          -  closed, Gustilo-Anderson Grade I or Grade II open fractures are included&#xD;
&#xD;
          -  willing and able to sign the consent&#xD;
&#xD;
          -  willing and able to follow the protocol and attend follow-up visits&#xD;
&#xD;
          -  able to read and understand English or have an interpreter available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  skeletal immaturity demonstrated radiographically by open physes&#xD;
&#xD;
          -  previous ipsilateral ankle surgery&#xD;
&#xD;
          -  bilateral ankle fractures&#xD;
&#xD;
          -  non ambulatory prior to injury&#xD;
&#xD;
          -  inability to comply with postoperative protocol (i.e., cognitive impairment)&#xD;
&#xD;
          -  medical comorbidity precluding surgery&#xD;
&#xD;
          -  poorly controlled diabetes (i.e. dense neuropathy / hx of ulcers / sensory deficit)&#xD;
&#xD;
          -  polytrauma patients (other injuries involving the ipsi/contralateral lower limbs,&#xD;
             including the hip, that would interfere with mobilization/rehabilitation)&#xD;
&#xD;
          -  surgical date &gt; 14 days (time of injury to OR)&#xD;
&#xD;
          -  Gustilo-Anderson grade III open fractures&#xD;
&#xD;
          -  tibial plafond fractures&#xD;
&#xD;
          -  active infection at the surgical site diagnosed clinically by the attending surgeon&#xD;
&#xD;
          -  any ankle fracture with posterior malleolus fragment involving more than 25% of the&#xD;
             articular surface on the lateral ankle radiograph&#xD;
&#xD;
          -  any medial malleolus fracture involving the superior articular surface&#xD;
&#xD;
          -  any ankle fracture requiring syndesmosis fixation&#xD;
&#xD;
          -  any ankle fracture-dislocation&#xD;
&#xD;
          -  incarceration&#xD;
&#xD;
          -  likely problems, in the judgment of the investigator, with maintaining follow-up&#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>Darius G Viskontas, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Columbian Hospital / Fraser Health Authority</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vu (Brian) Le, MD, FRSCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Columbian Hospital / Fraser Health Authority</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kelly L Apostle, MD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Columbian Hospital / Fraser Health Authority</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Columbian Hospital / Fraser Health Authority</name>
      <address>
        <city>New Westminster</city>
        <state>British Columbia</state>
        <zip>V3L 3M2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.</citation>
    <PMID>16814787</PMID>
  </reference>
  <reference>
    <citation>Hoelsbrekken SE, Kaul-Jensen K, Morch T, Vika H, Clementsen T, Paulsrud O, Petursson G, Stiris M, Stromsoe K. Nonoperative treatment of the medial malleolus in bimalleolar and trimalleolar ankle fractures: a randomized controlled trial. J Orthop Trauma. 2013 Nov;27(11):633-7. doi: 10.1097/BOT.0b013e31828e1bb7.</citation>
    <PMID>23454858</PMID>
  </reference>
  <reference>
    <citation>Petrisor BA, Poolman R, Koval K, Tornetta P 3rd, Bhandari M; Evidence-Based Orthopaedic Trauma Working Group. Management of displaced ankle fractures. J Orthop Trauma. 2006 Jul;20(7):515-8. doi: 10.1097/00005131-200608000-00012.</citation>
    <PMID>16891946</PMID>
  </reference>
  <reference>
    <citation>Michelson JD, Magid D, McHale K. Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma. 2007 May;21(5):307-15. doi: 10.1097/BOT.0b013e318059aea3.</citation>
    <PMID>17485995</PMID>
  </reference>
  <reference>
    <citation>Dehghan N, McKee MD, Jenkinson RJ, Schemitsch EH, Stas V, Nauth A, Hall JA, Stephen DJ, Kreder HJ. Early Weightbearing and Range of Motion Versus Non-Weightbearing and Immobilization After Open Reduction and Internal Fixation of Unstable Ankle Fractures: A Randomized Controlled Trial. J Orthop Trauma. 2016 Jul;30(7):345-52. doi: 10.1097/BOT.0000000000000572.</citation>
    <PMID>27045369</PMID>
  </reference>
  <reference>
    <citation>Gul A, Batra S, Mehmood S, Gillham N. Immediate unprotected weight-bearing of operatively treated ankle fractures. Acta Orthop Belg. 2007 Jun;73(3):360-5.</citation>
    <PMID>17715727</PMID>
  </reference>
  <reference>
    <citation>O'Sullivan ME, Bronk JT, Chao EY, Kelly PJ. Experimental study of the effect of weight bearing on fracture healing in the canine tibia. Clin Orthop Relat Res. 1994 May;(302):273-83.</citation>
    <PMID>8168314</PMID>
  </reference>
  <reference>
    <citation>Lehtonen H, Jarvinen TL, Honkonen S, Nyman M, Vihtonen K, Jarvinen M. Use of a cast compared with a functional ankle brace after operative treatment of an ankle fracture. A prospective, randomized study. J Bone Joint Surg Am. 2003 Feb;85(2):205-11. doi: 10.2106/00004623-200302000-00004.</citation>
    <PMID>12571295</PMID>
  </reference>
  <reference>
    <citation>Honigmann P, Goldhahn S, Rosenkranz J, Audige L, Geissmann D, Babst R. Aftertreatment of malleolar fractures following ORIF -- functional compared to protected functional in a vacuum-stabilized orthesis: a randomized controlled trial. Arch Orthop Trauma Surg. 2007 Apr;127(3):195-203. doi: 10.1007/s00402-006-0255-x. Epub 2006 Dec 30.</citation>
    <PMID>17195934</PMID>
  </reference>
  <reference>
    <citation>van Laarhoven CJ, Meeuwis JD, van der WerkenC. Postoperative treatment of internally fixed ankle fractures: a prospective randomised study. J Bone Joint Surg Br. 1996 May;78(3):395-9.</citation>
    <PMID>8636173</PMID>
  </reference>
  <reference>
    <citation>Ahl T, Dalen N, Lundberg A, Bylund C. Early mobilization of operated on ankle fractures. Prospective, controlled study of 40 bimalleolar cases. Acta Orthop Scand. 1993 Feb;64(1):95-9. doi: 10.3109/17453679308994541.</citation>
    <PMID>8451961</PMID>
  </reference>
  <reference>
    <citation>Finsen V, Saetermo R, Kibsgaard L, Farran K, Engebretsen L, Bolz KD, Benum P. Early postoperative weight-bearing and muscle activity in patients who have a fracture of the ankle. J Bone Joint Surg Am. 1989 Jan;71(1):23-7.</citation>
    <PMID>2492286</PMID>
  </reference>
  <reference>
    <citation>Cimino W, Ichtertz D, Slabaugh P. Early mobilization of ankle fractures after open reduction and internal fixation. Clin Orthop Relat Res. 1991 Jun;(267):152-6.</citation>
    <PMID>2044269</PMID>
  </reference>
  <reference>
    <citation>Hedstrom M, Ahl T, Dalen N. Early postoperative ankle exercise. A study of postoperative lateral malleolar fractures. Clin Orthop Relat Res. 1994 Mar;(300):193-6.</citation>
    <PMID>8131334</PMID>
  </reference>
  <reference>
    <citation>Egol KA, Dolan R, Koval KJ. Functional outcome of surgery for fractures of the ankle. A prospective, randomised comparison of management in a cast or a functional brace. J Bone Joint Surg Br. 2000 Mar;82(2):246-9.</citation>
    <PMID>10755435</PMID>
  </reference>
  <reference>
    <citation>Smeeing DP, Houwert RM, Briet JP, Kelder JC, Segers MJ, Verleisdonk EJ, Leenen LP, Hietbrink F. Weight-bearing and mobilization in the postoperative care of ankle fractures: a systematic review and meta-analysis of randomized controlled trials and cohort studies. PLoS One. 2015 Feb 19;10(2):e0118320. doi: 10.1371/journal.pone.0118320. eCollection 2015.</citation>
    <PMID>25695796</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ankle, fracture, rehabilitation, weightbearing, early, late</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Ankle Fractures</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/NCT03032653
org study id: FHREB #: 2016-101
nct id: NCT03032653
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This single-centre historical control group comparative study will compare outcomes of
      surgically-treated rotational ankle fractures and the current routine practice of early
      protected weightbearing and range of motion with immediate unprotected weightbearing as
      tolerated and range of motion after ankle open reduction and internal fixation.
Ankle fractures are among the most common injuries, making up 9% of all fractures. Rotational
      ankle fractures are among the most common of all fractures, with an incidence averaging 4.2
      per 1,000 individuals annually. These fractures range from minimal injuries amenable to
      non-surgical management to complex injuries with potential of long-term sequelae. Known risk
      factors for ankle fractures are age, body mass index and previous ankle fracture, with the
      highest incidence in elderly women.

      Most ankle fractures are low-energy injuries which occur when the body rotates about a
      planted foot, whether it be during sports, normal gait, or otherwise. Stable ankle fractures
      are generally treated non-surgically, while unstable fractures are usually treated with
      surgical reduction and fixation, with indications previously well-described and published.

      However, the post-operative management of such injuries is still controversial, with large
      variability between care providers. Protocols range from complete immobilization of the
      affected ankle and non-weightbearing to early range-of-motion (ROM) and weightbearing (WB).
      Studies have compared immobilization and non-WB to early ROM and WB but results have been
      mixed, with the most recent study demonstrating safety and advantages to protected WB and ROM
      at two weeks post-operatively versus non-WB and immobilization for six weeks.

      The Investigators intend to expand on the studies above and propose a single-centre
      historical control group comparative study to compare outcomes of surgically-treated
      rotational ankle fractures and the current routine practice of early protected weightbearing
      and range of motion with immediate unprotected weightbearing as tolerated and range of motion
      after ankle open reduction and internal fixation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Olerud and Molander Score
time frame: 6 weeks post treatment
description: An assessment of symptoms after ankle fracture.
measure: EQ-5D
time frame: 2, 6 and 12 weeks post treatment
description: Health Related quality of life outcome measure using five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
measure: WPAI:SHP Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
time frame: 2, 6 and 12 weeks post treatment
description: A questionnaire pertaining to the effect of the participant's ankle fracture on their ability to work and perform regular activities.
measure: Range of Motion
time frame: 2, 6 and 12 weeks post treatment
description: Amount of ankle dorsiflexion and plantarflexion (measured in degrees) as determined by goniometer assessment, as well as total arc of ankle ROM (dorsiflexion+ plantarflexion). This will be measured on both ankles for comparison.
measure: Wound Healing
time frame: 2, 6 and 12 weeks post treatment
description: Complications regarding the surgical wound, including but not limited to signs of infection or dehiscence.
measure: Fracture Healing
time frame: 2, 6 and 12 weeks post treatment
description: Radiographic assessment to determine healing, loss of reduction, loss of hardware fixation, or ankle alignment.
measure: Need for Re-operation
time frame: 2, 6 and 12 weeks post treatment
description: Any issue, whether it be a wound complication or fracture complication, requiring re-operation.
measure: Time to Return to Work
time frame: 2, 6 and 12 weeks post treatment
description: The chronological time between the date of surgery to the first day the participant returned to occupational duties, if currently employed and returns to work within the 12 weeks postoperative follow-up period. For the purposes of this study, students enrolled in educational activities will have their schooling treated as their occupational duty.
measure: Radiographic assessment
time frame: 2, 6 and 12 weeks post treatment
description: Assessment of alignment, hardware fixation, fracture reduction and loss of reduction (defined as any shft of 2mm or more in fracture position)
arm group label: Late WB
arm group type: Active Comparator
description: Intervention: Patients receive a plaster splint in the operating room. They are not permitted to WB or ROM on the affected limb at this stage. At the first follow-up appointment (two weeks post-op), the splint is removed and a removable pre-fabricated walking boot applied. At this stage the patient is permitted to WB as tolerated while wearing the boot, and to perform ROM exercises with the boot removed. At six weeks post-op, the boot is discontinued and full unrestricted and unprotected weightbearing and ROM is permitted.
arm group label: Immediate unprotected WB and ROM
arm group type: Experimental
description: Patient do NOT receive a brace or splint of any kind. They are permitted to weightbear and range of motion as tolerated within the limitations of their own comfort. Use of ambulatory aids of any kind is permitted as needed without restrictions.
intervention type: Other
intervention name: Late Rehabilitation
description: Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot.
6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:
arm group label: Late WB
intervention type: Other
intervention name: Early Rehabilitation
description: Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted
arm group label: Immediate unprotected WB and ROM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Darius G Viskontas, MD, FRCSC
role: Principal Investigator
affiliation: Royal Columbian Hospital / Fraser Health Authority
last name: Vu (Brian) Le, MD, FRSCS
role: Principal Investigator
affiliation: Royal Columbian Hospital / Fraser Health Authority
last name: Kelly L Apostle, MD, FRCSC
role: Principal Investigator
affiliation: Royal Columbian Hospital / Fraser Health Authority
facility: 
country: Canada
citation: Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006 Aug;37(8):691-7. doi: 10.1016/j.injury.2006.04.130. Epub 2006 Jun 30.
PMID: 16814787
citation: Hoelsbrekken SE, Kaul-Jensen K, Morch T, Vika H, Clementsen T, Paulsrud O, Petursson G, Stiris M, Stromsoe K. Nonoperative treatment of the medial malleolus in bimalleolar and trimalleolar ankle fractures: a randomized controlled trial. J Orthop Trauma. 2013 Nov;27(11):633-7. doi: 10.1097/BOT.0b013e31828e1bb7.
PMID: 23454858
citation: Petrisor BA, Poolman R, Koval K, Tornetta P 3rd, Bhandari M; Evidence-Based Orthopaedic Trauma Working Group. Management of displaced ankle fractures. J Orthop Trauma. 2006 Jul;20(7):515-8. doi: 10.1097/00005131-200608000-00012.
PMID: 16891946
citation: Michelson JD, Magid D, McHale K. Clinical utility of a stability-based ankle fracture classification system. J Orthop Trauma. 2007 May;21(5):307-15. doi: 10.1097/BOT.0b013e318059aea3.
PMID: 17485995
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responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Ankle Fractures
sharing ipd: No