<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/NCT04432740</url>
  </required_header>
  <id_info>
    <org_study_id>B.10.1.TKH.4.34.H.GP.0.01/45</org_study_id>
    <nct_id>NCT04432740</nct_id>
  </id_info>
  <brief_title>A Novel Splint Technique for Distal Radius Treatment</brief_title>
  <official_title>Clinical Outcomes Comparison of Distal Radius Fractures Between Two Conservative Treatment Methods: Below-Arm Cast Versus Reverse Sugar Tong Splint</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</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>
      There are many conservative treatment methods, including below arm cast, above arm cast, and&#xD;
      sugar tong splint that aim to obtain maximum functional, clinical, and radiological results&#xD;
      There are no clear indications with regard to the best treatment including conservative or&#xD;
      surgical methods for the different fracture subtypes in distal radius fracture. The purpose&#xD;
      of this prospective randomized study was to compare a new reverse sugar tong splint technique&#xD;
      that does not immobilize the elbow with a below-arm cast, in terms of patient radiological&#xD;
      and clinical outcomes and the ability to maintain fracture reduction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted at a single Orthopedics and Traumatology emergency department center&#xD;
      between April 2017 and March 2019. A two-arm, parallel-group, prospective randomized trial&#xD;
      was conducted to compare below-arm cast (BAC) and reverse sugar tong (RST) (described below)&#xD;
      treatment of DRF.&#xD;
&#xD;
      Overall, 231 patients diagnosed with distal radius fracture in the emergency department&#xD;
      received prospective treatment.&#xD;
&#xD;
      Inclusion criteria: Patients aged &gt;18 years and with distal radius fracture type A and B (who&#xD;
      presented within 10 days of the injury) were considered for inclusion.&#xD;
&#xD;
      Exclusion criteria: Patients with AO type C distal radius fractures (treated surgically),&#xD;
      type 2 and 3 open fractures (according to Gustilo classification), previous hand or wrist&#xD;
      surgery, fractures in the concomitant side of the upper extremities, associate carpal&#xD;
      fracture, deformity on same extremity, pathological fractures, and cognitive deficit that&#xD;
      does not allow the patient to understand the functional evaluation were excluded from this&#xD;
      study. Lastly, patients who did not return for a follow-up visit at the end of the cast or&#xD;
      splint treatment were also excluded.&#xD;
&#xD;
      Patient selection and treatment methods Sample Size: The sample size was calculated based on&#xD;
      a 15-20% difference in complication rate between the two treatment groups, an alpha level of&#xD;
      5% and a power of 80%. Consequently, each group shall at least consist of 55 participants. We&#xD;
      considered an extra 20% who loss of follow-up or loss of reduction and surgery may require&#xD;
      for balancing sample size. With expectation of dropouts70 patients per group were included.&#xD;
&#xD;
      All the initial fractures of the patients were classified by the same author using the AO&#xD;
      classification. Patients were randomly allocated to a treatment group using an electronic&#xD;
      random number generator, with those having an even number assigned to the BAC group and those&#xD;
      having an odd number to the RST group. Treatment in both the BAC and RST groups was conducted&#xD;
      by the same investigator. The reduction obtained was checked on AP and lateral x-ray of the&#xD;
      wrist, which were then used to calculate the following baseline radiological parameters:&#xD;
      radial inclination (RI), radial height (RH), and volar tilt (VT).&#xD;
&#xD;
      Follow-up Management Clinical and radiological follow-up was performed 7-10 days (initial&#xD;
      follow-up), three weeks, 5 or 6 weeks, 12 weeks and one year (last follow-up) after the&#xD;
      treatment. X-rays at the initial follow-up which was performed 7-10 days after the initial&#xD;
      closed reduction were taken with the cast or splint in place. Maintenance of fracture&#xD;
      reduction was defined as a loss of reduction of less than 2 mm of radial height, 5° of radial&#xD;
      inclination or 10° of volar tilt from the initial reduction films, and/or less than 2 mm of&#xD;
      intra-articular step-off. In the initial follow-up, third week, and 6th week visit, patients&#xD;
      were evaluated with x-ray to detect cast and splint complications, including those that&#xD;
      require cast wedging or valving to reduce the pressure and the presence of complex regional&#xD;
      pain syndrome (CRPS). Both treatments were removed during the 5-6th week visit in all groups.&#xD;
&#xD;
      Functional outcomes The validated quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)&#xD;
      questionnaire score and the Mayo Elbow Performance score (MEPS) score were used to measure&#xD;
      clinical outcomes.These scores were performed at the12th week and last follow-up visit for&#xD;
      all the patients. Both groups were also evaluated with the Health Assessment Questionnaire&#xD;
      (HAQ) at the 6th week visit for health status.&#xD;
&#xD;
      Radiological evaluation All the radiological parameters were measured by the same author at&#xD;
      two time points: initial visit postreduction and 6th visit after the end of treatment. Radial&#xD;
      height, Radial inclination and Volar tilt were measured separetly.&#xD;
&#xD;
      Clinical evaluations The wrist range of motion was measured in degree, using a goniometer,&#xD;
      from the neutral position to flexion, extension, radial deviation, and ulnar deviation by&#xD;
      same investigator during the last follow-up visit. The forearm rotation was also measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2017</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 20, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fracture Healing Outcome</measure>
    <time_frame>6th week</time_frame>
    <description>All patients were evaluated fracture healing with x-ray view which assessment of radiological union by observing the presence of bridging callus or the obscuration of the fracture line.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health relaated quality of life</measure>
    <time_frame>6th week</time_frame>
    <description>Both groups were also evaluated with the Health Assessment Questionnaire (HAQ) for quality of life. The HAQ score is a feasible scale consisting of 8 different categories totally with 20 items which beneficial for assessing the functional disabilities during activities of daily living which is the increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Complications Outcomes</measure>
    <time_frame>1st week, 3rd week and 6th week</time_frame>
    <description>All patients were evaluated with x-ray to detect cast and splint complications, including those that loss of reduction, require cast wedging or valving to reduce the pressure and the presence of complex regional pain syndrome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes</measure>
    <time_frame>12th week and 1st year</time_frame>
    <description>Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire score was used to measure clinical outcomes.To calculate a QuickDASH score, at least 10 of the 11 items must be completed. Similar to the DASH, each item has 5 response options and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes</measure>
    <time_frame>12th week and 1st year</time_frame>
    <description>Mayo Elbow Performance score (MEPS) score was used to measure clinical outcomes.The MEPS measures elbow function across four domains: pain (45 points), stability (10 points), range of motion (20 points), and daily functional tasks (25 points). Scores are categorized as 90-100 = excellent, 75-89 = good, 60-74 = fair, 0-59 = poor.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Distal Radius Fracture</condition>
  <condition>Complication of Treatment</condition>
  <arm_group>
    <arm_group_label>Below Arm Cast Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All the patients were prepared in the supine position at the emergency department. For analgesia, we used the hematoma block technique with 3 cc of 2% prilocaine hydrochloride®. In this group, after traction was applied using a finger-trap traction with a 4.5 kg weight for 5 minutes, the standard below arm cast was applied. Patients were encouraged to actively move their fingers, ipsilateral shoulder, and elbow in all the groups. Both treatments lasted 5 or 6 weeks after at our clinic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reverse Sugar Tong Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group, after traction was applied using a finger-trap traction with a 4.5 kg weight for 5 minutes, sugar tong splint made of 12 layers of plaster was performed by one person. The reverse sugar tong splint succeeds as a classic sugar tong splint by stabilizing the volar and dorsal aspects of the wrist and forearm, maintaining the same degree of immobilization. The splint fold is located distally at the first web space of the hand, which does not immobilize the elbow. In all the groups, the wrist immobilization position was the same; pronated forearm, 15-20° wrist flexion, ulnar deviation, and care was taken not to immobilize the metacarpophalangeal joints. Patients were encouraged to actively move their fingers, ipsilateral shoulder, and elbow in all the groups. Both treatments lasted 5 or 6 weeks after at our clinic</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conservative Treatment of Distal Radius Fracture</intervention_name>
    <description>The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.</description>
    <arm_group_label>Below Arm Cast Group</arm_group_label>
    <arm_group_label>Reverse Sugar Tong Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt;18 years,&#xD;
&#xD;
          -  with distal radius fracture type A and B (who presented within 10 days of the injury)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with AO type C distal radius fractures (treated surgically),&#xD;
&#xD;
          -  type 2 and 3 open fractures (according to Gustilo classification),&#xD;
&#xD;
          -  previous hand or wrist surgery,&#xD;
&#xD;
          -  fractures in the concomitant side of the upper extremities,&#xD;
&#xD;
          -  associate carpal fracture, deformity on the same extremity,&#xD;
&#xD;
          -  pathological fractures,&#xD;
&#xD;
          -  cognitive deficit that does not allow the patient to understand the functional&#xD;
             evaluation&#xD;
&#xD;
          -  patients who did not return for a follow-up visit at the end of the cast or splint&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>61 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Umraniye Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Umraniye</state>
        <zip>34760</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Savaş Çamur</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>distal radius fracture</keyword>
  <keyword>conservative treatment</keyword>
  <keyword>reverse sugar tong</keyword>
  <keyword>below arm cast</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
    <mesh_term>Wrist 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/NCT04432740
org study id: B.10.1.TKH.4.34.H.GP.0.01/45
nct id: NCT04432740
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are many conservative treatment methods, including below arm cast, above arm cast, and
      sugar tong splint that aim to obtain maximum functional, clinical, and radiological results
      There are no clear indications with regard to the best treatment including conservative or
      surgical methods for the different fracture subtypes in distal radius fracture. The purpose
      of this prospective randomized study was to compare a new reverse sugar tong splint technique
      that does not immobilize the elbow with a below-arm cast, in terms of patient radiological
      and clinical outcomes and the ability to maintain fracture reduction.
This study was conducted at a single Orthopedics and Traumatology emergency department center
      between April 2017 and March 2019. A two-arm, parallel-group, prospective randomized trial
      was conducted to compare below-arm cast (BAC) and reverse sugar tong (RST) (described below)
      treatment of DRF.

      Overall, 231 patients diagnosed with distal radius fracture in the emergency department
      received prospective treatment.

      Inclusion criteria: Patients aged >18 years and with distal radius fracture type A and B (who
      presented within 10 days of the injury) were considered for inclusion.

      Exclusion criteria: Patients with AO type C distal radius fractures (treated surgically),
      type 2 and 3 open fractures (according to Gustilo classification), previous hand or wrist
      surgery, fractures in the concomitant side of the upper extremities, associate carpal
      fracture, deformity on same extremity, pathological fractures, and cognitive deficit that
      does not allow the patient to understand the functional evaluation were excluded from this
      study. Lastly, patients who did not return for a follow-up visit at the end of the cast or
      splint treatment were also excluded.

      Patient selection and treatment methods Sample Size: The sample size was calculated based on
      a 15-20% difference in complication rate between the two treatment groups, an alpha level of
      5% and a power of 80%. Consequently, each group shall at least consist of 55 participants. We
      considered an extra 20% who loss of follow-up or loss of reduction and surgery may require
      for balancing sample size. With expectation of dropouts70 patients per group were included.

      All the initial fractures of the patients were classified by the same author using the AO
      classification. Patients were randomly allocated to a treatment group using an electronic
      random number generator, with those having an even number assigned to the BAC group and those
      having an odd number to the RST group. Treatment in both the BAC and RST groups was conducted
      by the same investigator. The reduction obtained was checked on AP and lateral x-ray of the
      wrist, which were then used to calculate the following baseline radiological parameters:
      radial inclination (RI), radial height (RH), and volar tilt (VT).

      Follow-up Management Clinical and radiological follow-up was performed 7-10 days (initial
      follow-up), three weeks, 5 or 6 weeks, 12 weeks and one year (last follow-up) after the
      treatment. X-rays at the initial follow-up which was performed 7-10 days after the initial
      closed reduction were taken with the cast or splint in place. Maintenance of fracture
      reduction was defined as a loss of reduction of less than 2 mm of radial height, 5° of radial
      inclination or 10° of volar tilt from the initial reduction films, and/or less than 2 mm of
      intra-articular step-off. In the initial follow-up, third week, and 6th week visit, patients
      were evaluated with x-ray to detect cast and splint complications, including those that
      require cast wedging or valving to reduce the pressure and the presence of complex regional
      pain syndrome (CRPS). Both treatments were removed during the 5-6th week visit in all groups.

      Functional outcomes The validated quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)
      questionnaire score and the Mayo Elbow Performance score (MEPS) score were used to measure
      clinical outcomes.These scores were performed at the12th week and last follow-up visit for
      all the patients. Both groups were also evaluated with the Health Assessment Questionnaire
      (HAQ) at the 6th week visit for health status.

      Radiological evaluation All the radiological parameters were measured by the same author at
      two time points: initial visit postreduction and 6th visit after the end of treatment. Radial
      height, Radial inclination and Volar tilt were measured separetly.

      Clinical evaluations The wrist range of motion was measured in degree, using a goniometer,
      from the neutral position to flexion, extension, radial deviation, and ulnar deviation by
      same investigator during the last follow-up visit. The forearm rotation was also measured.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Fracture Healing Outcome
time frame: 6th week
description: All patients were evaluated fracture healing with x-ray view which assessment of radiological union by observing the presence of bridging callus or the obscuration of the fracture line.
measure: Health relaated quality of life
time frame: 6th week
description: Both groups were also evaluated with the Health Assessment Questionnaire (HAQ) for quality of life. The HAQ score is a feasible scale consisting of 8 different categories totally with 20 items which beneficial for assessing the functional disabilities during activities of daily living which is the increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.
measure: Rate of Complications Outcomes
time frame: 1st week, 3rd week and 6th week
description: All patients were evaluated with x-ray to detect cast and splint complications, including those that loss of reduction, require cast wedging or valving to reduce the pressure and the presence of complex regional pain syndrome.
measure: Functional Outcomes
time frame: 12th week and 1st year
description: Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire score was used to measure clinical outcomes.To calculate a QuickDASH score, at least 10 of the 11 items must be completed. Similar to the DASH, each item has 5 response options and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).
measure: Functional Outcomes
time frame: 12th week and 1st year
description: Mayo Elbow Performance score (MEPS) score was used to measure clinical outcomes.The MEPS measures elbow function across four domains: pain (45 points), stability (10 points), range of motion (20 points), and daily functional tasks (25 points). Scores are categorized as 90-100 = excellent, 75-89 = good, 60-74 = fair, 0-59 = poor.
arm group label: Below Arm Cast Group
arm group type: Active Comparator
description: All the patients were prepared in the supine position at the emergency department. For analgesia, we used the hematoma block technique with 3 cc of 2% prilocaine hydrochloride®. In this group, after traction was applied using a finger-trap traction with a 4.5 kg weight for 5 minutes, the standard below arm cast was applied. Patients were encouraged to actively move their fingers, ipsilateral shoulder, and elbow in all the groups. Both treatments lasted 5 or 6 weeks after at our clinic
arm group label: Reverse Sugar Tong Group
arm group type: Active Comparator
description: In this group, after traction was applied using a finger-trap traction with a 4.5 kg weight for 5 minutes, sugar tong splint made of 12 layers of plaster was performed by one person. The reverse sugar tong splint succeeds as a classic sugar tong splint by stabilizing the volar and dorsal aspects of the wrist and forearm, maintaining the same degree of immobilization. The splint fold is located distally at the first web space of the hand, which does not immobilize the elbow. In all the groups, the wrist immobilization position was the same; pronated forearm, 15-20° wrist flexion, ulnar deviation, and care was taken not to immobilize the metacarpophalangeal joints. Patients were encouraged to actively move their fingers, ipsilateral shoulder, and elbow in all the groups. Both treatments lasted 5 or 6 weeks after at our clinic
intervention type: Procedure
intervention name: Conservative Treatment of Distal Radius Fracture
description: The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.
arm group label: Below Arm Cast Group
arm group label: Reverse Sugar Tong Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 61 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Savaş Çamur
investigator title: Principal Investigator
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Wrist Fractures
sharing ipd: No