<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/NCT04479397</url>
  </required_header>
  <id_info>
    <org_study_id>2019-02469</org_study_id>
    <nct_id>NCT04479397</nct_id>
  </id_info>
  <brief_title>Sling vs Nothing After Latarjet Procedure</brief_title>
  <official_title>Post-operative Mobilization After Anterior Shoulder Stabilization With the Latarjet Procedure: Sling Versus Nothing. A Randomized Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hugo Bothorel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>La Tour Hospital</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>
      Traumatic anterior shoulder instability is a common injury for the contact athlete, with high&#xD;
      rates of recurrence in some athletic populations. The specific indication for the Latarjet&#xD;
      procedure differs amongst surgeons, however it is generally accepted that it is indicated in&#xD;
      patients with anterior glenohumeral instability that are unlikely to have a successful&#xD;
      outcome from either an arthroscopic or open anatomical Bankart repair.&#xD;
&#xD;
      Overall the rate of reoperation following a Latarjet is around 5-7%. Infection, hematoma as&#xD;
      well as screw removal and glenoid bony rim fractures are the most common indications for&#xD;
      reoperation. The rate of instability after a Latarjet is low, with 1.7%-5.0% rate of&#xD;
      dislocation.&#xD;
&#xD;
      However, in terms of rehabilitation, there are only a few studies and evidence of best&#xD;
      practices. A recent review of the literature has highlighted four studies, comparing&#xD;
      different rehabilitation protocols, which include different immobilization periods ranging&#xD;
      from 0 to 3 weeks, and different types of mobilization (under physiotherapist supervision or&#xD;
      not, with machine or not). They found a similar rate of recurrent dislocation between the&#xD;
      different protocols. But early passive motion enables to improve the range of motion during&#xD;
      first 3-6 months, with similar results at one year.&#xD;
&#xD;
      One main aspect which the surgeon can influence is immobilization time. In all&#xD;
      above-mentioned studies, patients had to wear a sling for at least 3 weeks, even in the early&#xD;
      mobilization groups. Short protocols with encouraging results have been recently emphasized&#xD;
      by in other fields of shoulder surgery. The investigators would like to determine if the&#xD;
      absence of postoperative immobilization could lead to improved function and better range of&#xD;
      motion. To the investigators best knowledge, no study has sought to compare the usefulness of&#xD;
      sling wearing after Latarjet procedure. Avoiding the sling could simplify rehabilitation and&#xD;
      should provide a return to normal function faster.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to compare rehabilitation with the wearing of a sling, to&#xD;
      rehabilitation without any immobilization after Latarjet procedure for treatment of anterior&#xD;
      shoulder instability. Ultimately, the goal would be to offer to patients a simplified&#xD;
      rehabilitation management, with a faster recovery, less pain and a quicker return to&#xD;
      activities of daily living, work and sport.&#xD;
&#xD;
      As primary outcome, investigators will evaluate if the Rowe score is superior without&#xD;
      postoperative immobilization (without a sling during the first 3 weeks) at 6 months after&#xD;
      surgery compared to sling wearing.&#xD;
&#xD;
      Secondary outcomes include radiological criteria (X-rays and computed tomography (CT) at 6&#xD;
      months for bony union), return to sport, work absenteeism, other complication rate&#xD;
      (especially redislocation), and the undermentioned subjective and clinical scores before&#xD;
      surgery and at 1.5, 6 and 12 postoperative months.&#xD;
&#xD;
      All patients will be assessed with commonly used subjective scores in the form of&#xD;
      self-administered questionnaires. The Visual Analog Scale (VAS) is a widely used single-item&#xD;
      test where a patient rates pain intensity between 0 and 10. This scale is useful for patient&#xD;
      preoperative and postoperative monitoring and has also been correlated with patient pain,&#xD;
      anxiety and apprehension. Patient satisfaction (are patients satisfied, yes/no) will be&#xD;
      assessed as well. Subjective Shoulder Value (SSV) is a single-question test where a patient&#xD;
      is asked to rate his overall shoulder function as a percentage of normal shoulder. It is a&#xD;
      quick and easily administered score that has also been validated for various shoulder&#xD;
      disabilities, such as instability.&#xD;
&#xD;
      The following clinical scores will be analyzed as well Rowe score for instability is a&#xD;
      three-item test with four choices each, measuring shoulder function, stability, and motion.&#xD;
      The final result is converted into a value between 0 and 100. These scores have been&#xD;
      specifically developed for shoulder instability.&#xD;
&#xD;
      Except for VAS, higher results mean higher function. ROM will be determined using a Vicon&#xD;
      motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling&#xD;
      at 120 Hz already available in our facility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2022</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rowe score</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>The Rowe Score consists of a total of 100 points divided into three domains: (1) stability, which corresponds to a total 50 points; (2) mobility, which corresponds to 20 points; (3) function, which corresponds to 30 points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Visual Analog Scale (VAS)</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>The Visual Analog Scale (VAS) is a widely used single-item test where a patient rates pain intensity between 0 and 10. This scale is useful for patient preoperative and postoperative monitoring and has also been correlated with patient pain, anxiety and apprehension.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Shoulder Value (SSV)</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>The SSV is defined as a patient's subjective shoulder assessment expressed as a percent- age of an entirely normal shoulder, which would score 100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>Patients will be asked &quot;are you satisfied, yes/no&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bony union</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>Will be evaluated using a CT scan and/or X-ray</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>Time, in days, till patients return to work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to sport</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>Time, in days, untill patients return to sports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Redislocation</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>Did the shoulder redislocate postoperatively, yes or no</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>12 postoperative months</time_frame>
    <description>ROM will be determined using a Vicon motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling at 120 Hz already available in our facility.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Shoulder Dislocation</condition>
  <arm_group>
    <arm_group_label>Sling Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm of the study will receive a sling for 3 weeks in postoperative care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Sling Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm of the study will not receive a sling during the postoperative care,</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Latarjet Surgery for anterior shoulder instability</intervention_name>
    <description>Bone block procedure for anterior shoulder instability</description>
    <arm_group_label>No Sling Arm</arm_group_label>
    <arm_group_label>Sling Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No sling in postoperative care</intervention_name>
    <description>No sling will be used in postoperative care.</description>
    <arm_group_label>No Sling Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients over 18 years old who have an anterior shoulder instability with one of&#xD;
             the following criteria: an anterior glenoid bone defect &gt; 20%, contact athlete or&#xD;
             patients with failed Bankart repair-either open or arthroscopic will be considered&#xD;
             eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We exclude patients with a subscapularis tear, other trauma of the involved upper&#xD;
             extremity (e.g. associated scapular or clavicular fractures, acromioclavicular&#xD;
             dislocation), pre-operative stiffness, pre-operative sign of dislocation on standard&#xD;
             X-ray, CT, CT arthrogram, MRI or MRA, contra-indication to CT (i.e pregnancy), and an&#xD;
             inability to follow properly post-surgery recommendations.&#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_contact>
    <last_name>Alexandre Lädermann, PD Dr</last_name>
    <phone>+41227197555</phone>
    <email>alexandre.laedermann@latour.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>La Tour Hospital</name>
      <address>
        <city>Meyrin</city>
        <state>Geneva</state>
        <zip>1217</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre Lädermann, MD</last_name>
      <phone>+41227197555</phone>
      <email>alexandre.laedermann@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <citation>Griesser MJ, Harris JD, McCoy BW, Hussain WM, Jones MH, Bishop JY, Miniaci A. Complications and re-operations after Bristow-Latarjet shoulder stabilization: a systematic review. J Shoulder Elbow Surg. 2013 Feb;22(2):286-92. doi: 10.1016/j.jse.2012.09.009.</citation>
    <PMID>23352473</PMID>
  </reference>
  <results_reference>
    <citation>Whitehouse T, Orr R, Fitzgerald E, Harries S, McLellan CP. The Epidemiology of Injuries in Australian Professional Rugby Union 2014 Super Rugby Competition. Orthop J Sports Med. 2016 Mar 22;4(3):2325967116634075. doi: 10.1177/2325967116634075. eCollection 2016 Mar.</citation>
    <PMID>27069947</PMID>
  </results_reference>
  <results_reference>
    <citation>van der Linde JA, van Wijngaarden R, Somford MP, van Deurzen DF, van den Bekerom MP. The Bristow-Latarjet procedure, a historical note on a technique in comeback. Knee Surg Sports Traumatol Arthrosc. 2016 Feb;24(2):470-8. doi: 10.1007/s00167-015-3704-7. Epub 2015 Aug 1.</citation>
    <PMID>26231148</PMID>
  </results_reference>
  <results_reference>
    <citation>An VV, Sivakumar BS, Phan K, Trantalis J. A systematic review and meta-analysis of clinical and patient-reported outcomes following two procedures for recurrent traumatic anterior instability of the shoulder: Latarjet procedure vs. Bankart repair. J Shoulder Elbow Surg. 2016 May;25(5):853-63. doi: 10.1016/j.jse.2015.11.001. Epub 2016 Jan 19.</citation>
    <PMID>26809355</PMID>
  </results_reference>
  <results_reference>
    <citation>Cunningham G, Ladermann A. Redefining anterior shoulder impingement: a literature review. Int Orthop. 2018 Feb;42(2):359-366. doi: 10.1007/s00264-017-3515-1. Epub 2017 Jun 6.</citation>
    <PMID>28585076</PMID>
  </results_reference>
  <results_reference>
    <citation>Ma R, Brimmo OA, Li X, Colbert L. Current Concepts in Rehabilitation for Traumatic Anterior Shoulder Instability. Curr Rev Musculoskelet Med. 2017 Dec;10(4):499-506. doi: 10.1007/s12178-017-9449-9.</citation>
    <PMID>29038953</PMID>
  </results_reference>
  <results_reference>
    <citation>Ialenti MN, Mulvihill JD, Feinstein M, Zhang AL, Feeley BT. Return to Play Following Shoulder Stabilization: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2017 Sep 14;5(9):2325967117726055. doi: 10.1177/2325967117726055. eCollection 2017 Sep.</citation>
    <PMID>28944249</PMID>
  </results_reference>
  <results_reference>
    <citation>Young AA, Maia R, Berhouet J, Walch G. Open Latarjet procedure for management of bone loss in anterior instability of the glenohumeral joint. J Shoulder Elbow Surg. 2011 Mar;20(2 Suppl):S61-9. doi: 10.1016/j.jse.2010.07.022. Epub 2010 Dec 9. No abstract available.</citation>
    <PMID>21145262</PMID>
  </results_reference>
  <results_reference>
    <citation>Ladermann A, Lubbeke A, Stern R, Cunningham G, Bellotti V, Gazielly DF. Risk factors for dislocation arthropathy after Latarjet procedure: a long-term study. Int Orthop. 2013 Jun;37(6):1093-8. doi: 10.1007/s00264-013-1848-y. Epub 2013 Mar 13.</citation>
    <PMID>23508865</PMID>
  </results_reference>
  <results_reference>
    <citation>Cunningham G, Benchouk S, Kherad O, Ladermann A. Comparison of arthroscopic and open Latarjet with a learning curve analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Feb;24(2):540-5. doi: 10.1007/s00167-015-3910-3. Epub 2015 Dec 12.</citation>
    <PMID>26658571</PMID>
  </results_reference>
  <results_reference>
    <citation>Tirefort J, Schwitzguebel AJ, Collin P, Nowak A, Plomb-Holmes C, Ladermann A. Postoperative Mobilization After Superior Rotator Cuff Repair: Sling Versus No Sling: A Randomized Prospective Study. J Bone Joint Surg Am. 2019 Mar 20;101(6):494-503. doi: 10.2106/JBJS.18.00773.</citation>
    <PMID>30893230</PMID>
  </results_reference>
  <results_reference>
    <citation>Domos P, Lunini E, Ascione F, Serra N, Bercik MJ, Neyton L, Godeneche A, Walch G. Clinical and radiographic outcomes of open Latarjet procedure in patients aged 40 years or older. J Shoulder Elbow Surg. 2019 Sep;28(9):e304-e312. doi: 10.1016/j.jse.2019.02.004. Epub 2019 Apr 28.</citation>
    <PMID>31043350</PMID>
  </results_reference>
  <results_reference>
    <citation>Boileau P, Saliken D, Gendre P, Seeto BL, d'Ollonne T, Gonzalez JF, Bronsard N. Arthroscopic Latarjet: Suture-Button Fixation Is a Safe and Reliable Alternative to Screw Fixation. Arthroscopy. 2019 Apr;35(4):1050-1061. doi: 10.1016/j.arthro.2018.11.012. Epub 2019 Mar 8.</citation>
    <PMID>30857907</PMID>
  </results_reference>
  <results_reference>
    <citation>Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.</citation>
    <PMID>18061114</PMID>
  </results_reference>
  <results_reference>
    <citation>Martinez-Urrutia A. Anxiety and pain in surgical patients. J Consult Clin Psychol. 1975 Aug;43(4):437-42. doi: 10.1037/h0076898. No abstract available.</citation>
    <PMID>1159142</PMID>
  </results_reference>
  <results_reference>
    <citation>Cunningham G, Zanchi D, Emmert K, Kopel R, Van De Ville D, Ladermann A, Haller S, Hoffmeyer P. Neural Correlates of Clinical Scores in Patients with Anterior Shoulder Apprehension. Med Sci Sports Exerc. 2015 Dec;47(12):2612-20. doi: 10.1249/MSS.0000000000000726.</citation>
    <PMID>26110696</PMID>
  </results_reference>
  <results_reference>
    <citation>Jensen KU, Bongaerts G, Bruhn R, Schneider S. Not all Rowe scores are the same! Which Rowe score do you use? J Shoulder Elbow Surg. 2009 Jul-Aug;18(4):511-4. doi: 10.1016/j.jse.2009.02.003.</citation>
    <PMID>19559368</PMID>
  </results_reference>
  <results_reference>
    <citation>Bessiere C, Trojani C, Pelegri C, Carles M, Boileau P. Coracoid bone block versus arthroscopic Bankart repair: a comparative paired study with 5-year follow-up. Orthop Traumatol Surg Res. 2013 Apr;99(2):123-30. doi: 10.1016/j.otsr.2012.12.010. Epub 2013 Mar 6.</citation>
    <PMID>23481699</PMID>
  </results_reference>
  <results_reference>
    <citation>Roulet S, Borel F, Franger G, Liotard JP, Michelet A, Godeneche A. Immediate self-rehabilitation after open Latarjet procedures enables recovery of preoperative shoulder mobility at 3 months. Knee Surg Sports Traumatol Arthrosc. 2019 Dec;27(12):3979-3988. doi: 10.1007/s00167-019-05635-8. Epub 2019 Jul 25.</citation>
    <PMID>31346667</PMID>
  </results_reference>
  <results_reference>
    <citation>Burkhart SS, De Beer JF, Barth JR, Cresswell T, Roberts C, Richards DP. Results of modified Latarjet reconstruction in patients with anteroinferior instability and significant bone loss. Arthroscopy. 2007 Oct;23(10):1033-41. doi: 10.1016/j.arthro.2007.08.009. Erratum In: Arthroscopy. 2007 Dec;23(12):A16. Criswell, Tim [corrected to Cresswell,Tim].</citation>
    <PMID>17916467</PMID>
  </results_reference>
  <results_reference>
    <citation>Park I, Oh MJ, Shin SJ. Minimal Clinically Important Differences and Correlating Factors for the Rowe Score and the American Shoulder and Elbow Surgeons Score After Arthroscopic Stabilization Surgery for Anterior Shoulder Instability. Arthroscopy. 2019 Jan;35(1):54-59. doi: 10.1016/j.arthro.2018.08.005.</citation>
    <PMID>30611364</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>La Tour Hospital</investigator_affiliation>
    <investigator_full_name>Hugo Bothorel</investigator_full_name>
    <investigator_title>Clinical trial supervisor LaTour Hospital</investigator_title>
  </responsible_party>
  <keyword>Latarjet</keyword>
  <keyword>Post operative</keyword>
  <keyword>Sling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Dislocation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04479397
org study id: 2019-02469
nct id: NCT04479397
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Traumatic anterior shoulder instability is a common injury for the contact athlete, with high
      rates of recurrence in some athletic populations. The specific indication for the Latarjet
      procedure differs amongst surgeons, however it is generally accepted that it is indicated in
      patients with anterior glenohumeral instability that are unlikely to have a successful
      outcome from either an arthroscopic or open anatomical Bankart repair.

      Overall the rate of reoperation following a Latarjet is around 5-7%. Infection, hematoma as
      well as screw removal and glenoid bony rim fractures are the most common indications for
      reoperation. The rate of instability after a Latarjet is low, with 1.7%-5.0% rate of
      dislocation.

      However, in terms of rehabilitation, there are only a few studies and evidence of best
      practices. A recent review of the literature has highlighted four studies, comparing
      different rehabilitation protocols, which include different immobilization periods ranging
      from 0 to 3 weeks, and different types of mobilization (under physiotherapist supervision or
      not, with machine or not). They found a similar rate of recurrent dislocation between the
      different protocols. But early passive motion enables to improve the range of motion during
      first 3-6 months, with similar results at one year.

      One main aspect which the surgeon can influence is immobilization time. In all
      above-mentioned studies, patients had to wear a sling for at least 3 weeks, even in the early
      mobilization groups. Short protocols with encouraging results have been recently emphasized
      by in other fields of shoulder surgery. The investigators would like to determine if the
      absence of postoperative immobilization could lead to improved function and better range of
      motion. To the investigators best knowledge, no study has sought to compare the usefulness of
      sling wearing after Latarjet procedure. Avoiding the sling could simplify rehabilitation and
      should provide a return to normal function faster.
The aim of this study is to compare rehabilitation with the wearing of a sling, to
      rehabilitation without any immobilization after Latarjet procedure for treatment of anterior
      shoulder instability. Ultimately, the goal would be to offer to patients a simplified
      rehabilitation management, with a faster recovery, less pain and a quicker return to
      activities of daily living, work and sport.

      As primary outcome, investigators will evaluate if the Rowe score is superior without
      postoperative immobilization (without a sling during the first 3 weeks) at 6 months after
      surgery compared to sling wearing.

      Secondary outcomes include radiological criteria (X-rays and computed tomography (CT) at 6
      months for bony union), return to sport, work absenteeism, other complication rate
      (especially redislocation), and the undermentioned subjective and clinical scores before
      surgery and at 1.5, 6 and 12 postoperative months.

      All patients will be assessed with commonly used subjective scores in the form of
      self-administered questionnaires. The Visual Analog Scale (VAS) is a widely used single-item
      test where a patient rates pain intensity between 0 and 10. This scale is useful for patient
      preoperative and postoperative monitoring and has also been correlated with patient pain,
      anxiety and apprehension. Patient satisfaction (are patients satisfied, yes/no) will be
      assessed as well. Subjective Shoulder Value (SSV) is a single-question test where a patient
      is asked to rate his overall shoulder function as a percentage of normal shoulder. It is a
      quick and easily administered score that has also been validated for various shoulder
      disabilities, such as instability.

      The following clinical scores will be analyzed as well Rowe score for instability is a
      three-item test with four choices each, measuring shoulder function, stability, and motion.
      The final result is converted into a value between 0 and 100. These scores have been
      specifically developed for shoulder instability.

      Except for VAS, higher results mean higher function. ROM will be determined using a Vicon
      motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling
      at 120 Hz already available in our facility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rowe score
time frame: 12 postoperative months
description: The Rowe Score consists of a total of 100 points divided into three domains: (1) stability, which corresponds to a total 50 points; (2) mobility, which corresponds to 20 points; (3) function, which corresponds to 30 points.
measure: The Visual Analog Scale (VAS)
time frame: 12 postoperative months
description: The Visual Analog Scale (VAS) is a widely used single-item test where a patient rates pain intensity between 0 and 10. This scale is useful for patient preoperative and postoperative monitoring and has also been correlated with patient pain, anxiety and apprehension.
measure: Subjective Shoulder Value (SSV)
time frame: 12 postoperative months
description: The SSV is defined as a patient's subjective shoulder assessment expressed as a percent- age of an entirely normal shoulder, which would score 100%.
measure: Patient satisfaction
time frame: 12 postoperative months
description: Patients will be asked "are you satisfied, yes/no"
measure: Bony union
time frame: 12 postoperative months
description: Will be evaluated using a CT scan and/or X-ray
measure: Return to work
time frame: 12 postoperative months
description: Time, in days, till patients return to work
measure: Return to sport
time frame: 12 postoperative months
description: Time, in days, untill patients return to sports
measure: Redislocation
time frame: 12 postoperative months
description: Did the shoulder redislocate postoperatively, yes or no
measure: Range of motion
time frame: 12 postoperative months
description: ROM will be determined using a Vicon motion capture system (Vicon, Oxford Metrics, Oxford, UK) consisting of six cameras sampling at 120 Hz already available in our facility.
arm group label: Sling Arm
arm group type: Active Comparator
description: This arm of the study will receive a sling for 3 weeks in postoperative care.
arm group label: No Sling Arm
arm group type: Experimental
description: This arm of the study will not receive a sling during the postoperative care,
intervention type: Procedure
intervention name: Latarjet Surgery for anterior shoulder instability
description: Bone block procedure for anterior shoulder instability
arm group label: No Sling Arm
arm group label: Sling Arm
intervention type: Procedure
intervention name: No sling in postoperative care
description: No sling will be used in postoperative care.
arm group label: No Sling Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexandre Lädermann, PD Dr
phone: +41227197555
email: alexandre.laedermann@latour.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
citation: Griesser MJ, Harris JD, McCoy BW, Hussain WM, Jones MH, Bishop JY, Miniaci A. Complications and re-operations after Bristow-Latarjet shoulder stabilization: a systematic review. J Shoulder Elbow Surg. 2013 Feb;22(2):286-92. doi: 10.1016/j.jse.2012.09.009.
PMID: 23352473
citation: Whitehouse T, Orr R, Fitzgerald E, Harries S, McLellan CP. The Epidemiology of Injuries in Australian Professional Rugby Union 2014 Super Rugby Competition. Orthop J Sports Med. 2016 Mar 22;4(3):2325967116634075. doi: 10.1177/2325967116634075. eCollection 2016 Mar.
PMID: 27069947
citation: van der Linde JA, van Wijngaarden R, Somford MP, van Deurzen DF, van den Bekerom MP. The Bristow-Latarjet procedure, a historical note on a technique in comeback. Knee Surg Sports Traumatol Arthrosc. 2016 Feb;24(2):470-8. doi: 10.1007/s00167-015-3704-7. Epub 2015 Aug 1.
PMID: 26231148
citation: An VV, Sivakumar BS, Phan K, Trantalis J. A systematic review and meta-analysis of clinical and patient-reported outcomes following two procedures for recurrent traumatic anterior instability of the shoulder: Latarjet procedure vs. Bankart repair. J Shoulder Elbow Surg. 2016 May;25(5):853-63. doi: 10.1016/j.jse.2015.11.001. Epub 2016 Jan 19.
PMID: 26809355
citation: Cunningham G, Ladermann A. Redefining anterior shoulder impingement: a literature review. Int Orthop. 2018 Feb;42(2):359-366. doi: 10.1007/s00264-017-3515-1. Epub 2017 Jun 6.
PMID: 28585076
citation: Ma R, Brimmo OA, Li X, Colbert L. Current Concepts in Rehabilitation for Traumatic Anterior Shoulder Instability. Curr Rev Musculoskelet Med. 2017 Dec;10(4):499-506. doi: 10.1007/s12178-017-9449-9.
PMID: 29038953
citation: Ialenti MN, Mulvihill JD, Feinstein M, Zhang AL, Feeley BT. Return to Play Following Shoulder Stabilization: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2017 Sep 14;5(9):2325967117726055. doi: 10.1177/2325967117726055. eCollection 2017 Sep.
PMID: 28944249
citation: Young AA, Maia R, Berhouet J, Walch G. Open Latarjet procedure for management of bone loss in anterior instability of the glenohumeral joint. J Shoulder Elbow Surg. 2011 Mar;20(2 Suppl):S61-9. doi: 10.1016/j.jse.2010.07.022. Epub 2010 Dec 9. No abstract available.
PMID: 21145262
citation: Ladermann A, Lubbeke A, Stern R, Cunningham G, Bellotti V, Gazielly DF. Risk factors for dislocation arthropathy after Latarjet procedure: a long-term study. Int Orthop. 2013 Jun;37(6):1093-8. doi: 10.1007/s00264-013-1848-y. Epub 2013 Mar 13.
PMID: 23508865
citation: Cunningham G, Benchouk S, Kherad O, Ladermann A. Comparison of arthroscopic and open Latarjet with a learning curve analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Feb;24(2):540-5. doi: 10.1007/s00167-015-3910-3. Epub 2015 Dec 12.
PMID: 26658571
citation: Tirefort J, Schwitzguebel AJ, Collin P, Nowak A, Plomb-Holmes C, Ladermann A. Postoperative Mobilization After Superior Rotator Cuff Repair: Sling Versus No Sling: A Randomized Prospective Study. J Bone Joint Surg Am. 2019 Mar 20;101(6):494-503. doi: 10.2106/JBJS.18.00773.
PMID: 30893230
citation: Domos P, Lunini E, Ascione F, Serra N, Bercik MJ, Neyton L, Godeneche A, Walch G. Clinical and radiographic outcomes of open Latarjet procedure in patients aged 40 years or older. J Shoulder Elbow Surg. 2019 Sep;28(9):e304-e312. doi: 10.1016/j.jse.2019.02.004. Epub 2019 Apr 28.
PMID: 31043350
citation: Boileau P, Saliken D, Gendre P, Seeto BL, d'Ollonne T, Gonzalez JF, Bronsard N. Arthroscopic Latarjet: Suture-Button Fixation Is a Safe and Reliable Alternative to Screw Fixation. Arthroscopy. 2019 Apr;35(4):1050-1061. doi: 10.1016/j.arthro.2018.11.012. Epub 2019 Mar 8.
PMID: 30857907
citation: Gilbart MK, Gerber C. Comparison of the subjective shoulder value and the Constant score. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):717-21. doi: 10.1016/j.jse.2007.02.123.
PMID: 18061114
citation: Martinez-Urrutia A. Anxiety and pain in surgical patients. J Consult Clin Psychol. 1975 Aug;43(4):437-42. doi: 10.1037/h0076898. No abstract available.
PMID: 1159142
citation: Cunningham G, Zanchi D, Emmert K, Kopel R, Van De Ville D, Ladermann A, Haller S, Hoffmeyer P. Neural Correlates of Clinical Scores in Patients with Anterior Shoulder Apprehension. Med Sci Sports Exerc. 2015 Dec;47(12):2612-20. doi: 10.1249/MSS.0000000000000726.
PMID: 26110696
citation: Jensen KU, Bongaerts G, Bruhn R, Schneider S. Not all Rowe scores are the same! Which Rowe score do you use? J Shoulder Elbow Surg. 2009 Jul-Aug;18(4):511-4. doi: 10.1016/j.jse.2009.02.003.
PMID: 19559368
citation: Bessiere C, Trojani C, Pelegri C, Carles M, Boileau P. Coracoid bone block versus arthroscopic Bankart repair: a comparative paired study with 5-year follow-up. Orthop Traumatol Surg Res. 2013 Apr;99(2):123-30. doi: 10.1016/j.otsr.2012.12.010. Epub 2013 Mar 6.
PMID: 23481699
citation: Roulet S, Borel F, Franger G, Liotard JP, Michelet A, Godeneche A. Immediate self-rehabilitation after open Latarjet procedures enables recovery of preoperative shoulder mobility at 3 months. Knee Surg Sports Traumatol Arthrosc. 2019 Dec;27(12):3979-3988. doi: 10.1007/s00167-019-05635-8. Epub 2019 Jul 25.
PMID: 31346667
citation: Burkhart SS, De Beer JF, Barth JR, Cresswell T, Roberts C, Richards DP. Results of modified Latarjet reconstruction in patients with anteroinferior instability and significant bone loss. Arthroscopy. 2007 Oct;23(10):1033-41. doi: 10.1016/j.arthro.2007.08.009. Erratum In: Arthroscopy. 2007 Dec;23(12):A16. Criswell, Tim [corrected to Cresswell,Tim].
PMID: 17916467
citation: Park I, Oh MJ, Shin SJ. Minimal Clinically Important Differences and Correlating Factors for the Rowe Score and the American Shoulder and Elbow Surgeons Score After Arthroscopic Stabilization Surgery for Anterior Shoulder Instability. Arthroscopy. 2019 Jan;35(1):54-59. doi: 10.1016/j.arthro.2018.08.005.
PMID: 30611364
responsible party type: Sponsor-Investigator
investigator affiliation: La Tour Hospital
investigator full name: Hugo Bothorel
investigator title: Clinical trial supervisor LaTour Hospital
mesh term: Shoulder Dislocation
sharing ipd: Undecided