<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/NCT04429165</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00551; ch20Rikli</org_study_id>
    <nct_id>NCT04429165</nct_id>
  </id_info>
  <brief_title>Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction</brief_title>
  <acronym>RetroBRACE II</acronym>
  <official_title>RetroBRACE II: Clinical and Functional Outcomes 2 Years After ACL Repair and InternalBrace Ligament Augmentation in Comparison With ACL Reconstruction - Considering Socioeconomic Aspects and Return to Work</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years&#xD;
      after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct&#xD;
      comparison to ACL reconstruction and to identify potential deficits compared to the&#xD;
      contralateral healthy side as well as with a knee-healthy age-matched collective. In&#xD;
      addition, socio-economic aspects such as return to work and sports and treatment cost will be&#xD;
      compared between both techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the&#xD;
      knee. Since May 2016, patients with proximal ruptures of the ACL have been treated with&#xD;
      direct repair and InternalBraceTM Ligament Augmentation at the University Hospital of Basel.&#xD;
&#xD;
      The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest&#xD;
      2 years after the surgery. The aim of this study is to assess the clinical, biomechanical and&#xD;
      functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM&#xD;
      augmentation now in direct comparison to ACL reconstruction and to identify potential&#xD;
      deficits compared to the contralateral healthy side as well as with a knee-healthy&#xD;
      age-matched collective. In addition, socio-economic aspects such as return to work and sports&#xD;
      and treatment cost will be compared between both techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2020</start_date>
  <completion_date type="Actual">July 14, 2022</completion_date>
  <primary_completion_date type="Actual">July 14, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Range of Motion (ROM) of the knee</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>Range of Motion (ROM) of the knee</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Isokinetic muscle strength</measure>
    <time_frame>approx. 30 minutes at baseline (2 years after surgery)</time_frame>
    <description>Isokinetic muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). The maximum isokinetic flexion and extension torques will be measured on the knee between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (15 repetitions). Maximum torques will be recorded for each direction of movement and normalized to body weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proprioception (joint position sense)</measure>
    <time_frame>approx. 30 minutes at baseline (2 years after surgery)</time_frame>
    <description>Proprioception will be measured bilaterally with a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA) using an active joint position sense protocol. The participants will be positioned on the dynamometer with knee and hip angles of 90°. They will then actively stretch their knees up to target angles of 60° or 30° flexion. Subjects will be asked to remember this position and then stretch their knees from a starting position of 90° flexion and, as soon as they think they have reached the target angle, push a stop button. The deviation between the perceived angle and the actual target angle will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gait analysis</measure>
    <time_frame>approx. 60 minutes at baseline (2 years after surgery)</time_frame>
    <description>Gait analysis performed on a treadmill with an integrated pressure plate and a walkway with two integrated force plates. Kinematic and EMG data collected using a 9-camera Vicon system and a 12-channel EMG system. To measure 3D joint angles, reflective markers will be attached to defined anatomical locations on the pelvis and legs.10 Bipolar surface electrodes will be attached bilaterally to the glutaeus medius, vastus medialis and lateralis, semitendinosus, tibialis anterior and gastrocnemius medialis muscles according to the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles). Study participants walk at self-selected speed. In addition, patients walk on treadmill at a self-selected speed, at a speed of 1.2 m/s and to run at self-selected speed and if possible at 2.2m/s. Kinematic and kinetic, EMG and pressure data recorded for all testing conditions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postural stability</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>The stability of posture and balancing will be determined by the variability of movement in the horizontal plane and the length of the pressure line during two 30-second single- leg stands (on solid surface and on foam surface) on a force plate (Kistler 9260AA6, Kistler AG, Winterthur, Switzerland; sampling frequency, 2400 Hz) and mathematical calculations</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional activity score to determine the ability &quot;return to activity&quot;</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>Functional activity tests include the Y-balance test, single-leg jump for distance, side jumps for time (30 seconds) and precision over a distance of 40 cm (side hop). The quantity of movement of these functional scores will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee Problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Knee Documentation Committee (IKDC)</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tegner Activity Score</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQoL-5D-5L (EQ 5D 5L)</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>EQ-5D-5L questionnaire measuring generic health Status; descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ACL- RSI Score</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>The ALC-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each. It is considered that for a normal population without knee condition, the score is between 80 and 90%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to work</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>Socioeconomic aspect: time to return to work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to sports</measure>
    <time_frame>at baseline (2 years after surgery)</time_frame>
    <description>Time to return to sports</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Injury of the Anterior Cruciate Ligament (ACL)</condition>
  <arm_group>
    <arm_group_label>ACL reconstruction</arm_group_label>
    <description>ACL reconstruction using an autologous hamstring tendon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>knee-healthy, age-matched subjects as a control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>collection of Patient Reported Outcome (PRO) data</intervention_name>
    <description>collection of Patient Reported Outcome (PRO) data by questionnaires</description>
    <arm_group_label>ACL reconstruction</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>collection of anthropometric and clinical functional data</intervention_name>
    <description>collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity</description>
    <arm_group_label>ACL reconstruction</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>gait analysis</intervention_name>
    <description>gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded</description>
    <arm_group_label>ACL reconstruction</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who underwent ACL reconstruction using an autologous hamstring tendon between&#xD;
        03/18 and 04/20 at University Hospital Basel.&#xD;
&#xD;
        30 age-matched control subjects without previous history of knee injury and/or surgery will&#xD;
        be included for comparison.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients: 2 years since ACL reconstruction with autologous hamstring tendon&#xD;
&#xD;
          -  Control subjects: no previous injury to the meniscus or the ligament apparatus of the&#xD;
             knee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 35 kg / m2&#xD;
&#xD;
          -  neuromuscular diseases that affect lower limb movement&#xD;
&#xD;
          -  Inability to give informed consent&#xD;
&#xD;
          -  Patients: previous injury or surgical treatment of the opposite side within the past 2&#xD;
             years and the injured leg within the past 6 months; other pathologies that affect the&#xD;
             mobility of the knee&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sebastian Mueller, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Orthopaedics and Traumatology, University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Orthopaedics and Traumatology, University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ACL rupture</keyword>
  <keyword>primary ACL repair</keyword>
  <keyword>ACL reconstruction using autologous hamstring tendons</keyword>
  <keyword>InternalBraceTM Ligament Augmentation</keyword>
  <!-- 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/NCT04429165
org study id: 2020-00551; ch20Rikli
nct id: NCT04429165
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the clinical, biomechanical and functional outcome 2 years
      after anterior cruciate ligament (ACL) repair and InternalBraceTM augmentation now in direct
      comparison to ACL reconstruction and to identify potential deficits compared to the
      contralateral healthy side as well as with a knee-healthy age-matched collective. In
      addition, socio-economic aspects such as return to work and sports and treatment cost will be
      compared between both techniques.
Injury of the anterior cruciate ligament (ACL) is one of the most common injuries of the
      knee. Since May 2016, patients with proximal ruptures of the ACL have been treated with
      direct repair and InternalBraceTM Ligament Augmentation at the University Hospital of Basel.

      The remodelling of hamstring grafts used for ACL reconstruction is completed at the earliest
      2 years after the surgery. The aim of this study is to assess the clinical, biomechanical and
      functional outcome 2 years after anterior cruciate ligament (ACL) repair and InternalBraceTM
      augmentation now in direct comparison to ACL reconstruction and to identify potential
      deficits compared to the contralateral healthy side as well as with a knee-healthy
      age-matched collective. In addition, socio-economic aspects such as return to work and sports
      and treatment cost will be compared between both techniques.
observational model: Case-Control
time perspective: Retrospective
measure: Range of Motion (ROM) of the knee
time frame: at baseline (2 years after surgery)
description: Range of Motion (ROM) of the knee
measure: Isokinetic muscle strength
time frame: approx. 30 minutes at baseline (2 years after surgery)
description: Isokinetic muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). The maximum isokinetic flexion and extension torques will be measured on the knee between full extension and 90° flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (15 repetitions). Maximum torques will be recorded for each direction of movement and normalized to body weight.
measure: Proprioception (joint position sense)
time frame: approx. 30 minutes at baseline (2 years after surgery)
description: Proprioception will be measured bilaterally with a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA) using an active joint position sense protocol. The participants will be positioned on the dynamometer with knee and hip angles of 90°. They will then actively stretch their knees up to target angles of 60° or 30° flexion. Subjects will be asked to remember this position and then stretch their knees from a starting position of 90° flexion and, as soon as they think they have reached the target angle, push a stop button. The deviation between the perceived angle and the actual target angle will be calculated.
measure: Gait analysis
time frame: approx. 60 minutes at baseline (2 years after surgery)
description: Gait analysis performed on a treadmill with an integrated pressure plate and a walkway with two integrated force plates. Kinematic and EMG data collected using a 9-camera Vicon system and a 12-channel EMG system. To measure 3D joint angles, reflective markers will be attached to defined anatomical locations on the pelvis and legs.10 Bipolar surface electrodes will be attached bilaterally to the glutaeus medius, vastus medialis and lateralis, semitendinosus, tibialis anterior and gastrocnemius medialis muscles according to the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles). Study participants walk at self-selected speed. In addition, patients walk on treadmill at a self-selected speed, at a speed of 1.2 m/s and to run at self-selected speed and if possible at 2.2m/s. Kinematic and kinetic, EMG and pressure data recorded for all testing conditions.
measure: Postural stability
time frame: at baseline (2 years after surgery)
description: The stability of posture and balancing will be determined by the variability of movement in the horizontal plane and the length of the pressure line during two 30-second single- leg stands (on solid surface and on foam surface) on a force plate (Kistler 9260AA6, Kistler AG, Winterthur, Switzerland; sampling frequency, 2400 Hz) and mathematical calculations
measure: Functional activity score to determine the ability "return to activity"
time frame: at baseline (2 years after surgery)
description: Functional activity tests include the Y-balance test, single-leg jump for distance, side jumps for time (30 seconds) and precision over a distance of 40 cm (side hop). The quantity of movement of these functional scores will be calculated.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: at baseline (2 years after surgery)
description: questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury. The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee Problems.
measure: International Knee Documentation Committee (IKDC)
time frame: at baseline (2 years after surgery)
description: The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee. Scores are obtained by summing the individual items, then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function
measure: Tegner Activity Score
time frame: at baseline (2 years after surgery)
description: Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
measure: EuroQoL-5D-5L (EQ 5D 5L)
time frame: at baseline (2 years after surgery)
description: EQ-5D-5L questionnaire measuring generic health Status; descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions).
measure: ACL- RSI Score
time frame: at baseline (2 years after surgery)
description: The ALC-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each. It is considered that for a normal population without knee condition, the score is between 80 and 90%
measure: Time to return to work
time frame: at baseline (2 years after surgery)
description: Socioeconomic aspect: time to return to work
measure: Time to return to sports
time frame: at baseline (2 years after surgery)
description: Time to return to sports
arm group label: ACL reconstruction
description: ACL reconstruction using an autologous hamstring tendon
arm group label: control group
description: knee-healthy, age-matched subjects as a control group
intervention type: Other
intervention name: collection of Patient Reported Outcome (PRO) data
description: collection of Patient Reported Outcome (PRO) data by questionnaires
arm group label: ACL reconstruction
arm group label: control group
intervention type: Other
intervention name: collection of anthropometric and clinical functional data
description: collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity
arm group label: ACL reconstruction
arm group label: control group
intervention type: Other
intervention name: gait analysis
description: gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded
arm group label: ACL reconstruction
arm group label: control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sebastian Mueller, Dr. med.
role: Principal Investigator
affiliation: Department of Orthopaedics and Traumatology, University Hospital Basel
facility: 
country: Switzerland
responsible party type: Sponsor