<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/NCT02980367</url>
  </required_header>
  <id_info>
    <org_study_id>12096</org_study_id>
    <nct_id>NCT02980367</nct_id>
  </id_info>
  <brief_title>ACL SNNAP Trial: ACL Surgery Necessity in Non Acute Patients</brief_title>
  <acronym>ACL SNNAP</acronym>
  <official_title>Comparison of the Clinical and Cost Effectiveness of Two Management Strategies for Non-acute Anterior Cruciate Ligament (ACL) Injury: Rehabilitation Versus Surgical Reconstruction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine in patients with non-acute Anterior&#xD;
      Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management&#xD;
      [Rehabilitation] (with option for later ACL reconstruction, only if required) is more&#xD;
      clinically effective and cost effective than a strategy of surgical management&#xD;
      [Reconstruction].&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ACL SNNAP study is a pragmatic multi-centre randomised controlled trial with two-arm&#xD;
      parallel groups and 1:1 allocation ratio to compare non-surgical management (Rehabilitation)&#xD;
      and surgical management (Reconstruction) options for patients with a symptomatic non-acute&#xD;
      ACL deficient knee.&#xD;
&#xD;
      The objective is to determine, in patients with non-acute Anterior Cruciate Ligament&#xD;
      Deficiency (ACLD), whether non-surgical treatment (with the option for later ACL&#xD;
      reconstruction if required) is more effective than surgical ACL reconstruction (as measured&#xD;
      by the Knee Injury and Osteoarthritis Outcome Score [KOOS4] at 18 months from randomisation).&#xD;
&#xD;
      Target sample size is 320 patients recruited from approx. 30 NHS orthopaedic units.&#xD;
&#xD;
      An internal pilot will be conducted with clear progression criteria regarding recruitment.&#xD;
&#xD;
      Both interventions are routine NHS treatments. Intervention content is based on a minimal set&#xD;
      of pre-established criteria in order to ensure the integrity of the comparison while allowing&#xD;
      for varying in practice in delivering the interventions between both surgeons and&#xD;
      physiotherapists. This largely pragmatic approach will allow clinical management to reflect&#xD;
      current practice and resource use within the NHS thus aiding generalisation.&#xD;
&#xD;
      Other than the allocated intervention, both groups will be followed-up in the same way to&#xD;
      exclude bias. Follow up for study purposes will be by patient self-reported questionnaire&#xD;
      completed using an electronic data capture collection system (a postal option will also be&#xD;
      available). The questionnaire will include the outcomes indicated in section 4 and will be&#xD;
      completed by participants at baseline, 6, 12 and 18 months. Non-response will be minimised&#xD;
      through use of multiple reminders such as web based, phone and text.&#xD;
&#xD;
      Neither participants nor health care practitioners (surgeons and physiotherapists) can be&#xD;
      blinded to receipt of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>Knee Injury and Osteoarthritis Outcome Score (KOOS4)</measure>
    <time_frame>18 months post randomisation</time_frame>
    <description>The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>At baseline and at 6, 12 and 18 months post randomisation</time_frame>
    <description>All 5 subscales of the KOOS will be included (the fifth scale being activities of daily living).&#xD;
Anterior Cruciate Ligament Quality of Life Score (ACL-QOL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Tegner scale</measure>
    <time_frame>At baseline and at 6, 12 and 18 months post randomisation</time_frame>
    <description>Activity level will be assessed using the Modified Tegner scale, graded from 1 (low activity levels) to 10 (professional level).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention related complications</measure>
    <time_frame>At 6, 12 and 18 months post randomisation</time_frame>
    <description>Any complications associated with undergoing ACL deficiency treatment will be recorded. This includes; for surgery group; re-admission, delayed hospital discharge, infection, unexpected poor range of movement (stiffness), excess bleeding, continued swelling, episodes of giving way, continued feeling of instability. For non-surgical group; continued swelling, episodes of giving way.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol EQ-5D-5L</measure>
    <time_frame>At baseline and at 6, 12 and 18 months post randomisation</time_frame>
    <description>Generic quality of life (self-reported outcome measure covering 5 health domains and used to facilitate the calculation of Quality Adjusted Life Years in health economic evaluations).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resource-usage data</measure>
    <time_frame>18 months post randomisation</time_frame>
    <description>Detailed resource use data on initial treatments received (surgical reconstruction or rehabilitation) and on subsequent healthcare contacts including re-operations (surgery arm), subsequent surgical reconstructions (rehabilitation arm), surgery-related complications, further rehabilitation, and primary care and other secondary care contacts out to 18 months post-randomisation. In addition, data will be collected on ability to work (e.g. sickness absences/return to work number of days off work and subjective working ability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anterior Cruciate Ligament Quality of Life score (ACL-QOL)</measure>
    <time_frame>At baseline and at 6, 12 and 18 months post randomisation</time_frame>
    <description>Expectations of return to activity and confidence in relation to the knee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>At baseline and at 6, 12 and 18 months post randomisation</time_frame>
    <description>Simple Likert scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Anterior Cruciate Ligament Injury</condition>
  <arm_group>
    <arm_group_label>ACL Rehabilitation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-surgical management [Rehabilitation] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ACL Reconstruction Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Surgical Management (Rehabilitation)</intervention_name>
    <description>Routine ACL rehabilitation protocols used at the participating site will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.</description>
    <arm_group_label>ACL Rehabilitation Group</arm_group_label>
    <other_name>Physical Therapy</other_name>
    <other_name>Physiotherapy</other_name>
    <other_name>Conservative Rehabilitation</other_name>
    <other_name>Conservative Management</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Management (Reconstruction)</intervention_name>
    <description>All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon's preference. All other care will be routine, including immediate post-operative care.</description>
    <arm_group_label>ACL Reconstruction Group</arm_group_label>
    <other_name>ACL Reconstruction</other_name>
    <other_name>ACLR</other_name>
    <other_name>ACL surgery</other_name>
    <other_name>Anterior Cruciate Ligament Surgery</other_name>
    <other_name>Surgical Management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is willing and able to give informed consent for participation in the&#xD;
             study.&#xD;
&#xD;
          -  Male or Female, aged 18 years or above.&#xD;
&#xD;
          -  Symptomatic ACL deficiency of the native ligament1 (instability-episodes of frank&#xD;
             giving way or feeling unstable) with ACL deficiency (either partial or complete tear)&#xD;
             confirmed using clinical assessment and MRI scan.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute phase of primary ACL injury i.e. not recovered from any acute symptoms relating&#xD;
             to their initial ACL injury.&#xD;
&#xD;
          -  Previous knee surgery (other than diagnostic arthroscopy or partial meniscectomy) to&#xD;
             index knee concomitant severe injury to contra-lateral knee.&#xD;
&#xD;
          -  Meniscal pathology with characteristics that indicate immediate surgery i.e. locked&#xD;
             knee, large bucket handle or complex cartilage tear producing mechanical symptoms.&#xD;
&#xD;
          -  Knee joint status of grade 3 or 4 on the Kellgren and Lawrence scale,&#xD;
&#xD;
          -  Grade 3 MCL/LCL injury, associated PCL/PLC injury&#xD;
&#xD;
          -  Inflammatory arthropathy.&#xD;
&#xD;
          -  Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Beard, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oxford</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Beard</last_name>
    <phone>01865 737210</phone>
    <email>ACL_SNNAP@ndorms.ox.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Loretta Davies</last_name>
    <phone>01865737210</phone>
    <email>loretta.davies@ndorms.ox.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Betsi Cadwaladr University Health Board</name>
      <address>
        <city>Bangor</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Basildon and Thurrock University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Basildon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sean Symons</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>North Bristol NHS Trust</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Murray</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Gloucestershire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cheltenham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Countess of Chester Hospital NHS Foundation Trust</name>
      <address>
        <city>Chester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Raghuram Thonse</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospitals Coventry and Warwickshire NHS Trust</name>
      <address>
        <city>Coventry</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Frimley Health NHS Foundation Trust</name>
      <address>
        <city>Frimley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospitals NHS Foundation Trust</name>
      <address>
        <city>Guildford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oliver Templeton-Ward</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hull and East Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Hull</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reza Mayahi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust</name>
      <address>
        <city>Leeds</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Leicester</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kings College Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barry Andrews</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Manchester University NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pankaj Sharma</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>North West Anglia NHS Foundation Trust</name>
      <address>
        <city>Peterborough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Portsmouth Hospitals NHS Trust</name>
      <address>
        <city>Portsmouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jeremy Rushbrook</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Berkshire NHS Foundation Trust</name>
      <address>
        <city>Reading</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Salisbury NHS Foundation Trust</name>
      <address>
        <city>Salisbury</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Leonidas Vachtsevanos</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Frimley Health NHS Foundation Trust</name>
      <address>
        <city>Slough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Stockport NHS Foundation Trust</name>
      <address>
        <city>Stockport</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Johnson</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sherwood Forest Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sutton In Ashfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Abertawe Bro Morannwg University Health Board</name>
      <address>
        <city>Swansea</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Great Western Hospitals NHS Foundation Trust</name>
      <address>
        <city>Swindon</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Taunton and Somerset NHS Foundation Trust</name>
      <address>
        <city>Taunton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Kelly</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Cornwall Hospitals NHS Trust</name>
      <address>
        <city>Truro</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robin Kincaid</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Mid Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Wakefield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jon Smith</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Warrington and Halton Hospitals NHS Foundation Trust</name>
      <address>
        <city>Warrington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wrightington, Wigan and Leigh NHS Foundation Trust</name>
      <address>
        <city>Wigan</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ben Coupe</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Betsi Cadwaladr University Health Board</name>
      <address>
        <city>Wrexham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yeogesh Joshi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yeovil District Hospital NHS Foundation Trust</name>
      <address>
        <city>Yeovil</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://snnap.octru.ox.ac.uk/</url>
    <description>ACL SNNAP Trial website</description>
  </link>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>October 14, 2021</last_update_submitted>
  <last_update_submitted_qc>October 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anterior Cruciate Ligament</keyword>
  <keyword>ACL</keyword>
  <keyword>Anterior Cruciate Ligament deficiency</keyword>
  <keyword>ACL deficiency</keyword>
  <keyword>ACLD</keyword>
  <keyword>Anterior Cruciate Ligament reconstruction</keyword>
  <keyword>ACL reconstruction</keyword>
  <keyword>Anterior Cruciate Ligament physiotherapy</keyword>
  <keyword>Anterior Cruciate Ligament rehabilitation</keyword>
  <keyword>ACL physiotherapy</keyword>
  <keyword>ACL rehabilitation</keyword>
  <keyword>Anterior Cruciate Ligament management</keyword>
  <keyword>ACL management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anterior Cruciate Ligament Injuries</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/NCT02980367
org study id: 12096
nct id: NCT02980367
lead sponsor: 
has dmc: Yes
The primary objective of this study is to determine in patients with non-acute Anterior
      Cruciate Ligament Deficiency (ACLD) whether a strategy of non-surgical management
      [Rehabilitation] (with option for later ACL reconstruction, only if required) is more
      clinically effective and cost effective than a strategy of surgical management
      [Reconstruction].
The ACL SNNAP study is a pragmatic multi-centre randomised controlled trial with two-arm
      parallel groups and 1:1 allocation ratio to compare non-surgical management (Rehabilitation)
      and surgical management (Reconstruction) options for patients with a symptomatic non-acute
      ACL deficient knee.

      The objective is to determine, in patients with non-acute Anterior Cruciate Ligament
      Deficiency (ACLD), whether non-surgical treatment (with the option for later ACL
      reconstruction if required) is more effective than surgical ACL reconstruction (as measured
      by the Knee Injury and Osteoarthritis Outcome Score [KOOS4] at 18 months from randomisation).

      Target sample size is 320 patients recruited from approx. 30 NHS orthopaedic units.

      An internal pilot will be conducted with clear progression criteria regarding recruitment.

      Both interventions are routine NHS treatments. Intervention content is based on a minimal set
      of pre-established criteria in order to ensure the integrity of the comparison while allowing
      for varying in practice in delivering the interventions between both surgeons and
      physiotherapists. This largely pragmatic approach will allow clinical management to reflect
      current practice and resource use within the NHS thus aiding generalisation.

      Other than the allocated intervention, both groups will be followed-up in the same way to
      exclude bias. Follow up for study purposes will be by patient self-reported questionnaire
      completed using an electronic data capture collection system (a postal option will also be
      available). The questionnaire will include the outcomes indicated in section 4 and will be
      completed by participants at baseline, 6, 12 and 18 months. Non-response will be minimised
      through use of multiple reminders such as web based, phone and text.

      Neither participants nor health care practitioners (surgeons and physiotherapists) can be
      blinded to receipt of the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS4)
time frame: 18 months post randomisation
description: The score is derived from 4 of 5 subscales; pain, symptoms, difficulty in sports and recreational activities, knee related quality of life.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: At baseline and at 6, 12 and 18 months post randomisation
description: All 5 subscales of the KOOS will be included (the fifth scale being activities of daily living).
Anterior Cruciate Ligament Quality of Life Score (ACL-QOL)
measure: Modified Tegner scale
time frame: At baseline and at 6, 12 and 18 months post randomisation
description: Activity level will be assessed using the Modified Tegner scale, graded from 1 (low activity levels) to 10 (professional level).
measure: Intervention related complications
time frame: At 6, 12 and 18 months post randomisation
description: Any complications associated with undergoing ACL deficiency treatment will be recorded. This includes; for surgery group; re-admission, delayed hospital discharge, infection, unexpected poor range of movement (stiffness), excess bleeding, continued swelling, episodes of giving way, continued feeling of instability. For non-surgical group; continued swelling, episodes of giving way.
measure: EuroQol EQ-5D-5L
time frame: At baseline and at 6, 12 and 18 months post randomisation
description: Generic quality of life (self-reported outcome measure covering 5 health domains and used to facilitate the calculation of Quality Adjusted Life Years in health economic evaluations).
measure: Resource-usage data
time frame: 18 months post randomisation
description: Detailed resource use data on initial treatments received (surgical reconstruction or rehabilitation) and on subsequent healthcare contacts including re-operations (surgery arm), subsequent surgical reconstructions (rehabilitation arm), surgery-related complications, further rehabilitation, and primary care and other secondary care contacts out to 18 months post-randomisation. In addition, data will be collected on ability to work (e.g. sickness absences/return to work number of days off work and subjective working ability).
measure: Anterior Cruciate Ligament Quality of Life score (ACL-QOL)
time frame: At baseline and at 6, 12 and 18 months post randomisation
description: Expectations of return to activity and confidence in relation to the knee.
measure: Patient satisfaction
time frame: At baseline and at 6, 12 and 18 months post randomisation
description: Simple Likert scale
arm group label: ACL Rehabilitation Group
arm group type: Experimental
description: Non-surgical management [Rehabilitation] with option for later Anterior Cruciate Ligament (ACL) reconstruction, only if required.
arm group label: ACL Reconstruction Group
arm group type: Active Comparator
description: Surgical Management - Anterior Cruciate Ligament (ACL) reconstruction surgery
intervention type: Other
intervention name: Non-Surgical Management (Rehabilitation)
description: Routine ACL rehabilitation protocols used at the participating site will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.
arm group label: ACL Rehabilitation Group
other name: Physical Therapy
other name: Physiotherapy
other name: Conservative Rehabilitation
other name: Conservative Management
intervention type: Procedure
intervention name: Surgical Management (Reconstruction)
description: All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon's preference. All other care will be routine, including immediate post-operative care.
arm group label: ACL Reconstruction Group
other name: ACL Reconstruction
other name: ACLR
other name: ACL surgery
other name: Anterior Cruciate Ligament Surgery
other name: Surgical Management
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: David Beard, DPhil
role: Principal Investigator
affiliation: University of Oxford
last name: David Beard
phone: 01865 737210
email: ACL_SNNAP@ndorms.ox.ac.uk
last name: Loretta Davies
phone: 01865737210
email: loretta.davies@ndorms.ox.ac.uk
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country: United Kingdom
url: http://snnap.octru.ox.ac.uk/
description: ACL SNNAP Trial website
responsible party type: Sponsor
mesh term: Anterior Cruciate Ligament Injuries
sharing ipd: Undecided