<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.134461.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Outcome analysis of posterior cruciate ligament injuries</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: 1 approved with reservations]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Suneja</surname>
                        <given-names>Anmol</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Project Administration</role>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Software</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0009-3117-4699</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Deshpande</surname>
                        <given-names>Sanjay</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Jadawala</surname>
                        <given-names>Vivek</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0000-0003-0163-9132</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Goel</surname>
                        <given-names>Sachin</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Resources</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <uri content-type="orcid">https://orcid.org/0009-0008-5297-2748</uri>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Orthopaedics, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:anmolsuneja12@gmail.com">anmolsuneja12@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>18</day>
                <month>7</month>
                <year>2023</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2023</year>
            </pub-date>
            <volume>12</volume>
            <elocation-id>842</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>11</day>
                    <month>7</month>
                    <year>2023</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Suneja A et al.</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/12-842/pdf"/>
            <abstract>
                <p>
                    <bold>Background</bold> - The posterior cruciate ligament (PCL), a major stabiliser of the knee, restrains the posterior translation of tibia over femur. Injury to the two bundles of this ligament is usually seen in a motor vehicle accident, followed by dashboard injury.</p>
                <p>
                    <bold>Methods</bold> - Non-operative management post posterior cruciate ligament tears includes non-steroidal anti-inflammatory drugs and rehabilitation. Common surgical procedures include trans-tibial tunnel or tibial inlay technique of graft reconstruction, single bundle or double bundle reconstruction. Literature on outcomes of posterior cruciate ligament injuries managed with either of the methods is sparse; we therefore aim to conduct an interventional study to analyse the patients&#x2019; functional status and satisfaction post treatment.</p>
                <p>
                    <bold>Conclusions</bold> - Lysholm knee scoring scale and IKDC knee scoring system will be used as outcome measures. The follow up scores are taken 6, 12, 15 and 24 months after the treatment.</p>
                <p>
                    <bold>CTRI registration</bold>: 
                    <ext-link ext-link-type="uri" xlink:href="https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=85729&amp;EncHid=18479.57820&amp;modid=&amp;compid=">REF/2023/06/068422</ext-link>
                </p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Posterior Cruciate Ligament</kwd>
                <kwd>Autologous Tendon Graft</kwd>
                <kwd>Posterior Drawer Test</kwd>
                <kwd>Outcome Analysis</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <sec id="sec2">
                <title>Background and rationale</title>
                <p>In the knee joint complex, cruciate ligaments are of great importance as they provide maximal restrain to the translation of tibia over the femur.
                    <sup>
                        <xref ref-type="bibr" rid="ref1">1</xref>
                    </sup> The posterior cruciate ligament with its attachment at the antero-lateral aspect of medial condyle of femur proximally and distally at the tibial plateau, gives primary restrain to posterior translation of tibia over femur.
                    <sup>
                        <xref ref-type="bibr" rid="ref2">2</xref>
                    </sup> It, to some extent, also works to resist the valgus and varus forces.
                    <sup>
                        <xref ref-type="bibr" rid="ref3">3</xref>
                    </sup> Injury to this ligament occurs less often than to the other cruciate ligament of the knee complex. It has a cross sectional area of 11-13 mm
                    <sup>2</sup>, making it twice as thick as the anterior cruciate ligament and a tensile strength of 739 to 1627 Newton.
                    <sup>
                        <xref ref-type="bibr" rid="ref4">4</xref>
                    </sup>
                </p>
                <p>A posteriorly directed strong force is required to damage both the postero-medial and antero-lateral bundles of the posterior cruciate ligament (PCL) and this usually occurs with knee in flexion.
                    <sup>
                        <xref ref-type="bibr" rid="ref5">5</xref>
                    </sup> Dashboard injuries following motor vehicle accidents are the most common causative factors.
                    <sup>
                        <xref ref-type="bibr" rid="ref6">6</xref>
                    </sup> Additionally, falling forward onto a flexed knee might result in PCL damage. In baseball, football, skiing and rugby, PCL injuries are the most frequent sports-related injuries. Less frequently, harm to the knee joint might result from a rotational hyperextension injury.
                    <sup>
                        <xref ref-type="bibr" rid="ref7">7</xref>
                    </sup>
                    <sup>,</sup>
                    <sup>
                        <xref ref-type="bibr" rid="ref8">8</xref>
                    </sup>
                </p>
                <p>Injury to this ligament accounts for only 20% of the ligament injuries of the knee. PCL sprains or tears usually occur with the involvement of other ligaments, making isolated PCL injuries a rare occurrence.
                    <sup>
                        <xref ref-type="bibr" rid="ref9">9</xref>
                    </sup> A study conducted in 2003 stated that motor vehicle accidents and sport injuries account for 45% and 40% of PCL injuries respectively, with the average age of receiving these injuries being 27 years old. Falls on a flexed knee with foot plantar flexed accounted for 24%.
                    <sup>
                        <xref ref-type="bibr" rid="ref10">10</xref>
                    </sup>
                    <sup>,</sup>
                    <sup>
                        <xref ref-type="bibr" rid="ref11">11</xref>
                    </sup>
                </p>
                <p>The ligament is further divided into two parts: the antero-lateral bundle, making up 65% of the ligament, and the postero-medial bundle, making up 35%.
                    <sup>
                        <xref ref-type="bibr" rid="ref12">12</xref>
                    </sup> The postero-medial bundle is taut with knee in extension and the anterolateral bundle is taut in knee flexion.
                    <sup>
                        <xref ref-type="bibr" rid="ref13">13</xref>
                    </sup> It provides greatest restrain between 30-90 degrees of knee flexion.
                    <sup>
                        <xref ref-type="bibr" rid="ref14">14</xref>
                    </sup> Since injuries to the flexion are more common, the anterolateral bundle is more susceptible to sprains and tears,
                    <sup>
                        <xref ref-type="bibr" rid="ref15">15</xref>
                    </sup> although literature on pure isolated injuries of the two bundles is scarce.
                    <sup>
                        <xref ref-type="bibr" rid="ref16">16</xref>
                    </sup> The middle geniculate artery supplies blood to the PCL, which also is innervated by the tibial nerve.
                    <sup>
                        <xref ref-type="bibr" rid="ref17">17</xref>
                    </sup> At 90 degrees, 95% of the posterior translational forces are absorbed by the PCL.
                    <sup>
                        <xref ref-type="bibr" rid="ref18">18</xref>
                    </sup> The postero-lateral joint capsule, popliteus, medial collateral ligament, and posterior oblique ligament also helps to prevent posterior translation of tibia over femur.
                    <sup>
                        <xref ref-type="bibr" rid="ref19">19</xref>
                    </sup>
                </p>
                <p>Management for grade I and II sprains where only a proportion of fibres are involved includes rehabilitation and non-steroidal anti-inflammatory drugs. Surgical treatment includes ligament reconstruction using either hamstring, peroneus or bone patellar tendon bone graft.
                    <sup>
                        <xref ref-type="bibr" rid="ref20">20</xref>
                    </sup>
                    <sup>&#x2013;</sup>
                    <sup>
                        <xref ref-type="bibr" rid="ref22">22</xref>
                    </sup>
                </p>
            </sec>
            <sec id="sec3">
                <title>Objectives</title>
                <p>The primary objective of the study is to assess the functional, clinical and radiological outcome of posterior cruciate ligament injuries managed surgically. The secondary objectives of the study are to study the aetiology of posterior cruciate ligament injuries, and to assess any complications associated with management modalities.</p>
            </sec>
        </sec>
        <sec id="sec4">
            <title>Protocol</title>
            <sec id="sec5">
                <title>Registration</title>
                <p>This trial has been registered with CTRI (
                    <ext-link ext-link-type="uri" xlink:href="https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=85729&amp;EncHid=18479.57820&amp;modid=&amp;compid=">REF/2023/06/068422</ext-link>).</p>
            </sec>
            <sec id="sec6">
                <title>Trial design</title>
                <p>This is a single group type of trial with participants being surgically managed for PCL injuries. The framework of the trial is superiority and exploratory. This is a hospital-based experimental study.</p>
            </sec>
            <sec id="sec7">
                <title>Participants</title>
                <p>The study will be conducted in Department of Orthopaedics, Jawaharlal Nehru Medical College (JNMC) and Acharya Vinoba Bhave Rural Hospital (AVBRH), Wardha, Maharashtra, India. Included in the study will be all skeletally matured patients of age 25 years and above, both male and female, with symptoms and traumatic PCL injuries planned for surgical management. Exclusion criteria will be patients with injuries to the PCL who will be managed conservatively, injuries to the PCL that have infectious foci, tumour conditions, osteoarthritic changes, and congenital and metabolic disorders.</p>
            </sec>
            <sec id="sec8">
                <title>Interventions</title>
                <p>A pre-intervention assessment will be done, taking detailed clinical history with assessment pro-forma, clinical examination, and radiological tests such as X-ray and magnetic resonance imaging, as well as all routine examination like complete blood count, liver function tests, kidney function test, random blood sugar, chest X-ray, electrocardiogram and with functional parameters. Pre-anaesthetic check-up, part preparation and physician fitness will be obtained for each patient. Arthroscopic PCL reconstruction with double-bundle graft
                    <sup>
                        <xref ref-type="bibr" rid="ref23">23</xref>
                    </sup> surgery will be performed, and the expected duration of the surgery will be two to three hours. Patients will be arranged supine on the operating table. Under all aseptic precautions and antibiotic prophylaxis, the site to be operated on will be prepared thoroughly keeping the knee joint in flexion. A tourniquet applied around the proximal thigh will be inflated. Arthroscopic portals will be placed and a scope inserted to visualise the PCL tear. Regarding the type of graft used (auto-graft), if the patient has a PCL avulsion fracture then interference cc screw will be used; if they have a single PCL injury then a hamstring graft, i.e. semitendinosus and semimembranosus graft will be used, and if they have a multi ligament injury then a peroneus tertius graft will be used. Similar considerations will be given to the anaesthesia used: if the participant has an avulsion and single ligament injury then spinal anaesthesia will be given, and if they have a multi ligament injury then spinal and epidural anaesthesia will be given. Arthroscopic tunnels will be positioned with graft in place using endobutton loop and fixed with interference screw or suture disc. A thorough wash will be given, closure to be done in layers with sterile dressing in situ and long knee brace
                    <sup>
                        <xref ref-type="bibr" rid="ref21">21</xref>
                    </sup> will be applied before moving the patient to the recovery ward for observation. Pre and intra-operative discontinuation or modifications will be considered as per the participant&#x2019;s request and possible improvement or worsening of their condition. Post-intervention, all assessments will be repeated using clinical examination, pro-forma, radiological findings and with functional parameters. Post-operatively Mass General Brigham rehabilitation protocol for PCL reconstruction will be followed. Clinical, radiological and functional results of PCL injuries will help to investigate the causes and to evaluate any problems related to treatment options and any complications associated with it. The participants enrolled in the study will be followed up for post-operative assessment at intervals of 1 month, 3 months, 6 months and then 2 years.</p>
            </sec>
            <sec id="sec9">
                <title>Outcomes</title>
                <p>Primary outcome measures
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Lysholm knee scoring scale
                                <sup>
                                    <xref ref-type="bibr" rid="ref24">24</xref>
                                </sup> (
                                <xref ref-type="fig" rid="f1">Figure 1</xref>)</p>
                            <p>This will be administrated to evaluate functional status, specifically instability post knee ligament surgeries. It consists of eight items: limp, support, locking, pain, and swelling, instability, climbing stairs and squatting. An arbitrary score with a decreasing value for each item is given. The sum of each score for the 8 items is recorded. A maximum possible score of 100 indicates no symptom and disability and a score of less than 64 indicates poor status.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>IKDC knee scoring system
                                <sup>
                                    <xref ref-type="bibr" rid="ref25">25</xref>
                                </sup> (
                                <xref ref-type="fig" rid="f2">Figure 2</xref>)</p>
                            <p>This is a knee specific, patient reported outcome measure that assesses an individual&#x2019;s knee related symptoms (7 items), functions (2 items) and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).</p>
                        </list-item>
                    </list>
                </p>
                <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                    <label>Figure 1. </label>
                    <caption>
                        <title>Lysholm knee scoring scale.</title>
                    </caption>
                    <graphic id="gr1" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/147519/23df20e1-62e0-4bc8-965b-b4a717c2dd17_figure1.gif"/>
                </fig>
                <fig fig-type="figure" id="f2" orientation="portrait" position="float">
                    <label>Figure 2. </label>
                    <caption>
                        <title>IKDC knee scoring system.</title>
                    </caption>
                    <graphic id="gr2" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/147519/23df20e1-62e0-4bc8-965b-b4a717c2dd17_figure2.gif"/>
                </fig>
                <p>Secondary outcome measures
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Visual examination</p>
                            <p>This includes gait examination, instability and any abnormal swelling. Additionally, the Sag test will be conducted to compare the affected and non-affected side.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>Muscular strength and range of motion</p>
                            <p>Muscle strength and range of motion assessment will be done using a muscle strength grading system, and range of motion assessment will be done using a goniometer assessment.</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>Additional tests</p>
                            <p>These include scoring and measurements from the posterior drawer test, varus and valgus tests, and dial test.</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>Radiological findings</p>
                            <p>These include X-ray and MRI of the knee joint.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec10">
                <title>Sample size</title>
                <p>The sample size formula (Daniel, 1999) is used,
                    <sup>
                        <xref ref-type="bibr" rid="ref26">26</xref>
                    </sup> which is
                    <disp-formula id="e1">
                        <mml:math display="block">
                            <mml:mi mathvariant="normal">n</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:msup>
                                <mml:mi mathvariant="normal">Z</mml:mi>
                                <mml:mn>2</mml:mn>
                            </mml:msup>
                            <mml:mspace width="0.25em"/>
                            <mml:mi mathvariant="normal">P</mml:mi>
                            <mml:mfenced close=")" open="(">
                                <mml:mrow>
                                    <mml:mn>1</mml:mn>
                                    <mml:mo>&#x2212;</mml:mo>
                                    <mml:mi mathvariant="normal">P</mml:mi>
                                </mml:mrow>
                            </mml:mfenced>
                            <mml:mo>/</mml:mo>
                            <mml:msup>
                                <mml:mi mathvariant="normal">d</mml:mi>
                                <mml:mn>2</mml:mn>
                            </mml:msup>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>If the population is more than 10,000 where,</p>
                <p>Z = statistic for a level of confidence. (For the level of confidence of 95%, which is conventional, Z value is 1.96).</p>
                <p>P = expected prevalence or proportion i.e. prevalence of PCL injuries in India = 2.76% = 0.0276.
                    <sup>
                        <xref ref-type="bibr" rid="ref27">27</xref>
                    </sup>
                </p>
                <p>d = precision or desired error of margin = 7% = 0.07
                    <disp-formula id="e2">
                        <mml:math display="block">
                            <mml:mi mathvariant="normal">n</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:mfrac>
                                <mml:mrow>
                                    <mml:msup>
                                        <mml:mn>1.96</mml:mn>
                                        <mml:mrow>
                                            <mml:mn>2</mml:mn>
                                            <mml:mo>&#x2217;</mml:mo>
                                        </mml:mrow>
                                    </mml:msup>
                                    <mml:msup>
                                        <mml:mn>0.0276</mml:mn>
                                        <mml:mo>&#x2217;</mml:mo>
                                    </mml:msup>
                                    <mml:mfenced close=")" open="(">
                                        <mml:mrow>
                                            <mml:mn>1</mml:mn>
                                            <mml:mo>&#x2212;</mml:mo>
                                            <mml:mn>0.0276</mml:mn>
                                        </mml:mrow>
                                    </mml:mfenced>
                                </mml:mrow>
                                <mml:msup>
                                    <mml:mn>0.07</mml:mn>
                                    <mml:mn>2</mml:mn>
                                </mml:msup>
                            </mml:mfrac>
                            <mml:mo>=</mml:mo>
                            <mml:mn>21.04</mml:mn>
                            <mml:mo>=</mml:mo>
                            <mml:mn>25</mml:mn>
                            <mml:mspace width="0.12em"/>
                            <mml:mtext>patients&#x2009;needed&#x2009;in&#x2009;the&#x2009;study</mml:mtext>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>Statistical methods: Student&#x2019;s t-test, one way ANOVA and Pearson&#x2019;s correlation coefficient.</p>
            </sec>
            <sec id="sec11">
                <title>Data collection, management and analysis</title>
                <p>A total of 25 participants will be enrolled in the study who meet the inclusion criteria. All the participants will be educated about the purpose of the research, will then undergo the pre-study assessment and will complete clinical and radiological tests as described above. They will also undergo the Lysholm knee scoring scale and the IKDC knee scoring system, and the baseline data will be noted for each participant. The participants will be followed up for a minimum of 6 months and a maximum of 2 years from the treatment, as is suitable for the patient and the researcher. On every follow up, complications, if any, will be noted and managed appropriately. All the relevant statistical data will be collected pre, intra, and post-operatively along with follow up data which will be recorded for each of the outcome measures (
                    <xref ref-type="fig" rid="f3">Figure 3</xref>). The obtained data will then be tabulated in an Excel sheet and a master chart will be created, and later be used for statistical analysis. To carry out the statistical analysis, SPSS version 27 software will be used. The analysis will be done considering the desired error of margin and confidence interval of 95%.</p>
                <fig fig-type="figure" id="f3" orientation="portrait" position="float">
                    <label>Figure 3. </label>
                    <caption>
                        <title>Study design.</title>
                    </caption>
                    <graphic id="gr3" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/147519/23df20e1-62e0-4bc8-965b-b4a717c2dd17_figure3.gif"/>
                </fig>
                <p>This protocol is addressed in accordance with SPIRIT reporting guidelines.
                    <sup>
                        <xref ref-type="bibr" rid="ref28">28</xref>
                    </sup>
                </p>
            </sec>
            <sec id="sec12">
                <title>Dissemination</title>
                <p>This study will be published in indexed journal.</p>
            </sec>
            <sec id="sec13">
                <title>Study status</title>
                <p>Data collection has not yet started.</p>
            </sec>
        </sec>
        <sec id="sec14" sec-type="discussion">
            <title>Discussion</title>
            <p>The main aim of this study is to produce an outcome analysis of the participants&#x2019; PCL injuries. This is a clinical trial protocol carried out in the Department of Orthopaedics in Jawaharlal Nehru Medical College, Wardha, Maharashtra, India. As the prevalence and occurrence of PCL injuries are now increasing, and there are various treatment options available, it is necessary to investigate the outcome analysis of PCL injuries.
                <sup>
                    <xref ref-type="bibr" rid="ref23">23</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref29">29</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref30">30</xref>
                </sup>
            </p>
            <p>The Lysholm knee scoring scale and the IKDC knee scoring system have different domains for the assessment of quality and function of the knee joint. The scales include items on the patient&#x2019;s satisfaction and expectation with functional parameters related to the knee joint health. Assessment using these scales will tell us about success of the performed PCL surgeries.
                <sup>
                    <xref ref-type="bibr" rid="ref31">31</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref32">32</xref>
                </sup>
            </p>
            <p>Using the data obtained from the measurement of pre and post-study scoring scales, we will perform statistical analysis and compare the analyses for different PCL outcomes.
                <sup>
                    <xref ref-type="bibr" rid="ref33">33</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref34">34</xref>
                </sup>
            </p>
            <p>Limitations of this study include small sample size, single centre study, and short duration of study.</p>
            <sec id="sec15">
                <title>Ethical considerations</title>
                <p>This research protocol received approval from the institutional ethical committee of the Datta Meghe Institute of Higher Education and Research (approval number ECR/440/Inst/MH/2013/RR-2019) on 18/07/2022.</p>
                <p>All participants will be educated about the purpose of the research. Written and verbal informed consent will be obtained from all the participants by the principal investigator prior to the intervention. Procedures in this study will be conducted in accordance with the Helsinki Declaration of 1975, as referenced in 2008.</p>
                <p>The study material will be considered to be confidential documents and will be safely stored with access only to the principal investigator.</p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec19" sec-type="data-availability">
            <title>Data availability</title>
            <sec id="sec20">
                <title>Underlying data</title>
                <p>No underlying data are associated with this protocol.</p>
            </sec>
            <sec id="sec21">
                <title>Extended data</title>
                <p>Zenodo: Outcome analysis of Posterior Cruciate Ligament injuries. 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.5281/zenodo.8050632">https://doi.org/10.5281/zenodo.8050632</ext-link>
                </p>
                <p>This project contains the following extended data:
                    <list list-type="bullet">
                        <list-item>
                            <label>-</label>
                            <p>Study flow design.docx</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Informed consent (English and Marathi).docx</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>IKDC knee scoring system.docx</p>
                        </list-item>
                        <list-item>
                            <label>-</label>
                            <p>Lysholm Knee scoring scale.docx
</p>
                        </list-item>
                    </list>
                </p>
                <p>Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution 4.0 International license</ext-link> (CC-BY 4.0).</p>
            </sec>
            <sec id="sec16">
                <title>Reporting guidelines</title>
                <p>Zenodo: SPIRIT checklist for &#x2018;Outcome analysis of posterior cruciate ligament injuries&#x2019;, 
                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.5281/zenodo.8050632">https://doi.org/10.5281/zenodo.8050632</ext-link>.</p>
            </sec>
        </sec>
        <ack>
            <title>Acknowledgements</title>
            <p>I express my gratitude to Dr. Swapnil Date for his indespensible role in my better understanding of the subject. His knowledge, expertise and constant moral support throughout helped me tremendously. I am grateful for his help in the final corrections and editing of my protocol.</p>
            <p>The author also expresses gratitude to all personnel at the department of orthopaedics in JNMC, AVBRH, Sawangi, Wardha, Maharashtra, India for their assistance.</p>
        </ack>
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    <sub-article article-type="reviewer-report" id="report210698">
        <front-stub>
            <article-id pub-id-type="doi">10.5256/f1000research.147519.r210698</article-id>
            <title-group>
                <article-title>Reviewer response for version 1</article-title>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author">
                    <name>
                        <surname>Tan</surname>
                        <given-names>Si Heng Sharon</given-names>
                    </name>
                    <xref ref-type="aff" rid="r210698a1">1</xref>
                    <role>Referee</role>
                </contrib>
                <aff id="r210698a1">
                    <label>1</label>Department of Orthopaedic Surgery, National University Hospital Sports Centre, National University Health System, Singapore, Singapore</aff>
            </contrib-group>
            <author-notes>
                <fn fn-type="conflict">
                    <p>
                        <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>10</day>
                <month>11</month>
                <year>2023</year>
            </pub-date>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Tan SHS</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access peer review report distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <related-article ext-link-type="doi" id="relatedArticleReport210698" related-article-type="peer-reviewed-article" xlink:href="10.12688/f1000research.134461.1"/>
            <custom-meta-group>
                <custom-meta>
                    <meta-name>recommendation</meta-name>
                    <meta-value>approve-with-reservations</meta-value>
                </custom-meta>
            </custom-meta-group>
        </front-stub>
        <body>
            <p>This is a well-written protocol for the analysis of outcomes following surgical management for posterior cruciate ligament injuries. It is a protocol for a single-arm study, and the sample size calculated is also for a single-arm study, therefore while it is sufficient for a case series, it would not be sufficient for a comparative study. Specific to the sample size calculation, may I ask why a 0.07 error of margin was chosen?</p>
            <p>Is the study design appropriate for the research question?</p>
            <p>Yes</p>
            <p>Is the rationale for, and objectives of, the study clearly described?</p>
            <p>Yes</p>
            <p>Are sufficient details of the methods provided to allow replication by others?</p>
            <p>Yes</p>
            <p>Are the datasets clearly presented in a useable and accessible format?</p>
            <p>Not applicable</p>
            <p>Reviewer Expertise:</p>
            <p>NA</p>
            <p>I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.</p>
        </body>
        <sub-article article-type="response" id="comment10974-210698">
            <front-stub>
                <contrib-group>
                    <contrib contrib-type="author">
                        <name>
                            <surname>Suneja</surname>
                            <given-names>Anmol</given-names>
                        </name>
                        <aff>Orthopaedics, Dutta Meghe Institute of Higher Education and Research Centre, Wardha, Maharashtra, India</aff>
                    </contrib>
                </contrib-group>
                <author-notes>
                    <fn fn-type="conflict">
                        <p>
                            <bold>Competing interests: </bold>No competing interests were disclosed.</p>
                    </fn>
                </author-notes>
                <pub-date pub-type="epub">
                    <day>30</day>
                    <month>1</month>
                    <year>2024</year>
                </pub-date>
            </front-stub>
            <body>
                <p>This is a single arm study to find the difference in outcomes for pre &amp; post evaluation after operative procedure. The cases that we are taking are having lesser prevalance, so this study can be done in case series format also. We are taking estimation error at 7% for lesser prevalence of study cases.</p>
            </body>
        </sub-article>
    </sub-article>
</article>
