<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/NCT04431063</url>
  </required_header>
  <id_info>
    <org_study_id>18-10-1173</org_study_id>
    <nct_id>NCT04431063</nct_id>
  </id_info>
  <brief_title>Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case in Cipto Mangunkusumo Hospital in Jakarta With 24 Patient as Subject Who Will Divide Into 2 Group.</brief_title>
  <official_title>Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case .</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Injury of the Anterior Cruciate Ligament (ACL) is one of the most common sports injuries. The&#xD;
      incidence rate reaches 68.6 cases per 100,000 people per year. Management of ACL injuries for&#xD;
      individuals who want to return to the level of exercise activity as before, mostly in the&#xD;
      form of reconstructive surgery. As many as 60,000 to 175,000 cases of ACL reconstruction per&#xD;
      year are carried out in the United States At present, many reconstructive surgeries are&#xD;
      performed by taking tendon grafts on the patient's own body (autograft) to then be used&#xD;
      instead of the ACL. The most widely used graft sources are Hamstring and Bone-Patellar&#xD;
      Tendon-Bone (BPTB) grafts. Other alternative grafts are Quadriceps tendon, Fascia Lata,&#xD;
      Iliotibial Band, and Peroneus Longus Tendon. Each graft retrieval technique has advantages&#xD;
      and disadvantages. BPTB graft has the best tensile strength and bone union with bone, but the&#xD;
      complications of anterior knee pain are also quite common (5-55%). Hamstring grafts and&#xD;
      Quadriceps grafts minimize the complications of anterior knee pain, with fairly good tensile&#xD;
      strength, but the union of grafts with bone takes longer. The loss of Hamstring tendons also&#xD;
      causes a decrease in muscle strength in Hamstring, where Hamstring has an important role in&#xD;
      preventing the anterior translation of the tibia Peroneus Longus Tendon graft is an&#xD;
      alternative graft developed to minimize complications associated with graft use from the area&#xD;
      around the knee. Peroneus Longus tendons also have tensile strength similar to Hamstring&#xD;
      tendons.&#xD;
&#xD;
      As with other graft extracts, Peroneus Longus tendon graft is also accompanied by&#xD;
      complications in the donor site. Possible complications arising from the loss of the Peroneus&#xD;
      Longus tendon include ankle instability and decreased flexion strength of the 1st ray and&#xD;
      ankle eversion. Research carried out by Bancha et al showed a reduction in flexion strength&#xD;
      of 1st ray and ankle eversion significantly, without any instability in the ankle. Peroneus&#xD;
      longus provides 5.5% strength for moderate dorsiflexion for ankle eversion movements,&#xD;
      peroneus longus is the main muscle. But in other studies it is said that the use of peroneus&#xD;
      longus graft does not interfere with the stability of the ankle and ROM. Does not even affect&#xD;
      the functional outcome of the ankle However, in a study conducted by Bancha et al and&#xD;
      Kerimoglu et al., The technique used for taking Peroneus Longus graft tendons did not include&#xD;
      suturing in the distal stump of Peroneous Longus. So with this study, researchers wanted to&#xD;
      find out whether different results would be found related to donor site complications if the&#xD;
      technique used included suturing the distal stump of the Peroneus Longus tendon against the&#xD;
      peroneus brevis tendon&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preoperative hand dynamometer value</measure>
    <time_frame>This measurement was carried out at the preoperative setting</time_frame>
    <description>Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Three-months postoperative hand dynamometer value</measure>
    <time_frame>This measurement was carried out at 3 months postoperatively</time_frame>
    <description>Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-months postoperative hand dynamometer value</measure>
    <time_frame>This measurement was carried out at 6 months postoperatively</time_frame>
    <description>Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preoperative Clark's Angle Value</measure>
    <time_frame>This measurement was carried out at the preoperative setting</time_frame>
    <description>the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of &lt; 31° means there is tendency to flatness and/or pronation. angle of 31° to &lt; 45° is the normal range. Clarke Angle of &gt; 45° means there is tendency to cavus foot</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Three-months Clark's Angle Value</measure>
    <time_frame>This measurement was carried out at the 3 months postoperatively</time_frame>
    <description>the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of &lt; 31° means there is tendency to flatness and/or pronation. angle of 31° to &lt; 45° is the normal range. Clarke Angle of &gt; 45° means there is tendency to cavus foot</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-months Clark's Angle Value</measure>
    <time_frame>This measurement was carried out at the 6 months postoperatively</time_frame>
    <description>the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of &lt; 31° means there is tendency to flatness and/or pronation. angle of 31° to &lt; 45° is the normal range. Clarke Angle of &gt; 45° means there is tendency to cavus foot</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preoperative the American Orthopedic Foot and Ankle Score (AOFAS)</measure>
    <time_frame>Examination carried out 4 times for each patient in preoperative setting</time_frame>
    <description>the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Three months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)</measure>
    <time_frame>Examination carried out 4 times for each patient in 3 months postoperatively</time_frame>
    <description>the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)</measure>
    <time_frame>Examination carried out 4 times for each patient in 6 months postoperatively</time_frame>
    <description>the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preoperative visual analogue scale foot and ankle (VAS-FA)</measure>
    <time_frame>Examination carried out 4 times for each patient at preoperative setting</time_frame>
    <description>the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. VAS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Three-months postoperative visual analogue scale foot and ankle (VAS-FA)</measure>
    <time_frame>Examination carried out 4 times for each patient at 3 months postoperatively</time_frame>
    <description>the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Six-months postoperative visual analogue scale foot and ankle (VAS-FA)</measure>
    <time_frame>Examination carried out 4 times for each patient at 6 months postoperatively</time_frame>
    <description>the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Rupture of Anterior Cruciate Ligament</condition>
  <arm_group>
    <arm_group_label>Sutured Stump</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group consist of subject with distal stump suturing of perobeus longus agains peroneus brevis in ACL Reconstruction Case</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Unsutured Stump</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The group consist of subject without distal stump suturing of peroneus longus agains peroneus brevis in ACL Reconstruction Case</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Distal Stump Suturing</intervention_name>
    <description>in ACL Reconstruction case , Group A consist of subject with operation procedure suturing the distal stump peroneus longus against the peroneus brevis in ACL reconstruction using the peroneus longus autograft.</description>
    <arm_group_label>Sutured Stump</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with total ACL rupture using peroneus longus graft&#xD;
&#xD;
          -  The suturing procedure for the distal stump peroneus longus against the peroneus&#xD;
             brevis tendon is performed by orthopedic specialists or resident chiefs who have been&#xD;
             given training in advance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Osteoarthtis Knee Kellgren-Lawrence III and IV&#xD;
&#xD;
          -  Osteoarthtis Knee Kellgren-Lawrence III and IV&#xD;
&#xD;
          -  Flatfoot as evidenced by physical examination and footprinting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cipto Mangunkusumo Hospital</name>
      <address>
        <city>Jakarta</city>
        <state>DKI Jakarta</state>
        <zip>14250</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <reference>
    <citation>Lyman S, Koulouvaris P, Sherman S, Do H, Mandl LA, Marx RG. Epidemiology of anterior cruciate ligament reconstruction: trends, readmissions, and subsequent knee surgery. J Bone Joint Surg Am. 2009 Oct;91(10):2321-8. doi: 10.2106/JBJS.H.00539.</citation>
    <PMID>19797565</PMID>
  </reference>
  <reference>
    <citation>Angthong C, Chernchujit B, Apivatgaroon A, Chaijenkit K, Nualon P, Suchao-in K. The Anterior Cruciate Ligament Reconstruction with the Peroneus Longus Tendon: A Biomechanical and Clinical Evaluation of the Donor Ankle Morbidity. J Med Assoc Thai. 2015 Jun;98(6):555-60.</citation>
    <PMID>26219159</PMID>
  </reference>
  <reference>
    <citation>Cerulli G, Placella G, Sebastiani E, Tei MM, Speziali A, Manfreda F. ACL Reconstruction: Choosing the Graft. Joints. 2013 Jun 12;1(1):18-24. eCollection 2013 Mar.</citation>
    <PMID>25606507</PMID>
  </reference>
  <reference>
    <citation>Kerimoglu S, Aynaci O, Saracoglu M, Aydin H, Turhan AU. [Anterior cruciate ligament reconstruction with the peroneus longus tendon]. Acta Orthop Traumatol Turc. 2008 Jan-Feb;42(1):38-43. doi: 10.3944/aott.2008.038. Turkish.</citation>
    <PMID>18354276</PMID>
  </reference>
  <reference>
    <citation>Silver RL, de la Garza J, Rang M. The myth of muscle balance. A study of relative strengths and excursions of normal muscles about the foot and ankle. J Bone Joint Surg Br. 1985 May;67(3):432-7. doi: 10.1302/0301-620X.67B3.3997956.</citation>
    <PMID>3997956</PMID>
  </reference>
  <reference>
    <citation>Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797. Erratum In: N Engl J Med. 2010 Aug 26;363(9):893.</citation>
    <PMID>20660401</PMID>
  </reference>
  <reference>
    <citation>Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.</citation>
    <PMID>26509265</PMID>
  </reference>
  <reference>
    <citation>Click Fenter P, Bellew JW, Pitts T, Kay R. A comparison of 3 hand-held dynamometers used to measure hip abduction strength. J Strength Cond Res. 2003 Aug;17(3):531-5. doi: 10.1519/1533-4287(2003)0172.0.co;2.</citation>
    <PMID>12930182</PMID>
  </reference>
  <reference>
    <citation>Surburg PR, Suomi R, Poppy WK. Validity and reliability of a hand-held dynamometer with two populations. J Orthop Sports Phys Ther. 1992;16(5):229-34. doi: 10.2519/jospt.1992.16.5.229.</citation>
    <PMID>18796754</PMID>
  </reference>
  <reference>
    <citation>Murley GS, Tan JM, Edwards RM, De Luca J, Munteanu SE, Cook JL. Foot posture is associated with morphometry of the peroneus longus muscle, tibialis anterior tendon, and Achilles tendon. Scand J Med Sci Sports. 2014 Jun;24(3):535-41. doi: 10.1111/sms.12025. Epub 2013 Jan 10.</citation>
    <PMID>23301865</PMID>
  </reference>
  <reference>
    <citation>Pita-Fernandez S, Gonzalez-Martin C, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Validity of footprint analysis to determine flatfoot using clinical diagnosis as the gold standard in a random sample aged 40 years and older. J Epidemiol. 2015;25(2):148-54. doi: 10.2188/jea.JE20140082. Epub 2014 Nov 8.</citation>
    <PMID>25382154</PMID>
  </reference>
  <reference>
    <citation>Gonzalez-Martin C, Pita-Fernandez S, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Variability between Clarke's angle and Chippaux-Smirak index for the diagnosis of flat feet. Colomb Med (Cali). 2017 Mar 30;48(1):25-31.</citation>
    <PMID>28559643</PMID>
  </reference>
  <reference>
    <citation>Quatman CE, Hewett TE. The anterior cruciate ligament injury controversy: is &quot;valgus collapse&quot; a sex-specific mechanism? Br J Sports Med. 2009 May;43(5):328-35. doi: 10.1136/bjsm.2009.059139. Epub 2009 Apr 15. Erratum In: Br J Sports Med. 2021 Aug;55(16):e6.</citation>
    <PMID>19372087</PMID>
  </reference>
  <reference>
    <citation>McGuine TA, Winterstein AP, Carr K, Hetzel S. Changes in Health-Related Quality of Life and Knee Function After Knee Injury in Young Female Athletes. Orthop J Sports Med. 2014 Apr 22;2(4):2325967114530988. doi: 10.1177/2325967114530988. eCollection 2014 Apr.</citation>
    <PMID>26535324</PMID>
  </reference>
  <reference>
    <citation>Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part I. Am J Sports Med. 2005 Oct;33(10):1579-602. doi: 10.1177/0363546505279913.</citation>
    <PMID>16199611</PMID>
  </reference>
  <reference>
    <citation>Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med. 2005 Nov;33(11):1751-67. doi: 10.1177/0363546505279922.</citation>
    <PMID>16230470</PMID>
  </reference>
  <reference>
    <citation>Mihelic R, Jurdana H, Jotanovic Z, Madjarevic T, Tudor A. Long-term results of anterior cruciate ligament reconstruction: a comparison with non-operative treatment with a follow-up of 17-20 years. Int Orthop. 2011 Jul;35(7):1093-7. doi: 10.1007/s00264-011-1206-x. Epub 2011 Feb 2.</citation>
    <PMID>21287172</PMID>
  </reference>
  <reference>
    <citation>Schindler OS. Surgery for anterior cruciate ligament deficiency: a historical perspective. Knee Surg Sports Traumatol Arthrosc. 2012 Jan;20(1):5-47. doi: 10.1007/s00167-011-1756-x. Epub 2011 Nov 22.</citation>
    <PMID>22105976</PMID>
  </reference>
  <reference>
    <citation>Felmet G. Implant-free press-fit fixation for bone-patellar tendon-bone ACL reconstruction: 10-year results. Arch Orthop Trauma Surg. 2010 Aug;130(8):985-92. doi: 10.1007/s00402-010-1050-2. Epub 2010 Jan 22.</citation>
    <PMID>20094723</PMID>
  </reference>
  <reference>
    <citation>Willis-Owen CA, Hearn TC, Keene GC, Costi JJ. Biomechanical testing of implant free wedge shaped bone block fixation for bone patellar tendon bone anterior cruciate ligament reconstruction in a bovine model. J Orthop Surg Res. 2010 Sep 2;5:66. doi: 10.1186/1749-799X-5-66.</citation>
    <PMID>20813059</PMID>
  </reference>
  <reference>
    <citation>Pavlik A, Hidas P, Tallay A, Toman J, Berkes I. Femoral press-fit fixation technique in anterior cruciate ligament reconstruction using bone-patellar tendon-bone graft: a prospective clinical evaluation of 285 patients. Am J Sports Med. 2006 Feb;34(2):220-5. doi: 10.1177/0363546505279920. Epub 2005 Oct 6.</citation>
    <PMID>16210575</PMID>
  </reference>
  <reference>
    <citation>Dargel J, Schmidt-Wiethoff R, Schneider T, Bruggemann GP, Koebke J. Biomechanical testing of quadriceps tendon-patellar bone grafts: an alternative graft source for press-fit anterior cruciate ligament reconstruction? Arch Orthop Trauma Surg. 2006 May;126(4):265-70. doi: 10.1007/s00402-005-0048-7. Epub 2005 Sep 17.</citation>
    <PMID>16172862</PMID>
  </reference>
  <reference>
    <citation>van Eck CF, Kropf EJ, Romanowski JR, Lesniak BP, Tranovich MJ, van Dijk CN, Fu FH. Factors that influence the intra-articular rupture pattern of the ACL graft following single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1243-8. doi: 10.1007/s00167-011-1427-y. Epub 2011 Feb 11.</citation>
    <PMID>21311861</PMID>
  </reference>
  <reference>
    <citation>Zaffagnini S, Marcacci M, Lo Presti M, Giordano G, Iacono F, Neri MP. Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1060-9. doi: 10.1007/s00167-006-0130-x. Epub 2006 Aug 15.</citation>
    <PMID>16909301</PMID>
  </reference>
  <reference>
    <citation>Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD005960. doi: 10.1002/14651858.CD005960.pub2.</citation>
    <PMID>21901700</PMID>
  </reference>
  <reference>
    <citation>Freedman KB, D'Amato MJ, Nedeff DD, Kaz A, Bach BR Jr. Arthroscopic anterior cruciate ligament reconstruction: a metaanalysis comparing patellar tendon and hamstring tendon autografts. Am J Sports Med. 2003 Jan-Feb;31(1):2-11. doi: 10.1177/03635465030310011501.</citation>
    <PMID>12531750</PMID>
  </reference>
  <reference>
    <citation>Lee YH, Kuroda R, Zhao J, Chan KM. A tale of 10 European centres - 2010 APOSSM travelling fellowship review in ACL surgery. Sports Med Arthrosc Rehabil Ther Technol. 2012 Jul 28;4(1):27. doi: 10.1186/1758-2555-4-27.</citation>
    <PMID>22839644</PMID>
  </reference>
  <reference>
    <citation>van Dijk PA, Lubberts B, Verheul C, DiGiovanni CW, Kerkhoffs GM. Rehabilitation after surgical treatment of peroneal tendon tears and ruptures. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1165-74. doi: 10.1007/s00167-015-3944-6. Epub 2016 Jan 23.</citation>
    <PMID>26803783</PMID>
  </reference>
  <reference>
    <citation>Lin TW, Cardenas L, Soslowsky LJ. Biomechanics of tendon injury and repair. J Biomech. 2004 Jun;37(6):865-77. doi: 10.1016/j.jbiomech.2003.11.005.</citation>
    <PMID>15111074</PMID>
  </reference>
  <reference>
    <citation>Yang G, Rothrauff BB, Tuan RS. Tendon and ligament regeneration and repair: clinical relevance and developmental paradigm. Birth Defects Res C Embryo Today. 2013 Sep;99(3):203-222. doi: 10.1002/bdrc.21041.</citation>
    <PMID>24078497</PMID>
  </reference>
  <results_reference>
    <citation>Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.</citation>
    <PMID>26920430</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>May 20, 2023</last_update_submitted>
  <last_update_submitted_qc>May 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Andri Maruli Tua Lubis</investigator_full_name>
    <investigator_title>Orthopaedic Surgeon</investigator_title>
  </responsible_party>
  <keyword>ACL</keyword>
  <keyword>Rupture of ACL</keyword>
  <keyword>Donor site</keyword>
  <keyword>Peroneus Longus Graft</keyword>
  <keyword>Distal Stump</keyword>
  <keyword>Peroneus Brevis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</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/NCT04431063
org study id: 18-10-1173
nct id: NCT04431063
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Injury of the Anterior Cruciate Ligament (ACL) is one of the most common sports injuries. The
      incidence rate reaches 68.6 cases per 100,000 people per year. Management of ACL injuries for
      individuals who want to return to the level of exercise activity as before, mostly in the
      form of reconstructive surgery. As many as 60,000 to 175,000 cases of ACL reconstruction per
      year are carried out in the United States At present, many reconstructive surgeries are
      performed by taking tendon grafts on the patient's own body (autograft) to then be used
      instead of the ACL. The most widely used graft sources are Hamstring and Bone-Patellar
      Tendon-Bone (BPTB) grafts. Other alternative grafts are Quadriceps tendon, Fascia Lata,
      Iliotibial Band, and Peroneus Longus Tendon. Each graft retrieval technique has advantages
      and disadvantages. BPTB graft has the best tensile strength and bone union with bone, but the
      complications of anterior knee pain are also quite common (5-55%). Hamstring grafts and
      Quadriceps grafts minimize the complications of anterior knee pain, with fairly good tensile
      strength, but the union of grafts with bone takes longer. The loss of Hamstring tendons also
      causes a decrease in muscle strength in Hamstring, where Hamstring has an important role in
      preventing the anterior translation of the tibia Peroneus Longus Tendon graft is an
      alternative graft developed to minimize complications associated with graft use from the area
      around the knee. Peroneus Longus tendons also have tensile strength similar to Hamstring
      tendons.

      As with other graft extracts, Peroneus Longus tendon graft is also accompanied by
      complications in the donor site. Possible complications arising from the loss of the Peroneus
      Longus tendon include ankle instability and decreased flexion strength of the 1st ray and
      ankle eversion. Research carried out by Bancha et al showed a reduction in flexion strength
      of 1st ray and ankle eversion significantly, without any instability in the ankle. Peroneus
      longus provides 5.5% strength for moderate dorsiflexion for ankle eversion movements,
      peroneus longus is the main muscle. But in other studies it is said that the use of peroneus
      longus graft does not interfere with the stability of the ankle and ROM. Does not even affect
      the functional outcome of the ankle However, in a study conducted by Bancha et al and
      Kerimoglu et al., The technique used for taking Peroneus Longus graft tendons did not include
      suturing in the distal stump of Peroneous Longus. So with this study, researchers wanted to
      find out whether different results would be found related to donor site complications if the
      technique used included suturing the distal stump of the Peroneus Longus tendon against the
      peroneus brevis tendon
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Preoperative hand dynamometer value
time frame: This measurement was carried out at the preoperative setting
description: Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
measure: Three-months postoperative hand dynamometer value
time frame: This measurement was carried out at 3 months postoperatively
description: Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
measure: Six-months postoperative hand dynamometer value
time frame: This measurement was carried out at 6 months postoperatively
description: Value of objective measurement of the strength of the medial part of the plantarflexion in the one metatarsal head with the hand of the Dynamometer when the patient is supine. The measurement is done 3 times and the value used is the average of the 3 times the measurement. Healthy ankles were also examined as a comparison with the same measurement method. There is no minimum and maximum value, and the higher value the better the outcome
measure: Preoperative Clark's Angle Value
time frame: This measurement was carried out at the preoperative setting
description: the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
measure: Three-months Clark's Angle Value
time frame: This measurement was carried out at the 3 months postoperatively
description: the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
measure: Six-months Clark's Angle Value
time frame: This measurement was carried out at the 6 months postoperatively
description: the value of the objective angle measurement on the footprint by drawing a line from the medial side of the one metatarsal head and the heel against the second line which is connecting the one metatrsal head and the peak of the medial longitudinal arch. Clarke Angle of < 31° means there is tendency to flatness and/or pronation. angle of 31° to < 45° is the normal range. Clarke Angle of > 45° means there is tendency to cavus foot
measure: Preoperative the American Orthopedic Foot and Ankle Score (AOFAS)
time frame: Examination carried out 4 times for each patient in preoperative setting
description: the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
measure: Three months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
time frame: Examination carried out 4 times for each patient in 3 months postoperatively
description: the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
measure: Six months postoperative the American Orthopedic Foot and Ankle Score (AOFAS)
time frame: Examination carried out 4 times for each patient in 6 months postoperatively
description: the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AOFAS score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
measure: Preoperative visual analogue scale foot and ankle (VAS-FA)
time frame: Examination carried out 4 times for each patient at preoperative setting
description: the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. VAS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
measure: Three-months postoperative visual analogue scale foot and ankle (VAS-FA)
time frame: Examination carried out 4 times for each patient at 3 months postoperatively
description: the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
measure: Six-months postoperative visual analogue scale foot and ankle (VAS-FA)
time frame: Examination carried out 4 times for each patient at 6 months postoperatively
description: the questionnaire for assessing the function of both injured feet and ankles and the knee that is in the process of healing. AS-FA score has the range of value of 0 to 100. 0 is the worst value and 100 is the best value possible
arm group label: Sutured Stump
arm group type: Experimental
description: The group consist of subject with distal stump suturing of perobeus longus agains peroneus brevis in ACL Reconstruction Case
arm group label: Unsutured Stump
arm group type: No Intervention
description: The group consist of subject without distal stump suturing of peroneus longus agains peroneus brevis in ACL Reconstruction Case
intervention type: Procedure
intervention name: Distal Stump Suturing
description: in ACL Reconstruction case , Group A consist of subject with operation procedure suturing the distal stump peroneus longus against the peroneus brevis in ACL reconstruction using the peroneus longus autograft.
arm group label: Sutured Stump
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Indonesia
citation: Lyman S, Koulouvaris P, Sherman S, Do H, Mandl LA, Marx RG. Epidemiology of anterior cruciate ligament reconstruction: trends, readmissions, and subsequent knee surgery. J Bone Joint Surg Am. 2009 Oct;91(10):2321-8. doi: 10.2106/JBJS.H.00539.
PMID: 19797565
citation: Angthong C, Chernchujit B, Apivatgaroon A, Chaijenkit K, Nualon P, Suchao-in K. The Anterior Cruciate Ligament Reconstruction with the Peroneus Longus Tendon: A Biomechanical and Clinical Evaluation of the Donor Ankle Morbidity. J Med Assoc Thai. 2015 Jun;98(6):555-60.
PMID: 26219159
citation: Cerulli G, Placella G, Sebastiani E, Tei MM, Speziali A, Manfreda F. ACL Reconstruction: Choosing the Graft. Joints. 2013 Jun 12;1(1):18-24. eCollection 2013 Mar.
PMID: 25606507
citation: Kerimoglu S, Aynaci O, Saracoglu M, Aydin H, Turhan AU. [Anterior cruciate ligament reconstruction with the peroneus longus tendon]. Acta Orthop Traumatol Turc. 2008 Jan-Feb;42(1):38-43. doi: 10.3944/aott.2008.038. Turkish.
PMID: 18354276
citation: Silver RL, de la Garza J, Rang M. The myth of muscle balance. A study of relative strengths and excursions of normal muscles about the foot and ankle. J Bone Joint Surg Br. 1985 May;67(3):432-7. doi: 10.1302/0301-620X.67B3.3997956.
PMID: 3997956
citation: Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS. A randomized trial of treatment for acute anterior cruciate ligament tears. N Engl J Med. 2010 Jul 22;363(4):331-42. doi: 10.1056/NEJMoa0907797. Erratum In: N Engl J Med. 2010 Aug 26;363(9):893.
PMID: 20660401
citation: Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.
PMID: 26509265
citation: Click Fenter P, Bellew JW, Pitts T, Kay R. A comparison of 3 hand-held dynamometers used to measure hip abduction strength. J Strength Cond Res. 2003 Aug;17(3):531-5. doi: 10.1519/1533-4287(2003)0172.0.co;2.
PMID: 12930182
citation: Surburg PR, Suomi R, Poppy WK. Validity and reliability of a hand-held dynamometer with two populations. J Orthop Sports Phys Ther. 1992;16(5):229-34. doi: 10.2519/jospt.1992.16.5.229.
PMID: 18796754
citation: Murley GS, Tan JM, Edwards RM, De Luca J, Munteanu SE, Cook JL. Foot posture is associated with morphometry of the peroneus longus muscle, tibialis anterior tendon, and Achilles tendon. Scand J Med Sci Sports. 2014 Jun;24(3):535-41. doi: 10.1111/sms.12025. Epub 2013 Jan 10.
PMID: 23301865
citation: Pita-Fernandez S, Gonzalez-Martin C, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Validity of footprint analysis to determine flatfoot using clinical diagnosis as the gold standard in a random sample aged 40 years and older. J Epidemiol. 2015;25(2):148-54. doi: 10.2188/jea.JE20140082. Epub 2014 Nov 8.
PMID: 25382154
citation: Gonzalez-Martin C, Pita-Fernandez S, Seoane-Pillado T, Lopez-Calvino B, Pertega-Diaz S, Gil-Guillen V. Variability between Clarke's angle and Chippaux-Smirak index for the diagnosis of flat feet. Colomb Med (Cali). 2017 Mar 30;48(1):25-31.
PMID: 28559643
citation: Quatman CE, Hewett TE. The anterior cruciate ligament injury controversy: is "valgus collapse" a sex-specific mechanism? Br J Sports Med. 2009 May;43(5):328-35. doi: 10.1136/bjsm.2009.059139. Epub 2009 Apr 15. Erratum In: Br J Sports Med. 2021 Aug;55(16):e6.
PMID: 19372087
citation: McGuine TA, Winterstein AP, Carr K, Hetzel S. Changes in Health-Related Quality of Life and Knee Function After Knee Injury in Young Female Athletes. Orthop J Sports Med. 2014 Apr 22;2(4):2325967114530988. doi: 10.1177/2325967114530988. eCollection 2014 Apr.
PMID: 26535324
citation: Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part I. Am J Sports Med. 2005 Oct;33(10):1579-602. doi: 10.1177/0363546505279913.
PMID: 16199611
citation: Beynnon BD, Johnson RJ, Abate JA, Fleming BC, Nichols CE. Treatment of anterior cruciate ligament injuries, part 2. Am J Sports Med. 2005 Nov;33(11):1751-67. doi: 10.1177/0363546505279922.
PMID: 16230470
citation: Mihelic R, Jurdana H, Jotanovic Z, Madjarevic T, Tudor A. Long-term results of anterior cruciate ligament reconstruction: a comparison with non-operative treatment with a follow-up of 17-20 years. Int Orthop. 2011 Jul;35(7):1093-7. doi: 10.1007/s00264-011-1206-x. Epub 2011 Feb 2.
PMID: 21287172
citation: Schindler OS. Surgery for anterior cruciate ligament deficiency: a historical perspective. Knee Surg Sports Traumatol Arthrosc. 2012 Jan;20(1):5-47. doi: 10.1007/s00167-011-1756-x. Epub 2011 Nov 22.
PMID: 22105976
citation: Felmet G. Implant-free press-fit fixation for bone-patellar tendon-bone ACL reconstruction: 10-year results. Arch Orthop Trauma Surg. 2010 Aug;130(8):985-92. doi: 10.1007/s00402-010-1050-2. Epub 2010 Jan 22.
PMID: 20094723
citation: Willis-Owen CA, Hearn TC, Keene GC, Costi JJ. Biomechanical testing of implant free wedge shaped bone block fixation for bone patellar tendon bone anterior cruciate ligament reconstruction in a bovine model. J Orthop Surg Res. 2010 Sep 2;5:66. doi: 10.1186/1749-799X-5-66.
PMID: 20813059
citation: Pavlik A, Hidas P, Tallay A, Toman J, Berkes I. Femoral press-fit fixation technique in anterior cruciate ligament reconstruction using bone-patellar tendon-bone graft: a prospective clinical evaluation of 285 patients. Am J Sports Med. 2006 Feb;34(2):220-5. doi: 10.1177/0363546505279920. Epub 2005 Oct 6.
PMID: 16210575
citation: Dargel J, Schmidt-Wiethoff R, Schneider T, Bruggemann GP, Koebke J. Biomechanical testing of quadriceps tendon-patellar bone grafts: an alternative graft source for press-fit anterior cruciate ligament reconstruction? Arch Orthop Trauma Surg. 2006 May;126(4):265-70. doi: 10.1007/s00402-005-0048-7. Epub 2005 Sep 17.
PMID: 16172862
citation: van Eck CF, Kropf EJ, Romanowski JR, Lesniak BP, Tranovich MJ, van Dijk CN, Fu FH. Factors that influence the intra-articular rupture pattern of the ACL graft following single-bundle reconstruction. Knee Surg Sports Traumatol Arthrosc. 2011 Aug;19(8):1243-8. doi: 10.1007/s00167-011-1427-y. Epub 2011 Feb 11.
PMID: 21311861
citation: Zaffagnini S, Marcacci M, Lo Presti M, Giordano G, Iacono F, Neri MP. Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1060-9. doi: 10.1007/s00167-006-0130-x. Epub 2006 Aug 15.
PMID: 16909301
citation: Mohtadi NG, Chan DS, Dainty KN, Whelan DB. Patellar tendon versus hamstring tendon autograft for anterior cruciate ligament rupture in adults. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD005960. doi: 10.1002/14651858.CD005960.pub2.
PMID: 21901700
citation: Freedman KB, D'Amato MJ, Nedeff DD, Kaz A, Bach BR Jr. Arthroscopic anterior cruciate ligament reconstruction: a metaanalysis comparing patellar tendon and hamstring tendon autografts. Am J Sports Med. 2003 Jan-Feb;31(1):2-11. doi: 10.1177/03635465030310011501.
PMID: 12531750
citation: Lee YH, Kuroda R, Zhao J, Chan KM. A tale of 10 European centres - 2010 APOSSM travelling fellowship review in ACL surgery. Sports Med Arthrosc Rehabil Ther Technol. 2012 Jul 28;4(1):27. doi: 10.1186/1758-2555-4-27.
PMID: 22839644
citation: van Dijk PA, Lubberts B, Verheul C, DiGiovanni CW, Kerkhoffs GM. Rehabilitation after surgical treatment of peroneal tendon tears and ruptures. Knee Surg Sports Traumatol Arthrosc. 2016 Apr;24(4):1165-74. doi: 10.1007/s00167-015-3944-6. Epub 2016 Jan 23.
PMID: 26803783
citation: Lin TW, Cardenas L, Soslowsky LJ. Biomechanics of tendon injury and repair. J Biomech. 2004 Jun;37(6):865-77. doi: 10.1016/j.jbiomech.2003.11.005.
PMID: 15111074
citation: Yang G, Rothrauff BB, Tuan RS. Tendon and ligament regeneration and repair: clinical relevance and developmental paradigm. Birth Defects Res C Embryo Today. 2013 Sep;99(3):203-222. doi: 10.1002/bdrc.21041.
PMID: 24078497
citation: Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
PMID: 26920430
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Andri Maruli Tua Lubis
investigator title: Orthopaedic Surgeon
mesh term: Rupture
sharing ipd: Undecided