<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/NCT04456530</url>
  </required_header>
  <id_info>
    <org_study_id>SRF-030</org_study_id>
    <nct_id>NCT04456530</nct_id>
  </id_info>
  <brief_title>Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study</brief_title>
  <official_title>Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Stone Research Foundation for Sports Medicine and Arthritis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Stone Research Foundation for Sports Medicine and Arthritis</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in&#xD;
      patient's ability to return to activities. Although the use of testosterone in aging and&#xD;
      chronic muscle loss has been investigated, this study could prove short-term use of&#xD;
      testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by&#xD;
      bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical&#xD;
      quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM)&#xD;
      testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and&#xD;
      manual measurements of quadriceps cross-section.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an in vivo study using serial IM testosterone undeconate injections in participants&#xD;
      undergoing knee surgery with limited weight bearing post-operatively which includes&#xD;
      partial/total knee replacement, ACL reconstruction/revision, meniscal allograft&#xD;
      transplantation and articular cartilage paste grafting. The design is a randomized,&#xD;
      controlled, double blind, longitudinal study of intra-muscular injections of testosterone&#xD;
      versus saline control. Pre-operative and post-operative assessments will include: serial MRIs&#xD;
      and manual measurements of quadriceps cross-section and knee pain and function survey, KOOS.&#xD;
      Blood analysis will be performed for therapeutic assessment and safety. The participant will&#xD;
      receive two testosterone undeconate injections, once during their pre-operative visit and&#xD;
      once during their 1 month visit. Timing of assessments will be pre-operative, 1-4 days&#xD;
      post-operative and 1, 3, and 6 months. Measurement of the control group versus experimental&#xD;
      group at all time points may identify differences in participant response to testosterone&#xD;
      injections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">May 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Both the participant and analyzing MRI Radiologist will be blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in MRI Cross Sectional Area of the Quadriceps</measure>
    <time_frame>Pre-operative and 1, 3, and 6 months post-operative</time_frame>
    <description>T1 Axial and Sagittal planes will be obtained using a ONI 1.0T extremity MRI. Axial Cross sectional Area (cm^2) will be measured of the Quadriceps muscle.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Manual Measurements of the Quadriceps</measure>
    <time_frame>Pre-operative and 1, 3, and 6 months post-operative</time_frame>
    <description>Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Pain and Function Survey, KOOS</measure>
    <time_frame>Pre-operative and 1, 3, and 6 months post-operative</time_frame>
    <description>Evaluate the knee pain and function of subjects as measures by the KOOS assessment.&#xD;
Sections:&#xD;
Pain&#xD;
Symptoms&#xD;
Activities of Daily Living&#xD;
Sports and Recreation&#xD;
Quality of Life&#xD;
Scoring:&#xD;
Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in serum cortisol (mcg/dL) levels</measure>
    <time_frame>Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative</time_frame>
    <description>Laboratory blood analysis of cortisol will be performed for therapeutic assessment and safety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum testosterone (ng/dL) levels</measure>
    <time_frame>Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative</time_frame>
    <description>Laboratory blood analysis of testosterone will be performed for therapeutic assessment and safety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum prostate specific antigen (ng/mL) levels</measure>
    <time_frame>Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative</time_frame>
    <description>Laboratory blood analysis of PSA will be performed for therapeutic assessment and safety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in serum hepatic function panel (mg/dL) levels</measure>
    <time_frame>Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative</time_frame>
    <description>Laboratory blood analysis of HFP will be performed for therapeutic assessment and safety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in complete blood count with differential levels</measure>
    <time_frame>Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative</time_frame>
    <description>Laboratory blood analysis CBC w/ diff will be performed for therapeutic assessment and safety.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Muscle Atrophy</condition>
  <condition>Surgery</condition>
  <condition>Knee Injuries and Disorders</condition>
  <condition>Complication of Surgical Procedure</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Testosterone Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receiving two IM Testosterone injections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receiving two IM Normal Saline Injections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aveed 750 MG in 3 ML IM Injection</intervention_name>
    <description>Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.</description>
    <arm_group_label>Testosterone Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline 3 ML IM Injection</intervention_name>
    <description>Participants in the Control Group will receive two IM normal saline injections 1 month apart.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males age 18-65.&#xD;
&#xD;
          -  Undergoing significant knee surgery such as partial/total knee replacement, ligament&#xD;
             reconstruction, meniscus surgeries or articular cartilage paste grafting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men with carcinoma of the breast or known or suspected carcinoma of the prostate.&#xD;
&#xD;
          -  Men with BMI &gt; 30 and Type I or II diabetes diagnosis&#xD;
&#xD;
          -  Men prone to deep vein thrombosis or sleep apnea.&#xD;
&#xD;
          -  Men with pre-existing hematocrit abnormalities.&#xD;
&#xD;
          -  Men with pre-existing cardiac, renal, hepatic disease.&#xD;
&#xD;
          -  Men who are taking insulin, medicines that decrease blood clotting or corticosteroids.&#xD;
&#xD;
          -  Men with known hypersensitivity to testosterone undecanoate or any of its formulation&#xD;
             ingredients (testosterone, refined castor oil, benzyl benzoate).&#xD;
&#xD;
          -  Subject's unable or unwilling to comply with the protocol.&#xD;
&#xD;
          -  Subject's unable to provide informed consent.&#xD;
&#xD;
          -  Subject's unable to understand verbal and/or written English.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mani Vessal, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Stone Research Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stone Research Foundation</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.endo.com/File%20Library/Products/Prescribing%20Information/AVEED_prescribing_information.html</url>
    <description>Aveed Prescribing Information</description>
  </link>
  <reference>
    <citation>Bassil N, Alkaade S, Morley JE. The benefits and risks of testosterone replacement therapy: a review. Ther Clin Risk Manag. 2009 Jun;5(3):427-48. doi: 10.2147/tcrm.s3025. Epub 2009 Jun 22.</citation>
    <PMID>19707253</PMID>
  </reference>
  <reference>
    <citation>Nicholas JJ, Taylor FH, Buckingham RB, Ottonello D. Measurement of circumference of the knee with ordinary tape measure. Ann Rheum Dis. 1976 Jun;35(3):282-4. doi: 10.1136/ard.35.3.282.</citation>
    <PMID>984911</PMID>
  </reference>
  <reference>
    <citation>Arangio GA, Chen C, Kalady M, Reed JF 3rd. Thigh muscle size and strength after anterior cruciate ligament reconstruction and rehabilitation. J Orthop Sports Phys Ther. 1997 Nov;26(5):238-43. doi: 10.2519/jospt.1997.26.5.238.</citation>
    <PMID>9353686</PMID>
  </reference>
  <reference>
    <citation>Marcon M, Ciritsis B, Laux C, Nanz D, Nguyen-Kim TD, Fischer MA, Andreisek G, Ulbrich EJ. Cross-sectional area measurements versus volumetric assessment of the quadriceps femoris muscle in patients with anterior cruciate ligament reconstructions. Eur Radiol. 2015 Feb;25(2):290-8. doi: 10.1007/s00330-014-3424-2. Epub 2014 Oct 31.</citation>
    <PMID>25358592</PMID>
  </reference>
  <reference>
    <citation>Ruhdorfer AS, Dannhauer T, Wirth W, Cotofana S, Roemer F, Nevitt M, Eckstein F; OAI investigators. Thigh muscle cross-sectional areas and strength in knees with early vs knees without radiographic knee osteoarthritis: a between-knee, within-person comparison. Osteoarthritis Cartilage. 2014 Oct;22(10):1634-8. doi: 10.1016/j.joca.2014.06.002.</citation>
    <PMID>25278072</PMID>
  </reference>
  <reference>
    <citation>Orgiu S, Lafortuna CL, Rastelli F, Cadioli M, Falini A, Rizzo G. Automatic muscle and fat segmentation in the thigh from T1-Weighted MRI. J Magn Reson Imaging. 2016 Mar;43(3):601-10. doi: 10.1002/jmri.25031. Epub 2015 Aug 13.</citation>
    <PMID>26268693</PMID>
  </reference>
  <reference>
    <citation>Hartgens F, Kuipers H. Effects of androgenic-anabolic steroids in athletes. Sports Med. 2004;34(8):513-54. doi: 10.2165/00007256-200434080-00003.</citation>
    <PMID>15248788</PMID>
  </reference>
  <reference>
    <citation>Irrgang JJ, Ho H, Harner CD, Fu FH. Use of the International Knee Documentation Committee guidelines to assess outcome following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 1998;6(2):107-14. doi: 10.1007/s001670050082.</citation>
    <PMID>9604196</PMID>
  </reference>
  <reference>
    <citation>Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.</citation>
    <PMID>1285753</PMID>
  </reference>
  <reference>
    <citation>Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x.</citation>
    <PMID>12366624</PMID>
  </reference>
  <reference>
    <citation>Griggs RC, Kingston W, Jozefowicz RF, Herr BE, Forbes G, Halliday D. Effect of testosterone on muscle mass and muscle protein synthesis. J Appl Physiol (1985). 1989 Jan;66(1):498-503. doi: 10.1152/jappl.1989.66.1.498.</citation>
    <PMID>2917954</PMID>
  </reference>
  <reference>
    <citation>Akima H, Furukawa T. Atrophy of thigh muscles after meniscal lesions and arthroscopic partial menisectomy. Knee Surg Sports Traumatol Arthrosc. 2005 Nov;13(8):632-7. doi: 10.1007/s00167-004-0602-9. Epub 2005 Apr 13.</citation>
    <PMID>15827765</PMID>
  </reference>
  <reference>
    <citation>Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.</citation>
    <PMID>28840147</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgery</keyword>
  <keyword>Testosterone</keyword>
  <keyword>Muscle atrophy</keyword>
  <keyword>Post-operative rehabilitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Atrophy</mesh_term>
    <mesh_term>Knee Injuries</mesh_term>
  </condition_browse>
  <!-- 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/NCT04456530
org study id: SRF-030
nct id: NCT04456530
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in
      patient's ability to return to activities. Although the use of testosterone in aging and
      chronic muscle loss has been investigated, this study could prove short-term use of
      testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by
      bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical
      quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM)
      testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and
      manual measurements of quadriceps cross-section.
This is an in vivo study using serial IM testosterone undeconate injections in participants
      undergoing knee surgery with limited weight bearing post-operatively which includes
      partial/total knee replacement, ACL reconstruction/revision, meniscal allograft
      transplantation and articular cartilage paste grafting. The design is a randomized,
      controlled, double blind, longitudinal study of intra-muscular injections of testosterone
      versus saline control. Pre-operative and post-operative assessments will include: serial MRIs
      and manual measurements of quadriceps cross-section and knee pain and function survey, KOOS.
      Blood analysis will be performed for therapeutic assessment and safety. The participant will
      receive two testosterone undeconate injections, once during their pre-operative visit and
      once during their 1 month visit. Timing of assessments will be pre-operative, 1-4 days
      post-operative and 1, 3, and 6 months. Measurement of the control group versus experimental
      group at all time points may identify differences in participant response to testosterone
      injections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: Both the participant and analyzing MRI Radiologist will be blind.
measure: Change in MRI Cross Sectional Area of the Quadriceps
time frame: Pre-operative and 1, 3, and 6 months post-operative
description: T1 Axial and Sagittal planes will be obtained using a ONI 1.0T extremity MRI. Axial Cross sectional Area (cm^2) will be measured of the Quadriceps muscle.
measure: Change in Manual Measurements of the Quadriceps
time frame: Pre-operative and 1, 3, and 6 months post-operative
description: Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape.
measure: Change in Knee Pain and Function Survey, KOOS
time frame: Pre-operative and 1, 3, and 6 months post-operative
description: Evaluate the knee pain and function of subjects as measures by the KOOS assessment.
Sections:
Pain
Symptoms
Activities of Daily Living
Sports and Recreation
Quality of Life
Scoring:
Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
measure: Change in serum cortisol (mcg/dL) levels
time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
description: Laboratory blood analysis of cortisol will be performed for therapeutic assessment and safety.
measure: Change in serum testosterone (ng/dL) levels
time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
description: Laboratory blood analysis of testosterone will be performed for therapeutic assessment and safety.
measure: Change in serum prostate specific antigen (ng/mL) levels
time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
description: Laboratory blood analysis of PSA will be performed for therapeutic assessment and safety.
measure: Change in serum hepatic function panel (mg/dL) levels
time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
description: Laboratory blood analysis of HFP will be performed for therapeutic assessment and safety.
measure: Change in complete blood count with differential levels
time frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
description: Laboratory blood analysis CBC w/ diff will be performed for therapeutic assessment and safety.
arm group label: Testosterone Group
arm group type: Experimental
description: Participants receiving two IM Testosterone injections.
arm group label: Control Group
arm group type: Placebo Comparator
description: Participants receiving two IM Normal Saline Injections.
intervention type: Drug
intervention name: Aveed 750 MG in 3 ML IM Injection
description: Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.
arm group label: Testosterone Group
intervention type: Other
intervention name: Normal Saline 3 ML IM Injection
description: Participants in the Control Group will receive two IM normal saline injections 1 month apart.
arm group label: Control Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mani Vessal, Ph.D.
role: Study Director
affiliation: Stone Research Foundation
facility: 
country: United States
url: https://www.endo.com/File%20Library/Products/Prescribing%20Information/AVEED_prescribing_information.html
description: Aveed Prescribing Information
citation: Bassil N, Alkaade S, Morley JE. The benefits and risks of testosterone replacement therapy: a review. Ther Clin Risk Manag. 2009 Jun;5(3):427-48. doi: 10.2147/tcrm.s3025. Epub 2009 Jun 22.
PMID: 19707253
citation: Nicholas JJ, Taylor FH, Buckingham RB, Ottonello D. Measurement of circumference of the knee with ordinary tape measure. Ann Rheum Dis. 1976 Jun;35(3):282-4. doi: 10.1136/ard.35.3.282.
PMID: 984911
citation: Arangio GA, Chen C, Kalady M, Reed JF 3rd. Thigh muscle size and strength after anterior cruciate ligament reconstruction and rehabilitation. J Orthop Sports Phys Ther. 1997 Nov;26(5):238-43. doi: 10.2519/jospt.1997.26.5.238.
PMID: 9353686
citation: Marcon M, Ciritsis B, Laux C, Nanz D, Nguyen-Kim TD, Fischer MA, Andreisek G, Ulbrich EJ. Cross-sectional area measurements versus volumetric assessment of the quadriceps femoris muscle in patients with anterior cruciate ligament reconstructions. Eur Radiol. 2015 Feb;25(2):290-8. doi: 10.1007/s00330-014-3424-2. Epub 2014 Oct 31.
PMID: 25358592
citation: Ruhdorfer AS, Dannhauer T, Wirth W, Cotofana S, Roemer F, Nevitt M, Eckstein F; OAI investigators. Thigh muscle cross-sectional areas and strength in knees with early vs knees without radiographic knee osteoarthritis: a between-knee, within-person comparison. Osteoarthritis Cartilage. 2014 Oct;22(10):1634-8. doi: 10.1016/j.joca.2014.06.002.
PMID: 25278072
citation: Orgiu S, Lafortuna CL, Rastelli F, Cadioli M, Falini A, Rizzo G. Automatic muscle and fat segmentation in the thigh from T1-Weighted MRI. J Magn Reson Imaging. 2016 Mar;43(3):601-10. doi: 10.1002/jmri.25031. Epub 2015 Aug 13.
PMID: 26268693
citation: Hartgens F, Kuipers H. Effects of androgenic-anabolic steroids in athletes. Sports Med. 2004;34(8):513-54. doi: 10.2165/00007256-200434080-00003.
PMID: 15248788
citation: Irrgang JJ, Ho H, Harner CD, Fu FH. Use of the International Knee Documentation Committee guidelines to assess outcome following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 1998;6(2):107-14. doi: 10.1007/s001670050082.
PMID: 9604196
citation: Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.
PMID: 1285753
citation: Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x.
PMID: 12366624
citation: Griggs RC, Kingston W, Jozefowicz RF, Herr BE, Forbes G, Halliday D. Effect of testosterone on muscle mass and muscle protein synthesis. J Appl Physiol (1985). 1989 Jan;66(1):498-503. doi: 10.1152/jappl.1989.66.1.498.
PMID: 2917954
citation: Akima H, Furukawa T. Atrophy of thigh muscles after meniscal lesions and arthroscopic partial menisectomy. Knee Surg Sports Traumatol Arthrosc. 2005 Nov;13(8):632-7. doi: 10.1007/s00167-004-0602-9. Epub 2005 Apr 13.
PMID: 15827765
citation: Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.
PMID: 28840147
responsible party type: Sponsor
mesh term: Muscular Atrophy
mesh term: Atrophy
mesh term: Knee Injuries