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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone Group | Experimental | Participants receiving two IM Testosterone injections. |
|
| Control Group | Placebo Comparator | Participants receiving two IM Normal Saline Injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aveed 750 MG in 3 ML IM Injection | Drug | Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in MRI Cross Sectional Area of the Quadriceps | 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. | Pre-operative and 1, 3, and 6 months post-operative |
| Change in Manual Measurements of the Quadriceps | Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape. | Pre-operative and 1, 3, and 6 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Pain and Function Survey, KOOS | Evaluate the knee pain and function of subjects as measures by the KOOS assessment. Sections:
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 | Description | Time Frame |
|---|---|---|
| Change in serum cortisol (mcg/dL) levels | Laboratory blood analysis of cortisol will be performed for therapeutic assessment and safety. | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative |
| Change in serum testosterone (ng/dL) levels |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mani Vessal, Ph.D. | Stone Research Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stone Research Foundation | San Francisco | California | 94123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19707253 | Background | 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. | |
| 984911 | Background | 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. |
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Both the participant and analyzing MRI Radiologist will be blind.
| Normal Saline 3 ML IM Injection | Other | Participants in the Control Group will receive two IM normal saline injections 1 month apart. |
|
| Pre-operative and 1, 3, and 6 months post-operative |
Laboratory blood analysis of testosterone will be performed for therapeutic assessment and safety. |
| Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative |
| Change in serum prostate specific antigen (ng/mL) levels | Laboratory blood analysis of PSA will be performed for therapeutic assessment and safety. | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative |
| Change in serum hepatic function panel (mg/dL) levels | Laboratory blood analysis of HFP will be performed for therapeutic assessment and safety. | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative |
| Change in complete blood count with differential levels | Laboratory blood analysis CBC w/ diff will be performed for therapeutic assessment and safety. | Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative |
| 9353686 | Background | 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. |
| 25358592 | Background | 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. |
| 25278072 | Background | 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. |
| 26268693 | Background | 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. |
| 15248788 | Background | Hartgens F, Kuipers H. Effects of androgenic-anabolic steroids in athletes. Sports Med. 2004;34(8):513-54. doi: 10.2165/00007256-200434080-00003. |
| 9604196 | Background | 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. |
| 1285753 | Background | 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. |
| 12366624 | Background | 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. |
| 2917954 | Background | 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. |
| 15827765 | Background | 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. |
| 28840147 | Background | 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. |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D007718 | Knee Injuries |
| D004194 | Disease |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D007869 | Leg Injuries |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D043343 | Testosterone Propionate |
| D007273 | Injections, Intramuscular |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013739 | Testosterone |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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