Study Summary
This trial is testing a medication to see if it helps healing and restoring muscle mass after a rotator cuff repair.
Eligible Conditions
- Rotator Cuff Tears
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks
Week 104
change in structural integrity of the rotator cuff/tendon healing
Week 104
change in ASES shoulder score
change in Body Composition
change in Functional Outcome - Shoulder Strength
change in PASS Score
change in VAS pain scale
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Treatment Group
1 of 2
Placebo Group
1 of 2
Experimental Treatment
Non-Treatment Group
144 Total Participants · 2 Treatment Groups
Primary Treatment: Oxandrolone Pill · Has Placebo Group · Phase 2
Treatment Group
Drug
Experimental Group · 1 Intervention: Oxandrolone Pill · Intervention Types: DrugPlacebo Group
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
827 Previous Clinical Trials
1,419,870 Total Patients Enrolled
George R Hatch, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
12 Total Patients Enrolled
Eligibility Criteria
Age 40 - 75 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a full thickness rotator cuff tear on MRI.
References
- GERBER, CHRISTIAN, BRUNO FUCHS, and JUERG HODLER. 2000. “The Results of Repair of Massive Tears of the Rotator Cuff*†”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/00004623-200004000-00006.
- Le, Brian T.N., Xiao L. Wu, Patrick H. Lam, and George A.C. Murrell. 2014. “Factors Predicting Rotator Cuff Retears”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546514525336.
- Michener, Lori A., Alison R. Snyder, and Brian G. Leggin. 2011. “Responsiveness of the Numeric Pain Rating Scale in Patients with Shoulder Pain and the Effect of Surgical Status”. Journal of Sport Rehabilitation. Human Kinetics. doi:10.1123/jsr.20.1.115.
- Boileau, Pascal. 2005. “Arthroscopic Repair of Full-thickness Tears of the Supraspinatus: Does the Tendon Really Heal?”. The Journal of Bone and Joint Surgery (american). Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.d.02035.
- Björnsson, Hanna C, Rolf Norlin, Kajsa Johansson, and Lars E Adolfsson. 2011. “The Influence of Age, Delay of Repair, and Tendon Involvement in Acute Rotator Cuff Tears”. Acta Orthopaedica. Medical Journals Sweden AB. doi:10.3109/17453674.2011.566144.
- Patel, Sahishnu, Anthony P. Gualtieri, Helen H. Lu, and William N. Levine. 2016. “Advances in Biologic Augmentation for Rotator Cuff Repair”. Annals of the New York Academy of Sciences. Wiley. doi:10.1111/nyas.13267.
- Michener, Lori A.. 2011. “Patient- and Clinician-rated Outcome Measures for Clinical Decision Making in Rehabilitation”. Journal of Sport Rehabilitation. Human Kinetics. doi:10.1123/jsr.20.1.37.
- Colvin, Alexis Chiang, Natalia Egorova, Alicia K Harrison, Alan Moskowitz, and Evan L Flatow. 2012. “National Trends in Rotator Cuff Repair”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.j.00739.
- Wolf, Steven E., Steven J. Thomas, Mohan R. Dasu, Arny A. Ferrando, David L. Chinkes, Robert R. Wolfe, and David N. Herndon. 2003. “Improved Net Protein Balance, Lean Mass, and Gene Expression Changes with Oxandrolone Treatment in the Severely Burned”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.sla.0000071562.12637.3e.
- Jeschke, Marc G., Celeste C. Finnerty, Oscar E. Suman, Gabriela Kulp, Ronald P. Mlcak, and David N. Herndon. 2007. “The Effect of Oxandrolone on the Endocrinologic, Inflammatory, and Hypermetabolic Responses During the Acute Phase Postburn”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e318146980e.
- Schroeder, E. T., A. F. Vallejo, L. Zheng, Y. Stewart, C. Flores, S. Nakao, C. Martinez, and F. R. Sattler. 2005. “Six-week Improvements in Muscle Mass and Strength During Androgen Therapy in Older Men”. The Journals of Gerontology Series A: Biological Sciences and Medical Sciences. Oxford University Press (OUP). doi:10.1093/gerona/60.12.1586.
- Lee, Thay Q. 2013. “Current Biomechanical Concepts for Rotator Cuff Repair”. Clinics in Orthopedic Surgery. The Korean Orthopaedic Association. doi:10.4055/cios.2013.5.2.89.
- Gulotta, Lawrence V., David Kovacevic, John R. Ehteshami, Elias Dagher, Jonathan D. Packer, and Scott A. Rodeo. 2009. “Application of Bone Marrow-derived Mesenchymal Stem Cells in a Rotator Cuff Repair Model”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546509339582.
- Kelly, Bryan T., Warren R. Kadrmas, and Kevin P. Speer. 1996. “The Manual Muscle Examination for Rotator Cuff Strength”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/036354659602400504.
- Makhni, Eric C., Michael E. Steinhaus, Zachary S. Morrow, Charles M. Jobin, Nikhil N. Verma, Brian J. Cole, and Bernard R. Bach Jr.. 2015. “Outcomes Assessment in Rotator Cuff Pathology: What Are We Measuring?”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2015.08.007.
- Ruiz-Moneo, Pedro, Jorge Molano-Muñoz, Estrella Prieto, and Jaime Algorta. 2013. “Plasma Rich in Growth Factors in Arthroscopic Rotator Cuff Repair: A Randomized, Double-blind, Controlled Clinical Trial”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2012.08.014.
- Moraiti, Constantina, Pablo Valle, Ali Maqdes, Omar Boughebri, Chourky Dib, Giannis Giakas, Jean Kany, et al.. 2015. “Comparison of Functional Gains After Arthroscopic Rotator Cuff Repair in Patients over 70 Years of Age Versus Patients Under 50 Years of Age: A Prospective Multicenter Study”. Arthroscopy: The Journal of Arthroscopic & Related Surgery. Elsevier BV. doi:10.1016/j.arthro.2014.08.020.
- Sugaya, Hiroyuki, Kazuhiko Maeda, Keisuke Matsuki, and Joji Moriishi. 2007. “Repair Integrity and Functional Outcome After Arthroscopic Double-row Rotator Cuff Repair”. The Journal of Bone & Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.f.00512.
- Kim, H. Mike, Jon-Michael E. Caldwell, John A. Buza, Leslie A. Fink, Christopher S. Ahmad, Louis U. Bigliani, and William N. Levine. 2014. “Factors Affecting Satisfaction and Shoulder Function in Patients with a Recurrent Rotator Cuff Tear”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.l.01649.
- Richards, Robin R., Kai-Nan An, Louis U. Bigliani, Richard J. Friedman, Gary M. Gartsman, Anthony G. Gristina, Joseph P. Iannotti, Van C. Mow, John A. Sidles, and Joseph D. Zuckerman. 1994. “A Standardized Method for the Assessment of Shoulder Function”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/s1058-2746(09)80019-0.
- Mintken, Paul E., Amy W. McDevitt, Joshua A. Cleland, Robert E. Boyles, Amber R. Beardslee, Scott A. Burns, Matthew D. Haberl, Lauren A. Hinrichs, and Lori A. Michener. 2016. “Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals with Shoulder Pain: A Multicenter Randomized Controlled Trial”. Journal of Orthopaedic & Sports Physical Therapy. Journal of Orthopaedic & Sports Physical Therapy (JOSPT). doi:10.2519/jospt.2016.6319.
- GERBER, C., D. C. MEYER, A. G. SCHNEEBERGER, H. HOPPELER, and B. VON RECHENBERG. 2004. “Effect of Tendon Release and Delayed Repair on the Structure of the Muscles of the Rotator Cuff”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/00004623-200409000-00016.
- Gerber, C., D.C. Meyer, K.M. Nuss, and M. Farshad. 2011. “Anabolic Steroids Reduce Muscle Damage Caused by Rotator Cuff Tendon Release in an Experimental Study in Rabbits”. Journal of Bone and Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.j.01589.
- Meyer, Dominik C., Karl Wieser, Mazda Farshad, and Christian Gerber. 2012. “Retraction of Supraspinatus Muscle and Tendon as Predictors of Success of Rotator Cuff Repair”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546512457587.
- Ensor, Kelsey L., Young W. Kwon, Michael R. DiBeneditto, Joseph D. Zuckerman, and Andrew S. Rokito. 2013. “The Rising Incidence of Rotator Cuff Repairs”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2013.01.006.
- Gerber, Christian, Dominik C. Meyer, Martin Flück, Mario C. Benn, Brigitte von Rechenberg, and Karl Wieser. 2015. “Anabolic Steroids Reduce Muscle Degeneration Associated with Rotator Cuff Tendon Release in Sheep”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546515596411.
- Hertzog, Melody A.. 2008. “Considerations in Determining Sample Size for Pilot Studies”. Research in Nursing & Health. Wiley. doi:10.1002/nur.20247.
- Vitale, Mark A., Michael G. Vitale, Joshua G. Zivin, Jonathan P. Braman, Louis U. Bigliani, and Evan L. Flatow. 2007. “Rotator Cuff Repair: An Analysis of Utility Scores and Cost-effectiveness”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2006.06.013.
- Galatz, Leesa M., Craig M. Ball, Sharlene A. Teefey, William D. Middleton, and Ken Yamaguchi. 2004. “The Outcome and Repair Integrity of Completely Arthroscopically Repaired Large and Massive Rotator Cuff Tears”. The Journal of Bone & Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/00004623-200402000-00002.
- Melis, B., C. Nemoz, and G. Walch. 2009. “Muscle Fatty Infiltration in Rotator Cuff Tears: Descriptive Analysis of 1688 Cases”. Orthopaedics & Traumatology: Surgery & Research. Elsevier BV. doi:10.1016/j.otsr.2009.05.001.
- Yamaguchi, Ken, Konstantinos Ditsios, William D. Middleton, Charles F. Hildebolt, Leesa M. Galatz, and Sharlene A. Teefey. 2006. “The Demographic and Morphological Features of Rotator Cuff Disease”. The Journal of Bone & Joint Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.e.00835.
- Rodeo, Scott A., Demetris Delos, Riley J. Williams, Ronald S. Adler, Andrew Pearle, and Russell F. Warren. 2012. “The Effect of Platelet-rich Fibrin Matrix on Rotator Cuff Tendon Healing”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546512442924.
- Melis, B., C. Nemoz, and G. Walch. 2009. “Muscle Fatty Infiltration in Rotator Cuff Tears: Descriptive Analysis of 1688 Cases”. Orthopaedics & Traumatology: Surgery & Research. Elsevier BV. doi:10.1016/j.otsr.2009.05.001.
- Vitale, Mark A., Michael G. Vitale, Joshua G. Zivin, Jonathan P. Braman, Louis U. Bigliani, and Evan L. Flatow. 2007. “Rotator Cuff Repair: An Analysis of Utility Scores and Cost-effectiveness”. Journal of Shoulder and Elbow Surgery. Elsevier BV. doi:10.1016/j.jse.2006.06.013.
- Vitale MA, Vitale MG, Zivin JG, Braman JP, Bigliani LU, Flatow EL. Rotator cuff repair: an analysis of utility scores and cost-effectiveness. J Shoulder Elbow Surg. 2007 Mar-Apr;16(2):181-7. doi: 10.1016/j.jse.2006.06.013.
- Michener LA, Snyder AR, Leggin BG. Responsiveness of the numeric pain rating scale in patients with shoulder pain and the effect of surgical status. J Sport Rehabil. 2011 Feb;20(1):115-28. doi: 10.1123/jsr.20.1.115.
- Galatz LM, Ball CM, Teefey SA, Middleton WD, Yamaguchi K. The outcome and repair integrity of completely arthroscopically repaired large and massive rotator cuff tears. J Bone Joint Surg Am. 2004 Feb;86(2):219-24. doi: 10.2106/00004623-200402000-00002.
- Yamaguchi K, Ditsios K, Middleton WD, Hildebolt CF, Galatz LM, Teefey SA. The demographic and morphological features of rotator cuff disease. A comparison of asymptomatic and symptomatic shoulders. J Bone Joint Surg Am. 2006 Aug;88(8):1699-704. doi: 10.2106/JBJS.E.00835.
- Kelly BT, Kadrmas WR, Speer KP. The manual muscle examination for rotator cuff strength. An electromyographic investigation. Am J Sports Med. 1996 Sep-Oct;24(5):581-8. doi: 10.1177/036354659602400504.
- Michener LA. Patient- and clinician-rated outcome measures for clinical decision making in rehabilitation. J Sport Rehabil. 2011 Feb;20(1):37-45. doi: 10.1123/jsr.20.1.37.
- Wolf SE, Thomas SJ, Dasu MR, Ferrando AA, Chinkes DL, Wolfe RR, Herndon DN. Improved net protein balance, lean mass, and gene expression changes with oxandrolone treatment in the severely burned. Ann Surg. 2003 Jun;237(6):801-10; discussion 810-1. doi: 10.1097/01.SLA.0000071562.12637.3E.
- Patel S, Gualtieri AP, Lu HH, Levine WN. Advances in biologic augmentation for rotator cuff repair. Ann N Y Acad Sci. 2016 Nov;1383(1):97-114. doi: 10.1111/nyas.13267. Epub 2016 Oct 17.
- Ruiz-Moneo P, Molano-Munoz J, Prieto E, Algorta J. Plasma rich in growth factors in arthroscopic rotator cuff repair: a randomized, double-blind, controlled clinical trial. Arthroscopy. 2013 Jan;29(1):2-9. doi: 10.1016/j.arthro.2012.08.014.
- Moraiti C, Valle P, Maqdes A, Boughebri O, Dib C, Giakas G, Kany J, Elkholti K, Garret J, Katz D, Leclere FM, Valenti P. Comparison of functional gains after arthroscopic rotator cuff repair in patients over 70 years of age versus patients under 50 years of age: a prospective multicenter study. Arthroscopy. 2015 Feb;31(2):184-90. doi: 10.1016/j.arthro.2014.08.020. Epub 2014 Nov 11.
- Boileau P, Brassart N, Watkinson DJ, Carles M, Hatzidakis AM, Krishnan SG. Arthroscopic repair of full-thickness tears of the supraspinatus: does the tendon really heal? J Bone Joint Surg Am. 2005 Jun;87(6):1229-40. doi: 10.2106/JBJS.D.02035.
- Meyer DC, Wieser K, Farshad M, Gerber C. Retraction of supraspinatus muscle and tendon as predictors of success of rotator cuff repair. Am J Sports Med. 2012 Oct;40(10):2242-7. doi: 10.1177/0363546512457587. Epub 2012 Aug 27.
- Makhni EC, Steinhaus ME, Morrow ZS, Jobin CM, Verma NN, Cole BJ, Bach BR Jr. Outcomes assessment in rotator cuff pathology: what are we measuring? J Shoulder Elbow Surg. 2015 Dec;24(12):2008-15. doi: 10.1016/j.jse.2015.08.007. Epub 2015 Oct 21.
- Gerber C, Fuchs B, Hodler J. The results of repair of massive tears of the rotator cuff. J Bone Joint Surg Am. 2000 Apr;82(4):505-15. doi: 10.2106/00004623-200004000-00006.
- Jeschke MG, Finnerty CC, Suman OE, Kulp G, Mlcak RP, Herndon DN. The effect of oxandrolone on the endocrinologic, inflammatory, and hypermetabolic responses during the acute phase postburn. Ann Surg. 2007 Sep;246(3):351-60; discussion 360-2. doi: 10.1097/SLA.0b013e318146980e.
- Sugaya H, Maeda K, Matsuki K, Moriishi J. Repair integrity and functional outcome after arthroscopic double-row rotator cuff repair. A prospective outcome study. J Bone Joint Surg Am. 2007 May;89(5):953-60. doi: 10.2106/JBJS.F.00512.
- Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
- Gerber C, Meyer DC, Schneeberger AG, Hoppeler H, von Rechenberg B. Effect of tendon release and delayed repair on the structure of the muscles of the rotator cuff: an experimental study in sheep. J Bone Joint Surg Am. 2004 Sep;86(9):1973-82. doi: 10.2106/00004623-200409000-00016.
- Schroeder ET, Vallejo AF, Zheng L, Stewart Y, Flores C, Nakao S, Martinez C, Sattler FR. Six-week improvements in muscle mass and strength during androgen therapy in older men. J Gerontol A Biol Sci Med Sci. 2005 Dec;60(12):1586-92. doi: 10.1093/gerona/60.12.1586.
- Bjornsson HC, Norlin R, Johansson K, Adolfsson LE. The influence of age, delay of repair, and tendon involvement in acute rotator cuff tears: structural and clinical outcomes after repair of 42 shoulders. Acta Orthop. 2011 Apr;82(2):187-92. doi: 10.3109/17453674.2011.566144. Epub 2011 Mar 24.
- Gerber C, Meyer DC, Fluck M, Benn MC, von Rechenberg B, Wieser K. Anabolic Steroids Reduce Muscle Degeneration Associated With Rotator Cuff Tendon Release in Sheep. Am J Sports Med. 2015 Oct;43(10):2393-400. doi: 10.1177/0363546515596411. Epub 2015 Aug 24.
- Frank Petrigliano 2018. "Oxandrolone Rotator Cuff Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03091075.
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