Rotator Cuff TearORCTNCT03091075
Oxandrolone Rotator Cuff Trial
A study testing Oxandrolone in people with Rotator Cuff Tear, run by University of Southern California at 1 site in United States.
Trial summary
This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Oxandrolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2018to 6 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for rotator cuff repair
- failed nonoperative management of chronic, full thickness rotator cuff tears
- full thickness rotator cuff tear confirmed on MRI
Who cannot join
- patients with prior shoulder surgery or prior rotator cuff repair
- tears larger than 5 cm
- significant glenohumeral arthritis (Hamada Grade 2 or higher)
- Untreated diabetes mellitus
- Pituitary tumor
- Rheumatoid arthritis
Show all 23Show fewer
- Uncontrolled hypertension
- Congestive heart failure
- Myocardial infarction within the past 6 months
- End-stage renal disease
- Liver enzymes two times the normal value
- Deep Vein Thrombosis (DVT) within the past 6 months
- Disorder of the coagulation system
- Currently taking anticoagulation
- Claustrophobia
- Prior or current use of anabolic steroids
- Chromosomal disorders
- Prostate cancer
- Breast cancer
- Hypercalcemia
- Medications that interfere with testosterone production or function, including but not limited to 5 alpha-reductase inhibitors
- Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 6 weeks after the last dose of study treatment
- Any other condition or treatment interfering with completion of the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033
About this study
Official title: Ability of Oral Steroid (Oxandrolone) to Halt Fatty Infiltration and Aid Rotator Cuff Healing: A Double-Blind, Randomized Clinical Trial
This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.
- Conditions
- Rotator Cuff Tear
- Being tested
- Oxandrolone, Placebo
- Keywords
- Rotator Cuff Tear, Rotator Cuff, Anabolic Steroid, Testosterone, Oxandrolone
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxandroloneDrug
Treatment group will receive Oxandrolone daily for 12 weeks postoperatively
PlaceboDrug
Placebo group will receive placebo for 12 weeks postoperative
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Oxandrolone Receives: Drug: Oxandrolone |
| Placebo Group | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in structural integrity of the rotator cuff/tendon healing
assessed by MRI, classified based on the Sugaya classification and Goutallier Grade
Measured: baseline to 52 weeks
Secondary outcomes (1)
change in ASES shoulder score
American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire
Measured: baseline to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start23 Sep 2018
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Men and women aged 40 - 75 scheduled for rotator cuff repair, who have failed nonoperative management of chronic, full thickness rotator cuff tears confirmed by MRI, will be randomized into one of two groups, a control group (receiving placebo medication) and an experimental group receiving oral Oxandrolone for 12 weeks postoperative.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George F. Hatch, University of Southern California
- Investigators
- George R Hatch, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091075
- Sponsor's protocol ID
- HS-17-00272
- Acronym
- ORCT
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2017
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12796576Jeschke 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.
PubMed 17717439Schroeder 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.
PubMed 16424293Gerber 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.
PubMed 10761941Meyer 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.
PubMed 22926748Sugaya 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.
PubMed 17473131Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop Relat Res. 1994 Jul;(304):78-83.
PubMed 8020238Le BT, Wu XL, Lam PH, Murrell GA. Factors predicting rotator cuff retears: an analysis of 1000 consecutive rotator cuff repairs. Am J Sports Med. 2014 May;42(5):1134-42. doi: 10.1177/0363546514525336. Epub 2014 Apr 18.
PubMed 24748610Kim HM, Caldwell JM, Buza JA, Fink LA, Ahmad CS, Bigliani LU, Levine WN. Factors affecting satisfaction and shoulder function in patients with a recurrent rotator cuff tear. J Bone Joint Surg Am. 2014 Jan 15;96(2):106-12. doi: 10.2106/JBJS.L.01649.
PubMed 24430409Kelly 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.
PubMed 8883676Makhni 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.
PubMed 26475640Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
PubMed 22958838Michener 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.
PubMed 21411827Michener 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.
PubMed 21411821Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.
PubMed 27477473
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Oral Steroid (Oxandrolone) to Halt Fatty Infiltration and Aid Rotator Cuff Healing: A Double-Blind, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03091075
- Acronym / sponsor ID
- ORCT / HS-17-00272
- Conditions
- Rotator Cuff Tear
- Keywords
- Rotator Cuff Tear, Rotator Cuff, Anabolic Steroid, Testosterone, Oxandrolone
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Men and women aged 40 - 75 scheduled for rotator cuff repair, who have failed nonoperative management of chronic, full thickness rotator cuff tears confirmed by MRI, will be randomized into one of two groups, a control group (receiving placebo medication) and an experimental group receiving oral Oxandrolone for 12 weeks postoperative.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: OxandroloneOxandrolone |
| Placebo Group | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- scheduled for rotator cuff repair
- failed nonoperative management of chronic, full thickness rotator cuff tears
- full thickness rotator cuff tear confirmed on MRI
Key exclusion criteria (23 listed)
- patients with prior shoulder surgery or prior rotator cuff repair
- tears larger than 5 cm
- significant glenohumeral arthritis (Hamada Grade 2 or higher)
- Untreated diabetes mellitus
- Pituitary tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxandroloneTreatment group will receive Oxandrolone daily for 12 weeks postoperatively | Drug | Treatment Group |
| PlaceboPlacebo group will receive placebo for 12 weeks postoperative | Drug | Placebo Group |
Primary outcome
change in structural integrity of the rotator cuff/tendon healing
Time frame: baseline to 52 weeks
assessed by MRI, classified based on the Sugaya classification and Goutallier Grade
1 secondary outcome
change in ASES shoulder score
Time frame: baseline to 104 weeks
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 12796576Wolf 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.
- Background: PubMed 17717439Jeschke 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.
- Background: PubMed 16424293Schroeder 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.
- Background: PubMed 10761941Gerber 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.
- Background: PubMed 22926748Meyer 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.
- Background: PubMed 17473131Sugaya 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.
- Background: PubMed 8020238Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop Relat Res. 1994 Jul;(304):78-83.
- Background: PubMed 24748610Le BT, Wu XL, Lam PH, Murrell GA. Factors predicting rotator cuff retears: an analysis of 1000 consecutive rotator cuff repairs. Am J Sports Med. 2014 May;42(5):1134-42. doi: 10.1177/0363546514525336. Epub 2014 Apr 18.
- Background: PubMed 24430409Kim HM, Caldwell JM, Buza JA, Fink LA, Ahmad CS, Bigliani LU, Levine WN. Factors affecting satisfaction and shoulder function in patients with a recurrent rotator cuff tear. J Bone Joint Surg Am. 2014 Jan 15;96(2):106-12. doi: 10.2106/JBJS.L.01649.
- Background: PubMed 8883676Kelly 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.
- Background: PubMed 26475640Makhni 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.
- Background: PubMed 22958838Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George R Hatch, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxandrolone in people with Rotator Cuff Tear, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in structural integrity of the rotator cuff/tendon healing (time frame: baseline to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091075, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.