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Recruitment difficulties
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Oxandrolone |
|
| Placebo Group | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxandrolone | Drug | Treatment group will receive Oxandrolone daily for 12 weeks postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in structural integrity of the rotator cuff/tendon healing | assessed by MRI, classified based on the Sugaya classification and Goutallier Grade | baseline to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in ASES shoulder score | American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire | baseline to 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in VAS pain scale | Visual Analog Score - pain scale, patient questionnaire | baseline to 104 weeks |
| change in PASS Score | Patient Acceptable Symptom State, patient questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George R Hatch, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck School of Medicine of the University of Southern California | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12796576 | Background | 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. | |
| 17717439 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2017 | Sep 14, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2017 | Sep 14, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D010074 | Oxandrolone |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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.
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Allocation will be performed using computer software and will occur at the pharmacy to ensure that all investigators are blinded.
| Placebo | Drug | Placebo group will receive placebo for 12 weeks postoperative |
|
| baseline to 104 weeks |
| change in Functional Outcome - Shoulder Strength | isometric shoulder strength measures using a handheld dynamometer | baseline to 104 weeks |
| change in Body Composition | body composition testing by bioelectric impedence | baseline to 104 weeks |
| 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. |
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| D011083 |
| Polycyclic Compounds |