Oxandrolone Rotator Cuff Trial

Rotator Cuff Tear Clinical Trial

— ORCT  

Official title:

Ability of Oral Steroid (Oxandrolone) to Halt Fatty Infiltration and Aid Rotator Cuff Healing: A Double-Blind, Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03091075
• Other study ID #: HS-17-00272
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2018
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 the healing process and restoring muscle mass.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 116
• Est. completion date: December 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• scheduled for rotator cuff repair
• failed nonoperative management of chronic, full thickness rotator cuff tears
• full thickness rotator cuff tear confirmed on MRI

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Drug:
• Oxandrolone
Treatment group will receive Oxandrolone daily for 12 weeks postoperatively
• Placebo
Placebo group will receive placebo for 12 weeks postoperative

Locations

Country	Name	City	State
United States	Keck School of Medicine of the University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (32)

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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. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change in VAS pain scale	Visual Analog Score - pain scale, patient questionnaire	baseline to 104 weeks
Other	change in PASS Score	Patient Acceptable Symptom State, patient questionnaire	baseline to 104 weeks
Other	change in Functional Outcome - Shoulder Strength	isometric shoulder strength measures using a handheld dynamometer	baseline to 104 weeks
Other	change in Body Composition	body composition testing by bioelectric impedence	baseline to 104 weeks
Primary	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
Secondary	change in ASES shoulder score	American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire	baseline to 104 weeks