Rotator Cuff Injury
Conditions
Keywords
rotator cuff repair, Doxycycline
Brief summary
The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.
Detailed description
Basic Science small animal model data indicates that matrix metalloproteinase (MMP) inhibition via doxycycline results in improved early rotator cuff repair biomechanics and histology. Rotator cuff repair failure and retear is a significant clinical problem. The effects of MMP inhibition on human rotator cuff tear repair healing and outcomes is unknown, but may potentially improve healing rates and outcomes. Our purpose is to evaluate the effects of early oral doxycycline on healing and outcomes following arthroscopic rotator cuff repair.
Interventions
DRUGDoxycycline
antibiotic used to treat infection
DRUGsugar pill
placebo with no pharmacologic effect
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* repair of rotator cuff * age 18 and above * able to swallow capsules
Exclusion criteria
* less than 18 * unable to read or understand consent form * unable to swallow capsules * allergy to doxycycline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rotator cuff ultrasound of post-operative shoulder | one year | An ultrasound of the post-operative rotator cuff to assess level of healing or defect present. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons score | 6 weeks, 3mos, 6mos, 1yr and 2 yr. | The survey is a standardized assessment of shoulder pain and function from the patient's perspective. |
Countries
United States
Outcome results
None listed