MedPath

Trial of the Use of Doxycycline After Rotator Cuff Repair

Not Applicable
Withdrawn
Conditions
Rotator Cuff Injury
Interventions
Drug: sugar pill
Registration Number
NCT02388477
Lead Sponsor
Milton S. Hershey Medical Center
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
sugar pillsugar pillsugar pill, same size, shape, and color as comparator, twice a day for 2 weeks.
DoxycyclineDoxycyclineoral doxycycline, 2 weeks, twice a day,
Primary Outcome Measures
NameTimeMethod
rotator cuff ultrasound of post-operative shoulderone year

An ultrasound of the post-operative rotator cuff to assess level of healing or defect present.

Secondary Outcome Measures
NameTimeMethod
American Shoulder and Elbow Surgeons score6 weeks, 3mos, 6mos, 1yr and 2 yr.

The survey is a standardized assessment of shoulder pain and function from the patient's perspective.

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center

🇺🇸

Hershey, Pennsylvania, United States

© Copyright 2025. All Rights Reserved by MedPath