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Trial of the Use of Doxycycline After Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT02388477
Recruitment Status : Withdrawn (Research idea tabled at this point.)
First Posted : March 17, 2015
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
Aman Dhawan, MD, 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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Injury Drug: Doxycycline Drug: sugar pill Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Doxycycline
oral doxycycline, 2 weeks, twice a day,
Drug: Doxycycline
antibiotic used to treat infection
Other Names:
  • Oracea,
  • Doryx
  • Monodox
  • Vibra-Tabs
  • Morgidox
  • Periostat
  • Atridox
  • Ocudox
  • Alodox

Placebo Comparator: sugar pill
sugar pill, same size, shape, and color as comparator, twice a day for 2 weeks.
Drug: sugar pill
placebo with no pharmacologic effect




Primary Outcome Measures :
  1. rotator cuff ultrasound of post-operative shoulder [ Time Frame: one year ]
    An ultrasound of the post-operative rotator cuff to assess level of healing or defect present.


Secondary Outcome Measures :
  1. American Shoulder and Elbow Surgeons score [ Time Frame: 6 weeks, 3mos, 6mos, 1yr and 2 yr. ]
    The survey is a standardized assessment of shoulder pain and function from the patient's perspective.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388477


Locations
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United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Aman Dhawan, MD Milton S. Hershey Medical Center

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Responsible Party: Aman Dhawan, MD, Assistant Professor of Surgery, Orthopaedics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02388477     History of Changes
Other Study ID Numbers: STUDY00002143
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Keywords provided by Aman Dhawan, MD, Milton S. Hershey Medical Center:
rotator cuff repair
Doxycycline
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents