Trial of the Use of Doxycycline After Rotator Cuff Repair

May 6, 2016 updated by: Aman Dhawan, MD, Milton S. Hershey Medical Center

Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair

The purpose of this study is to examine healing after rotator cuff repair in subjects either treated with Doxycycline or placebo post-operatively.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Doxycycline
oral doxycycline, 2 weeks, twice a day,
Drug: Doxycycline
antibiotic used to treat infection
Other Names:
  • Doryx
  • Monodox
  • Periostat
  • Vibra-Tabs
  • Oracea,
  • Morgidox
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks, 3mos, 6mos, 1yr and 2 yr.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Aman Dhawan, MD, Milton S. Hershey Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

March 3, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2016

Last Update Submitted That Met QC Criteria

May 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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