Trial of the Use of Doxycycline After Rotator Cuff Repair

NCT ID: NCT02388477

Last Updated: 2016-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Doxycycline

oral doxycycline, 2 weeks, twice a day,

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

antibiotic used to treat infection

sugar pill

sugar pill, same size, shape, and color as comparator, twice a day for 2 weeks.

Group Type PLACEBO_COMPARATOR

sugar pill

Intervention Type DRUG

placebo with no pharmacologic effect

Interventions

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Doxycycline

antibiotic used to treat infection

Intervention Type DRUG

sugar pill

placebo with no pharmacologic effect

Intervention Type DRUG

Other Intervention Names

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Oracea, Doryx Monodox Vibra-Tabs Morgidox Periostat Atridox Ocudox Alodox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Aman Dhawan, MD

Assistant Professor of Surgery, Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aman Dhawan, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

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Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00002143

Identifier Type: -

Identifier Source: org_study_id

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