NCT02388477

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 9, 2016

Status Verified

May 1, 2016

First QC Date

March 3, 2015

Last Update Submit

May 6, 2016

Conditions

Rotator Cuff Injury

Keywords

rotator cuff repairDoxycycline

Outcome Measures

Primary Outcomes (1)

  • rotator cuff ultrasound of post-operative shoulder

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

    one year

Secondary Outcomes (1)

  • American Shoulder and Elbow Surgeons score

    6 weeks, 3mos, 6mos, 1yr and 2 yr.

Study Arms (2)

Doxycycline

ACTIVE COMPARATOR

oral doxycycline, 2 weeks, twice a day,

Drug: Doxycycline

sugar pill

PLACEBO COMPARATOR

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

Drug: sugar pill

Interventions

DoxycyclineDRUG

antibiotic used to treat infection

Also known as: Oracea,, Doryx, Monodox, Vibra-Tabs, Morgidox, Periostat, Atridox, Ocudox, Alodox
Doxycycline
sugar pillDRUG

placebo with no pharmacologic effect

sugar pill

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • repair of rotator cuff
  • age 18 and above
  • able to swallow capsules

You may not qualify if:

  • less than 18
  • unable to read or understand consent form
  • unable to swallow capsules
  • allergy to doxycycline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

DoxycyclineSugars

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsCarbohydrates

Study Officials

  • Aman Dhawan, MD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery, Orthopaedics

Study Record Dates

First Submitted

March 3, 2015

First Posted

March 17, 2015

Primary Completion

May 1, 2016

Last Updated

May 9, 2016

Record last verified: 2016-05

Locations

US(1)