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Trial of the Use of Doxycycline After Rotator Cuff Repair

Primary Purpose

Rotator Cuff Injury

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
sugar pill
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injury focused on measuring rotator cuff repair, Doxycycline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Doxycycline

sugar pill

Arm Description

oral doxycycline, 2 weeks, twice a day,

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

American Shoulder and Elbow Surgeons score
The survey is a standardized assessment of shoulder pain and function from the patient's perspective.

Full Information

First Posted
March 3, 2015
Last Updated
May 6, 2016
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02388477
Brief Title
Trial of the Use of Doxycycline After Rotator Cuff Repair
Official Title
Randomized Controlled Trial of the Use of Doxycycline After Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Research idea tabled at this point.
Study Start Date
undefined (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injury
Keywords
rotator cuff repair, Doxycycline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline
Arm Type
Active Comparator
Arm Description
oral doxycycline, 2 weeks, twice a day,
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
sugar pill, same size, shape, and color as comparator, twice a day for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Oracea,, Doryx, Monodox, Vibra-Tabs, Morgidox, Periostat, Atridox, Ocudox, Alodox
Intervention Description
antibiotic used to treat infection
Intervention Type
Drug
Intervention Name(s)
sugar pill
Intervention Description
placebo with no pharmacologic effect
Primary Outcome Measure Information:
Title
rotator cuff ultrasound of post-operative shoulder
Description
An ultrasound of the post-operative rotator cuff to assess level of healing or defect present.
Time Frame
one year
Secondary Outcome Measure Information:
Title
American Shoulder and Elbow Surgeons score
Description
The survey is a standardized assessment of shoulder pain and function from the patient's perspective.
Time Frame
6 weeks, 3mos, 6mos, 1yr and 2 yr.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aman Dhawan, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Trial of the Use of Doxycycline After Rotator Cuff Repair

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