Trial of the Use of Doxycycline After Rotator Cuff Repair

Rotator Cuff Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02388477
• Other study ID #: STUDY00002143
• Status: Withdrawn
• Phase: N/A
• First received: March 3, 2015
• Last updated: May 6, 2016

Study information

• Verified date: May 2016
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Injury

Intervention

Drug:
• Doxycycline
antibiotic used to treat infection
• sugar pill
placebo with no pharmacologic effect

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	American Shoulder and Elbow Surgeons score	The survey is a standardized assessment of shoulder pain and function from the patient's perspective.	6 weeks, 3mos, 6mos, 1yr and 2 yr.	No