Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

Phase 3

• Conditions: Periprosthetic Infection; Oral Antibiotics; Revision Total Shoulder Arthroplasty
• Interventions: Drug: Doxycycline 100 MG Oral Tablet

• Registration Number: NCT04636125
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections. As an anaerobe, it usually needs a prolonged culture incubation time of up to 14 days for growth and the association between implant surgery and C. acnes infection is not always obvious. Unfortunately, prolonged incubation also increases the risk of false positive cultures in isolating organisms that may exist as a result of contamination. Given high rates of positive C. acnes cultures in cases of both primary and revision shoulder surgery, the ramifications of positive C. acnes cultures for clinical decision making remains uncertain.

The purpose of this study is to prospectively study the efficacy and side-effect profile of surgical treatment plus an oral antibiotic regiment for shoulder PJI with indolent organisms (C. acnes and CNS).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-24
• Study First Submitted: 2020-10-21
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-18
• Last Update Submitted: 2020-11-18
• Study First Posted: 2020-11-19
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-09-24
• Study Completion: 2021-09-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. all patients undergoing single-stage revision arthroplasty with all implants exchanged,
2. all patients undergoing single-stage revision arthroplasty with some implants retained,
3. all patients undergoing explantation of a shoulder arthroplasty and placement of an antibiotic spacer

Exclusion Criteria

1. patients with polymicrobial infection,
2. patients with infection by organisms other than P. acnes or Coagulase Negative Staphylococcus,
3. patients with clinical suspicion of infection but negative cultures,
4. patients with no preoperative or intraoperative signs of infection and only 1 positive culture.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Revision Total Shoulder Arthroplasty	Doxycycline 100 MG Oral Tablet	Routine cultures are taken at the time of surgery. All patients are seen by an Infectious Disease Specialist and placed on 2 weeks oral doxycycline 100 mg (or alternative based on allergy or sensitivity) pending culture results.

Primary Outcome Measures

Name	Time	Method
Rate of Postoperative Infections	1 year	The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics after revision shoulder surgery versus those treated with intravenous antibiotics after surgery

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States