Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI

Rothman Institute Orthopaedics

Status and phase: Unknown; Phase 3

Conditions: Periprosthetic Infection; Oral Antibiotics; Revision Total Shoulder Arthroplasty

Treatments: Drug: Doxycycline 100 MG Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04636125

SNAM18D.443

Details and patient eligibility

About

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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Revision Total Shoulder Arthroplasty

Other group

Description:

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.

Treatment:

Drug: Doxycycline 100 MG Oral Tablet