The Incidence and Incubation Period of False Positive Cultures in Shoulder Surgery

NCT02602548 | Completed

• 1 other identifier: 1407463823
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will describe the time point at which a positive culture from a patient who has undergone shoulder surgery should be treated as an infection versus a false positive result that should be disregarded. Intraoperative biopsies will be taken and cultured from 50 subjects who have undergone an "open" surgical procedure and 50 from subjects undergoing an arthroscopic procedure.

Conditions

Infection

Keywords

Propionibacterium acnes; shoulder surgery; infection

Outcome Measures

Primary Outcomes (1)

• Incidence of positive cultures

  28 days

Secondary Outcomes (1)

• Incubation time clarification for culture growth if it occurs

  Less than or equal to 28 days

Study Arms (2)

Open Shoulder Surgery

Culture

Other: Culture

Arthroscopic Shoulder Surgery

Culture

Other: Culture

Interventions

Culture OTHER

Specimens will be obtained and sent to the lab for cultures.

Arthroscopic Shoulder Surgery; Open Shoulder Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with mechanical problems associated with their shoulder who elect to undergo shoulder surgery

You may qualify if:

• Patients undergoing primary open and arthroscopic shoulder surgery in which there is a clear diagnosis of a mechanical problem that is felt to be amenable to surgical intervention and there is no suspicion of infection. Examples include, but are not limited to: rotator cuff tear, labral tear, instability, impingement, and osteoarthritis.

You may not qualify if:

• Prior shoulder surgery
• Prior glenohumeral injection within the last 6 months
• Systemic or shoulder inflammatory disorder
• Any clinical, imaging, or laboratory findings that raise suspicion of infection
• Minors
• Erythrocyte sedimentation rate (ESR) \>15 mm/hr for males less than 50 years old, \>20 mm/hr for males greater than 50 years old and females less than 50 years old, and \>30 mm/hr for females greater than 50 years old
• C reactive protein (CRP) \>1 mg/d,
• Procalcitonin (PCT) \>0.05 ng/ml.

Sponsors & Collaborators

• Forte Sports Medicine and Orthopedics: lead

Related Publications (2)

• Butler-Wu SM, Burns EM, Pottinger PS, Magaret AS, Rakeman JL, Matsen FA 3rd, Cookson BT. Optimization of periprosthetic culture for diagnosis of Propionibacterium acnes prosthetic joint infection. J Clin Microbiol. 2011 Jul;49(7):2490-5. doi: 10.1128/JCM.00450-11. Epub 2011 May 4.

  PMID: 21543562 BACKGROUND

• Levy O, Iyer S, Atoun E, Peter N, Hous N, Cash D, Musa F, Narvani AA. Propionibacterium acnes: an underestimated etiology in the pathogenesis of osteoarthritis? J Shoulder Elbow Surg. 2013 Apr;22(4):505-11. doi: 10.1016/j.jse.2012.07.007. Epub 2012 Sep 13.

  PMID: 22981447 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Culture Techniques

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• Gary Misamore, MD

  Forte Sports Medicine and Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: April 25, 2015
• First Posted: November 11, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share