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NCT03849885 | RECRUITING | Degenerative Osteoarthritis

Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
Sponsor:

Colorado Joint Replacement

Brief Summary:

This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium, more specifically P acnes, the same bacterium that is responsible for the majority of acne. Information affecting hip surgery is currently unknown.

Condition or disease

Degenerative Osteoarthritis

Intervention/treatment

Benzoyl peroxide gel

Phase

PHASE4

Detailed Description:

This study is being done to investigate the colonization rate(growth rate) of a particular type of low-virulence (does not typically cause infection) bacterium called Propionibacterium. The most common bacterium of this family is P acnes, the same bacterium that is responsible for the majority of acne. There is increasing evidence that infection with P acnes and other Propionibacterium is a significant source of failure following certain orthopaedic shoulder procedures. However, information affecting hip surgery is currently unknown. Our personal experience leads us to believe that the numbers are actually quite high, since we are seeing an increased rate of Propionibacterium infection of hip replacement in the community. However, this type of study has never been done before, and therefore we simply do not know an accurate estimate for the average hip replacement patient's risk for Propionibacterium infection following hip replacement.

Study Type : INTERVENTIONAL
Estimated Enrollment : 496 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty
Actual Study Start Date : 2019-02-02
Estimated Primary Completion Date : 2023-12-31
Estimated Study Completion Date : 2024-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Patients who are 18 to 79 85 years of age
  • * CJR primary joint arthroplasty patients who are receiving care at Porter Adventist Hospital
  • * CJR established primary knee or hip arthroplasty patients with a native hip joint (no replacement on the biopsy side) who volunteers as a research participant.
  • * CJR patients without a previous arthroplasty procedure who have established care with our practice.
Exclusion Criteria
  • * Previous history of hip infection
  • * Current antibiotic use or antibiotic use within the past week
  • * Previous history of Cutibacterium joint infection
  • * Current immunodeficiency disease or disorder
  • * Patients with active psoriatic disease or other focal inflammation over the hip
  • * Previous total hip arthroplasty (bilateral for the case of TKA patients and healthy volunteers, contralateral for THA patients)
Cutibacterium Dermal Colonization: Implications for Total Hip Arthroplasty

Location Details

NCT03849885

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How to Participate

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Locations

RECRUITING

United States, Colorado

Colorado Joint Replacement

Denver, Colorado, United States, 80210