Surgical Field Bacterial Contamination in Primary Total H... | NCT01493375

Studies
Surgical Field Bacterial Contamination in Primary Total Hip (THA) and Knee (TKA) Arthroplasty

NCT01493375

Sponsor

Northern Orthopaedic Division, Denmark

Status

Suspended

Last Update Posted

May 28, 2015Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Prosthetic Infections

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study principal investigator left the organization

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Dec 2010Actual

Completion Date

Not provided

First Submitted Date

Dec 14, 2011

First Submission Date that Met QC Criteria

Dec 14, 2011

First Posted Date

Dec 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 28, 2015Estimated

Name	Class
Aarhus University Hospital	OTHER
University of Aarhus	OTHER
Aalborg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In Denmark, approximately 13,000 operations are carried out every year. Prosthetic infection is a very serious condition and despite extensive prophylactic measures, prosthetic infections appear in 1-2 percent of the operated patients.

It is difficult to diagnose prosthetic infection with the techniques applied so far and incorrect diagnosis might imply unnecessary reoperations as well as unnoticed infections might lead to prolonged pain and invalidity.

The purpose of this study is to examine the value of these three techniques applied as a supplement to the existing technology and on this basis to prepare an algorithm for the examination of joint prosthesis infection.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Contamination of the operation area	We want to examine the existence of contamination before an operation in hip and knee. Furthermore, we want to examine the contamination to achieve better knowledge of the bacterial combination.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Description of the bacterial culture	We want to describe the bacterial culture to achieve better knowledge of the bacterial combination.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who have been through an alloplastic operation in hip og knee.

Exclusion Criteria:

Patients with cancer or a bilateral disease
Former patients who have been through an operation with implants in hip or knee.
Patients who might be infected in the joint due to operation in hip or knee.
Lack of informed consent or inability to read/understand Danish

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from Northern Orthopaedic Division, Clinic Frederikshavn.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eileen Kohler, PhD student	Orthopaedic Surgery Research Unit, Aalborg University Hospital	Principal Investigator
Sten Rasmussen, M.D.	Northern Orthopaedic Division, Aalborg University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Northern Orthopaedic Division, Clinic Frederikshavn		Frederikshavn	Northern Jutland		Denmark