Prosthetic InfectionsNCT01493375
Surgical Field Bacterial Contamination in Primary Total Hip (THA) and Knee (TKA) Arthroplasty
An observational study of Prosthetic Infections, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic Infections
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Northern Orthopaedic Division, Clinic Frederikshavn.
Who may be able to join
- Patients who have been through an alloplastic operation in hip og knee.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Northern Orthopaedic Division, Clinic Frederikshavn
Frederikshavn, Northern Jutland
About this study
Official title: Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery
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.
- Conditions
- Prosthetic Infections
- Keywords
- Contamination, hip operation, knee operation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Description of the bacterial culture
We want to describe the bacterial culture to achieve better knowledge of the bacterial combination.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2011 (estimated)
- Study startJun 2010
- Primary completionDec 2010
Why it stopped: Study principal investigator left the organization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Orthopaedic Division, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, Aalborg University
- Responsible party
- Sponsor
- Investigators
- Eileen Kohler, PhD student, Principal investigator, Orthopaedic Surgery Research Unit, Aalborg University HospitalSten Rasmussen, M.D., Study director, Northern Orthopaedic Division, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493375
- Sponsor's protocol ID
- N-20100008
- Status last verified
- May 2015
- First submitted
- 14 Dec 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT01493375
- Acronym / sponsor ID
- N-20100008
- Conditions
- Prosthetic Infections
- Keywords
- Contamination, hip operation, knee operation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study principal investigator left the organization
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northern Orthopaedic Division, DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aarhus, Aalborg University
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- First posted
- 16 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Northern Orthopaedic Division, Clinic Frederikshavn.
Key inclusion criteria (1 listed)
- Patients who have been through an alloplastic operation in hip og knee.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Contamination of the operation area
Time frame: 12 months
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.
1 secondary outcome
Description of the bacterial culture
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Kohler, PhD student principal investigator
Orthopaedic Surgery Research Unit, Aalborg University Hospital
Sten Rasmussen, M.D. study director
Northern Orthopaedic Division, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthetic Infections, run by Northern Orthopaedic Division, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contamination of the operation area (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.