Prosthetic Infections Clinical Trial
Official title:
Surgical Field Bacterial Contamination in Primary Hip and Knee Replacement Surgery
| NCT number | NCT01493375 |
| Other study ID # | N-20100008 |
| Secondary ID | |
| Status | Suspended |
| Phase | N/A |
| First received | December 14, 2011 |
| Last updated | May 27, 2015 |
| Start date | June 2010 |
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.
| Status | Suspended |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Northern Orthopaedic Division, Clinic Frederikshavn | Frederikshavn | Northern Jutland |
| Lead Sponsor | Collaborator |
|---|---|
| Northern Orthopaedic Division, Denmark | Aalborg University, Aarhus University Hospital, University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Description of the bacterial culture | We want to describe the bacterial culture to achieve better knowledge of the bacterial combination. | 12 months | No |