Prospective multicenter observation of the bacterial spectrum during the course of a cement spacer treatment for hip implant-two stage exchange after septic implant loosening

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00004304

Enrollment

Registered

2012-08-24

Start date

2012-02-06

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T84.5

Interventions

Group 1: Patients are included with septic loosening of the primary hip implant and indications for hip-replacement and patients with a temporary femoral spacer implantat consist of an long -term est

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: • aged 50 to 80 years • diagnosis of septic loosening of hip prostheses with a primary indication for two-stage exchange • The ability to understand the scope and significance of the study and the willingness and the ability to take part in the following necessary follow-up examinations. • existence of a written consent form

Exclusion criteria

Exclusion criteria: • presence of a tumor disease • Known allergy to materials used • Participation in other studies • nursing and pregnant women and those women planning to become pregnant during the study period • non-availability for the duration of the study • Inadequate knowledge of German (questionnaires)

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the multicenter observation is the analysis of the microbial spectrum in the wound and the temporary cement spacer treatment for two stage exchange after septic implant loosening. Within the hip replacement standardized tissue samples are taken for the microbiology and pathology. The explanted prothesis is examined microbiologically. After a six-week interval a minimally-invasive sampling (biopsy) of peri-implant tissues is performed. The joint fluid and the tissue sample are examined microbiologically and the tissue sample is examined histologically. Within the spacer explantation standardized tissue samples are taken for the microbiology and pathology. The spacer is examined microbiologically.	—

Measure

Time frame

The primary endpoint of the multicenter observation is the analysis of the microbial spectrum in the wound and the temporary cement spacer treatment for two stage exchange after septic implant loosening. Within the hip replacement standardized tissue samples are taken for the microbiology and pathology. The explanted prothesis is examined microbiologically. After a six-week interval a minimally-invasive sampling (biopsy) of peri-implant tissues is performed. The joint fluid and the tissue sample are examined microbiologically and the tissue sample is examined histologically. Within the spacer explantation standardized tissue samples are taken for the microbiology and pathology. The spacer is examined microbiologically.

—

Secondary

Measure	Time frame
1.Time until the infection recurrence or treatment failure (calculated using Kaplan-Meier analysis, if needed, a multivariate Cox regression) at follow-up 2.Allocation of resources (material costs, hospitalization, number of necessary interventions) 3.Function (measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC score) and Harris Hip Score) and quality of life (using the EuroQol and SF-36 scores) at follow-up 4.Radiological signs of aseptic or septic loosening of the implant revision during follow-up	—

Measure

Time frame

1.Time until the infection recurrence or treatment failure (calculated using Kaplan-Meier analysis, if needed, a multivariate Cox regression) at follow-up 2.Allocation of resources (material costs, hospitalization, number of necessary interventions) 3.Function (measured using the Western Ontario and McMaster Osteoarthritis Index (WOMAC score) and Harris Hip Score) and quality of life (using the EuroQol and SF-36 scores) at follow-up 4.Radiological signs of aseptic or septic loosening of the implant revision during follow-up

—

Countries

Germany

Contacts

Public ContactSarah Zaatreh

Forschungslabor für Biomechanik und Implantattechnologie Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock

sarah.zaatreh@med.uni-rostock.de03814949374

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026