se of bone cement versus bone substitute material in two-stage replacement of septic hip endoprostheses
- Conditions
- Periprosthetic joint infection
- Registration Number
- DRKS00034162
- Lead Sponsor
- udwig-Maximilians-Universität München-Klinikum, Klinik für Orthopädie und Unfallchirurgie, Muskuloskelettales Universitätszentrum München (MUM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
1. Patients diagnosed with periprosthetic joint infection with hip arthroplasty in place, according to the EBJIS definition of periprosthetic joint infection
2. Male or female patients aged 18-75 years
3. Patients undergoing two-stage treatment for periprosthetic infection: Change of hip prosthesis is planned
4. Life expectancy of at least 1 year
5. The patient is willing to give informed consent and is able or sufficiently compliant to comply with the planned follow-up examinations, tests and medications.
1. Individuals who are unable to give informed consent to participate in the study or who are unwilling to give consent to participate in the study
2. Pregnant or breastfeeding women or women planning to do so during to become pregnant during the study period
3. Patients who are currently participating in a study of another drug or medical device or have previously been included in this study NOTE: Participation in another clinical study during the follow-up period is not permitted.
4. The presence of one of the contraindications listed in the current instructions for use of the test products CERAMENT G or CERAMENT V, or the instructions for use of Copal C/V
5. Patients with a confirmed multibacterial periprosthetic infection (= more than 1 phenotypically distinguishable pathogen) or a confirmed one Infection with fungi or vancomycin-resistant enterococci (VRE) or multidrug-resistant gram-negative bacteria (MRGN III and IV)
6. Patients who have undergone more than one previous operation on the affected hip joint
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Difference between groups in antibiotic concentrations in mg/L measured in drainage fluid during the first 3 days after surgery.<br>2. Difference in the histology of the samples taken from the prosthesis bed at the time of reimplantation in both groups, in each case compared to explanation (neutrophil granulocytes per main field of view (HPF, high-power field (400x magnification)[12]).<br>3. Difference in the microbiological culture results of the samples taken from the prosthesis storage at the time of reimplantation in both groups, in each case compared to explanation (all cultures negative, a single sample positive, more than two samples positive with the identical microorganism).
- Secondary Outcome Measures
Name Time Method 1. Clinical treatment success at 12 months, defined as: no recurrence of periprosthetic infection and no revision surgeries.<br>2. Radiographic Outcome at 12 Months - Treatment success defined as normal, expected bony integration of the prosthesis with no evidence of infection, no occurrence of osteolysis, prosthesis loosening, sequestration, or failure to progress in bone healing.