Prospective randomized multicenter clinical observationan of a novel cement spacer implants for for knee implant-two stage exchange after septic implant loosening
- Conditions
- T84.5Infection and inflammatory reaction due to internal joint prosthesis
- Registration Number
- DRKS00004357
- Lead Sponsor
- Forschungslabor für Biomechanik und Implantattechnologie Orthopädische Klinik und Poliklinik, Universitätsmedizin Rostock
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
• aged 50 to 80 years
• diagnosis of septic loosening of knee 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
• 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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method