Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 11108
Summary
- Conditions
- Osteoarthritis (Knee)
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients undergoing full-cemented primary TKA in any Norwegian hospitals are eligible for participation irrespectively of the diagnosis leading to TKA. and randomly assigned to receive ALBC (control group) or plain bone cement (experimental group).Masking: Double (Participant, Outcomes Assessor)Masking Description: This is a double blinded, non-inferiority register-based multicenter randomized controlled trial study. To ensure blinding of the patients, all patients are operated by the same surgical method and the type of cement is unknown to the patients. In this study, blinding of the surgeon is not possible because the surgeon recognizes the cement type and has to document the type of cement in the registration form. We believe the primary endpoint of this trial is not likely to be influenced by the surgeon knowledge of the cement used in the index surgery. The data analyst will be blinded for groups until the entire trial analysis has been completed to minimize the risk of bias that may be introduced during the statistical analysis because of the selective use and reporting of statistical tests.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04135170
- Collaborators
- Helse Vest
- Investigators
- Study Chair: Ove Furnes, MD/PhD The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital
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