Status:
UNKNOWN
Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
United Orthopedic Corporation
Conditions:
Knee; Infection, Joint
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A novel polyethylene-based knee spacer (United Cellbrick Knee Spacer), for the purpose of infection control, was developed to enhance biomechanical safety and surgical convenience of articulating knee...
Detailed Description
Two-stage exchange arthroplasty, which involves the removal of infected prostheses and introduction of a temporary antibiotic-loaded cement spacers at the infection site, has been widely accepted amon...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients who are 18 years of age or older, suitable for temporary knee joint implants, and will be undergoing treatment in Linkou Chang Gung Memorial Hospital who meet the following criteria and have skeletally mature bones:
- Patients who are diagnosed with infection before surgery and are expected to undergo two-stage procedure for total knee replacement (TKR);
- Patients who are willing to use traditional mobility aids (such as crutches, walkers) during implantation;
- The implantation time of the temporary knee implant shall not exceed 180 days.
- Exclusion Criteria
- Patients who are allergic to or have suffered from allergies to any component of the implant, the bone cement used together or antibiotics.
- Patients who cannot perform two-stage knee replacement surgery due to decreased immune response or other relevant clinical conditions.
- Patients who have not previously received total knee replacement surgery, and the secondary infection is caused by trauma, septic arthritis or other surgery.
- Sufficient support and / or fixation for implants due to disease, soft tissue defects, bone defects or other relevant clinical conditions.
- Inability or unwillingness to return to hospital for evaluation.
- Cognitive function impairment makes the subject unable to answer questions or cooperate with instructions.
- Other systemic comorbidities lead to severe impairment of the subject's mobility and function.
Exclusion
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06042062
Start Date
August 1 2023
End Date
July 31 2025
Last Update
April 17 2024
Active Locations (1)
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1
Department of Orthopedic Surgery at Linkou Changgung Memorial Hospital
Taoyuan District, Taiwan, 333