Evaluation of a new knee spacer for infection control in joint surgery

Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer

This study is testing a new knee spacer to see if it can better prevent infections during knee joint surgeries compared to the usual spacers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Locations: 1 site (Taoyuan)
• Trial ID: NCT06042062 on ClinicalTrials.gov

What this trial studies

This clinical evaluation focuses on the United Cellbrick Knee Spacer, a novel polyethylene-based device designed to improve infection control during two-stage exchange arthroplasty for knee joint infections. The study compares the performance and safety of this new spacer against traditional articulating spacers in a practical clinical setting. By assessing a total of 10 participants undergoing the procedure at Linkou Changgung Memorial Hospital, the research aims to enhance understanding of the spacer's biomechanical safety and surgical convenience. The study will also evaluate the effectiveness of the spacer in maintaining joint space and facilitating antibiotic release.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are diagnosed with knee joint infections and are scheduled for two-stage knee replacement surgery.

Not a fit: Patients who are allergic to any components of the implant or who cannot undergo the two-stage procedure due to immune response issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing knee joint infection treatments by providing a safer and more effective spacer option.

How similar studies have performed: While articulating spacers have shown success in infection control, the United Cellbrick Knee Spacer represents a novel approach that has not been extensively tested in prior studies.

Eligibility criteria

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:

1. Patients who are diagnosed with infection before surgery and are expected to undergo two-stage procedure for total knee replacement (TKR);
2. Patients who are willing to use traditional mobility aids (such as crutches, walkers) during implantation;
3. The implantation time of the temporary knee implant shall not exceed 180 days.

Exclusion Criteria

1. Patients who are allergic to or have suffered from allergies to any component of the implant, the bone cement used together or antibiotics.
2. Patients who cannot perform two-stage knee replacement surgery due to decreased immune response or other relevant clinical conditions.
3. Patients who have not previously received total knee replacement surgery, and the secondary infection is caused by trauma, septic arthritis or other surgery.
4. Sufficient support and / or fixation for implants due to disease, soft tissue defects, bone defects or other relevant clinical conditions.
5. Inability or unwillingness to return to hospital for evaluation.
6. Cognitive function impairment makes the subject unable to answer questions or cooperate with instructions.
7. Other systemic comorbidities lead to severe impairment of the subject's mobility and function.

Where this trial is running

Taoyuan

• Department of Orthopedic Surgery at Linkou Changgung Memorial Hospital — Taoyuan, Taiwan (Recruiting)

Study contacts

• Principal investigator: Yu-Han Chang, MD, PhD — Chang Gung Memorial Hospital
• Study coordinator: Yu-Han Chang, MD, PhD

Conditions Knee; Infection, Joint; Infection Control; Two-Stage Exchange Arthroplasty; Knee Spacer