UnknownNot Applicable

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

Taiwan10 participantsStarted 2023-08-01

Plain-language 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 spacers. In the present study, Articulating Spacers were compared to the United Cellbrick Knee Spacers in a practical setting to enhance our understanding of the safety and performance of United Cellbrick Knee Spacer.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

What they're measuring

Success Rate

Timeframe: up to 6 months following surgery

Trial details

NCT IDNCT06042062

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

Contact for this trial

Yu-Han Chang, MD, PhD

886-3-3281200 yhchang@adm.cgmh.org.tw

View on ClinicalTrials.gov More Knee; Infection, Joint trials