Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer
Study Details
Study Description
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 spacers. In the present study, Commercially available cemented spacer were compared to the novel United Cellbrick Knee Spacer in a practical setting to enhance our understanding of the safety and performance of United Cellbrick Knee Spacer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 among treatment options. Antibiotic-loaded cement spacers facilitate in maintaining joint space, limb length, soft tissue tension, and lengthening the period of effective antibiotic release until infection control has been accomplished. Although articulating knee spacers have demonstrated advantages in joint mobility and clinically successful rates in infection control, issues relating to biomechanical safety contributed by cement material characteristics have been noted. Surgeons had to implement alternative methods for the construction of an intramedullary spacer to provide sufficient infection control for deeper infection sites which could cause surgical inconveniences. A novel polyethylene-based knee spacer, for the purpose of infection control, was developed to enhance biomechanical safety and surgical convenience of articulating knee spacers. The investigators aim to conduct a clinical study comparing the use of commercially available cemented spacer to the United Cellbrick Knee Spacer in a practical setting to better understand the safety and performance of United Cellbrick Knee Spacer and to enhance the clinical confidence of surgeons. A total of 10 patients who are undergoing two-stage exchange arthroplasty at Linkou Changgung Memorial Hospital will be recruited, including 5 patients in the "spacer" group and 5 patients in the "novel spacer" group. Patients in the "spacer" group will be receiving a full cement spacer (Stryker Simplex P) made of broad-acting antibiotics (Vancomycin + Gentamicin) produced in the hospital. Patients in the "novel spacer" group will be receiving United Cellbrick Knee Spacer, where the femoral and tibial spacers will be filled with bone cement (Stryker Simplex P) with antibiotics (Vancomycin + Gentamicin). Spacer survivorship defined as no removal or revision of any components as a result of mechanical failure or complications will be analyzed. Blood tests, joint effusions, and x-ray inspections will also be collected for analysis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| "Spacer" group The subjects who are assigned to Commercially available cement spacers in two-stage exchange arthroplasty. |
Device: Two-stage exchange arthroplasty
The indication for two-stage exchange arthroplasty is mainly periprosthetic joint infection.
Other Names:
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| "Novel spacer" group The subjects who are assigned to United Cellbrick Knee Spacer in two-stage exchange arthroplasty. |
Device: Two-stage exchange arthroplasty
The indication for two-stage exchange arthroplasty is mainly periprosthetic joint infection.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Success Rate [up to 6 months following surgery]
Failure is defined as removal or revision of any components as a result of mechanical failure or complications. Success is defined as implants that are successfully implanted without any failure for the duration of up to 180 days. *Note: Spacers are temporarily implanted into patients for any two-stage arthroplasty. Hence, upon assessment by the surgeon, when the condition of the patients are ideal for the second-stage arthroplasty procedure, the surgeon will remove the spacer accordingly. Therefore, the timeframe for the spacer removal may happen anywhere before the duration of 180 days. The success rate will be represented as a percentage (%).
Secondary Outcome Measures
- Vancomycin Concentration [Day 1, 3, 7, up to 6 months following surgery]
Vancomycin Concentration will be quantified utilizing Particle Enhanced Turbidimetric Inhibition Immunoassay. Blood samples (3mL) and joint effusion samples (5-10cc) will both be used to analyze the efficacy of vancomycin concentration (5-15ug/mL).
- Gentamycin Concentration [Day 1, 3, 7, up to 6 months following surgery]
Gentamycin Concentration will be quantified utilizing Particle Enhanced Turbidimetric Inhibition Immunoassay. Blood samples (3mL) and joint effusion samples (5-10cc) will both be used to analyze the efficacy of gentamycin concentration (5-15ug/mL).
- C-reactive protein assessment [Baseline, 7, up to 6 months following surgery]
C-reactive protein assessment will be quantified utilizing turbidimetric-immunoassay. Blood samples (3mL) will be used to determine the level of inflammation.
- Bioassay of Antibiotic Activity of in Vitro Samples [Day 1, 2, 3, 7]
Bioassay of Antibiotic Activity of in Vitro Samples will be quantified utilizing aliquots of the samples and a modified microtube dilution bioassay. The following strains were selected as test organisms: Methicillin-susceptible Staphylococcus aureus (MSSA, ATCC 25923), Methicillin-resistant Staphylococcus aureus (MRSA, ATCC 43300), Staphylococcus epidermidis (ATCC 14990), Pseudomonas aeruginosa (P. aeruginosa, ATCC 27853) or Escherichia coli (E. coli, ATCC 25922). The in vitro samples were were inoculated with 105 colony forming units (CFUs) of bacteria per milliliter in 96-well culture dishes and incubated at 37 degree Celsius for 24 hours according to Hsu et al. The growth of bacteria associated with the different concentrations of antibiotics was compared visibly with each other and against the positive control (without antibiotic). The minimum inhibitory concentration of each antibiotic against each bacterium was determined by microtube dilution bioassay.
- Spacer Complications [Baseline, Day 0, up to 6 months following surgery]
Any issues with spacer complications including allergic reactions, bone loss, joint stiffness, wound complications, recurrence or persistence of the infection, spacer fracture or dislocation, and side effects of local or systemic antibiotics will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients who are older than 18 years old, 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:
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who are diagnosed with infection before surgery and are expected to undergo two-stage procedure for total knee replacement (TKR);
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Patients who are willing to use traditional mobility aids (such as crutches, walkers) during implantation;
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The implantation time of the temporary knee implant shall not exceed 180 days.
Exclusion Criteria:
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Patients who are allergic to or have suffered from allergies to any component of the implant, the bone cement used together or antibiotics.
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Patients who cannot perform two-stage knee replacement surgery due to decreased immune response or other relevant clinical conditions.
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Patients who have not previously received total knee replacement surgery, and the secondary infection is caused by trauma, septic arthritis or other surgery.
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sufficient support and / or fixation for implants due to disease, soft tissue defects, bone defects or other relevant clinical conditions.
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Inability or unwillingness to return to hospital for evaluation.
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Cognitive function impairment makes the subject unable to answer questions or cooperate with instructions.
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Other systemic comorbidities lead to severe impairment of the subject's mobility and function.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Orthopedic Surgery at Linkou Changgung Memorial Hospital | Taoyuan | Taiwan | 333 |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
- United Orthopedic Corporation
Investigators
- Principal Investigator: Yu-Han Chang, MD, PhD, Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202300966A3