Knee; Infection, JointNCT06042062
Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer
A study testing Novel spacer and Spacer in people with Knee; Infection, Joint, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee; Infection, Joint
- What is being tested?
- Novel spacer and Spacer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Orthopedic Surgery at Linkou Changgung Memorial Hospital
Taoyuan, 333
Yu-Han Chang, MD, PhD, 886-3-3281200 ext. 2420, yhchang@adm.cgmh.org.tw
Yu-Han Chang, MD, PhD
About this study
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.
Read the 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 Articulating Spacers to United Cellbrick Knee Spacers in a practical setting to better understand the safety and performance of United Cellbrick Knee Spacers and to enhance the clinical confidence of investigators. A total of 10 participants who are undergoing two-stage exchange arthroplasty at Linkou Changgung Memorial Hospital will be recruited, including 5 participants in the "Spacer" group and 5 participants in the "Novel Spacer" group.
Participants in the "Spacer" group will receive a full-cement spacer (Stryker, Simplex P) made of broad-acting antibiotics (Vancomycin and Gentamicin) produced in the hospital.
Participants in the "Novel Spacer" group will receive a United Cellbrick Knee Spacer, where the femoral and tibial spacers will be filled with bone cement (Stryker Simplex P) with antibiotics (Vancomycin and 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.
- Conditions
- Knee; Infection, Joint
- Being tested
- Novel spacer, Spacer
- Keywords
- Infection Control, Two-Stage Exchange Arthroplasty, Knee Spacer
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel spacerDevice
After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either a United Cellbrick spacer (United Orthopedic Corporation, Taiwan) or an articulating full-cement spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either a Cellbrick spacer or an articulating spacer will be placed. As for the United Cellbrick spacer, antibiotic loaded bone cement (ALBC) will be molded into the designed holes (fenestrations). The ALBC will be formed from an antibiotic mixture of Vancomycin and Gentamicin with bone cement (Stryker, Simplex P).
SpacerDevice
After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either a Cellbrick spacer (United Orthopedic Corporation, Taiwan) or an articulating full-cement spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either an United Cellbrick spacer or an Articulating Spacer will be placed. The Articulating Spacer will be hand-made to fit the femoral and tibial exposed metaphyses as a solid block with associated antibiotic loaded bone cement (ALBC). The ALBC will be formed from an antibiotic mixture of Vancomycin and Gentamicin with bone cement (Stryker, Simplex P).
| Study group | Role | What they receive |
|---|---|---|
| "Spacer" group | Experimental | The subjects who are assigned to Articulating Spacers in two-stage exchange arthroplasty. Receives: Device: Spacer |
| "Novel spacer" group | Experimental | The subjects who are assigned to United Cellbrick Knee Spacer in two-stage exchange arthroplasty. Receives: Device: Novel spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
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 (%).
Measured: up to 6 months following surgery
Secondary outcomes (5)
Vancomycin Concentration
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).
Measured: Day 1, 3, 7, up to 6 months following surgery
Gentamycin Concentration
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).
Measured: Day 1, 3, 7, up to 6 months following surgery
C-reactive protein assessment
C-reactive protein assessment will be quantified utilizing turbidimetric-immunoassay. Blood samples (3mL) will be used to determine the level of inflammation.
Measured: Baseline, 7, up to 6 months following surgery
Bioassay of Antibiotic Activity of in Vitro Samples
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.
Measured: Day 1, 2, 3, 7
Spacer Complications
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.
Measured: Baseline, Day 0, up to 6 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Aug 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee; Infection, JointStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United Orthopedic Corporation
- Responsible party
- Sponsor
- Investigators
- Yu-Han Chang, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042062
- Sponsor's protocol ID
- 202300966A3
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Infection Control to Knee Periprosthetic Joint Infection (PJI) -United Cellbrick Knee Spacer
- ClinicalTrials.gov ID
- NCT06042062
- Acronym / sponsor ID
- 202300966A3
- Conditions
- Knee; Infection, Joint
- Keywords
- Infection Control, Two-Stage Exchange Arthroplasty, Knee Spacer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- United Orthopedic Corporation
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Articulating Spacers to United Cellbrick Knee Spacers in a practical setting to better understand the safety and performance of United Cellbrick Knee Spacers and to enhance the clinical confidence of investigators. A total of 10 participants who are undergoing two-stage exchange arthroplasty at Linkou Changgung Memorial Hospital will be recruited, including 5 participants in the "Spacer" group and 5 participants in the "Novel Spacer" group.
Participants in the "Spacer" group will receive a full-cement spacer (Stryker, Simplex P) made of broad-acting antibiotics (Vancomycin and Gentamicin) produced in the hospital.
Participants in the "Novel Spacer" group will receive a United Cellbrick Knee Spacer, where the femoral and tibial spacers will be filled with bone cement (Stryker Simplex P) with antibiotics (Vancomycin and 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Spacer" group | Experimental | Device: SpacerThe subjects who are assigned to Articulating Spacers in two-stage exchange arthroplasty. |
| "Novel spacer" group | Experimental | Device: Novel spacerThe subjects who are assigned to United Cellbrick Knee Spacer in two-stage exchange arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel spacerAfter diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either a United Cellbrick spacer (United Orthopedic Corporation, Taiwan) or an articulating full-cement spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either a Cellbrick spacer or an articulating spacer will be placed. As for the United Cellbrick spacer, antibiotic loaded bone cement (ALBC) will be molded into the designed holes (fenestrations). The ALBC will be formed from an antibiotic mixture of Vancomycin and Gentamicin with bone cement (Stryker, Simplex P). | Device | "Novel spacer" group |
| SpacerAfter diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either a Cellbrick spacer (United Orthopedic Corporation, Taiwan) or an articulating full-cement spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either an United Cellbrick spacer or an Articulating Spacer will be placed. The Articulating Spacer will be hand-made to fit the femoral and tibial exposed metaphyses as a solid block with associated antibiotic loaded bone cement (ALBC). The ALBC will be formed from an antibiotic mixture of Vancomycin and Gentamicin with bone cement (Stryker, Simplex P). | Device | "Spacer" group |
Primary outcome
Success Rate
Time frame: 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 (%).
5 secondary outcomes
Vancomycin Concentration
Time frame: Day 1, 3, 7, up to 6 months following surgery
Gentamycin Concentration
Time frame: Day 1, 3, 7, up to 6 months following surgery
C-reactive protein assessment
Time frame: Baseline, 7, up to 6 months following surgery
Bioassay of Antibiotic Activity of in Vitro Samples
Time frame: Day 1, 2, 3, 7
Spacer Complications
Time frame: Baseline, Day 0, up to 6 months following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Han Chang, MD, PhD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel spacer and Spacer in people with Knee; Infection, Joint, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Han Chang, MD, PhD (886-3-3281200 ext. 2420, yhchang@adm.cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: up to 6 months following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.