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

NCT ID: NCT06042062

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-07-31

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, 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.

Conditions

Knee; Infection, Joint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Spacer" group

The subjects who are assigned to Articulating Spacers in two-stage exchange arthroplasty.

Group Type: EXPERIMENTAL

Spacer

Intervention Type: DEVICE

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).

"Novel spacer" group

The subjects who are assigned to United Cellbrick Knee Spacer in two-stage exchange arthroplasty.

Group Type: EXPERIMENTAL

Novel spacer

Intervention Type: DEVICE

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).

Interventions

Novel spacer

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).

Intervention Type: DEVICE

Spacer

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).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United Orthopedic Corporation

INDUSTRY

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Han Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Department of Orthopedic Surgery at Linkou Changgung Memorial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Han Chang, MD, PhD

Role: CONTACT

yhchang@adm.cgmh.org.tw

886-3-3281200 ext. 2420

Facility Contacts

Yu-Han Chang, MD, PhD

Role: primary

yhchang@adm.cgmh.org.tw

886-3-3281200 ext. 2420

Other Identifiers

202300966A3

Identifier Type: -

Identifier Source: org_study_id