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

NCT06042062 | Unknown

• 1 other identifier: 202300966A3
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee; Infection, Joint

Keywords

Infection Control; Two-Stage Exchange Arthroplasty; Knee Spacer

Outcome Measures

Primary Outcomes (1)

• 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 (%).

  up to 6 months following surgery

Secondary Outcomes (5)

• Vancomycin Concentration

  Day 1, 3, 7, up to 6 months following surgery

• Gentamycin Concentration

  Day 1, 3, 7, up to 6 months following surgery

• C-reactive protein assessment

  Baseline, 7, up to 6 months following surgery

• Bioassay of Antibiotic Activity of in Vitro Samples

  Day 1, 2, 3, 7

• Spacer Complications

  Baseline, Day 0, up to 6 months following surgery

Study Arms (2)

"Spacer" group

EXPERIMENTAL

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

Device: Spacer

"Novel spacer" group

EXPERIMENTAL

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

Device: Novel spacer

Interventions

Novel spacer 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).

"Novel spacer" group

Spacer 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).

"Spacer" group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• United Orthopedic Corporation: collaborator

Study Sites (1)

Department of Orthopedic Surgery at Linkou Changgung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Metered Dose Inhalers

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Yu-Han Chang, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Han Chang, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: September 18, 2023
• Study Start: August 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: April 17, 2024

Record last verified: 2023-08

Locations

TW (1)