Spacer-K ATS in periprosthetic joint infection (PJI) of the knee
Research type
Research Study
Full title
Prospective observational study to evaluate safety and performance of Spacer-K ATS in the PJI of the knee joint.
IRAS ID
325793
Contact name
Edward Morrice Hyde Gardner
Contact email
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study aims to confirm the safety and performance of Spacer-K ATS in a post-market clinical follow-up (PMCF) study focusing on the treatment of periprosthetic joint infection (PJI) of the knee joint with a two-stage procedure.
Spacer-K ATS is a medical device that complements Spacer-K, a preformed knee spacer device used in case of PJI treated with a two-stage approach. The combination of ATS with Spacer-K addresses cases in which a severe tibial bone defect is present.
Enrolled patients will undergo pre-operative examinations for the treatment of PJI of the knee joint. The device will be applied during a procedure called two-stage revision which foresees the removal of an infected implant, surgical debridement and implantation of an antibiotic-loaded spacer.
The patient will receive targeted antibiotics over several weeks. When evidence of infection eradication will be achieved, the spacer will be removed, and a revision implant will be applied.
The study will not involve additional procedures to the hospital routine. Study-specific parameters will be collected before, during and after the spacer implantation. After removal of the spacer device, patients will be followed for an additional 2 years according to the routine follow-up visit schedule provided for this type of pathology to assess for any recurrence of infection.REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0377
Date of REC Opinion
16 Dec 2024
REC opinion
Further Information Favourable Opinion