Набор по приглашению NCT05640336

Treatment of Acute Periprosthetic Joint Infection Comparing Single and Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression

Без фазы С лечением Periprosthetic Joint Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Single Debridement, Antibiotics and Implant Retention, Planned Double Debridement, Antibiotics and Implant Retention.
Кому может быть актуально: Состояния в реестре: Periprosthetic Joint Infection. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Single vs Planned Double-Debridement Antibiotics and Implant Retention Followed by Chronic Antibiotic Suppression for the Treatment of Acute Periprosthetic Joint Infection: A Prospective, Multicenter, Randomized Clinical Trial

Обзор

The purpose of this research is to evaluate two different standard of care surgeries in treating periprosthetic joint infection (PJI) after total hip and knee arthroplasty. Researchers are looking at differences in outcomes following single versus planned double debridement, antibiotics, and implant retention (DAIR) for acutely infected total hip arthroplasty (THA), and total knee arthroplasties (TKAs).

Вмешательства

Процедура Single Debridement, Antibiotics and Implant Retention
Surgical debridement and wash out of infected joint. The polyethylene (plastic) insert, which acts as the articulating surface (modular component) of the prosthesis, will be removed and the exposed surfaces scrubbed, sterilized, and soaked. A new modular component will be placed with additional irrigation and antiseptic soak. Tissue cultures will be sent to the lab for further evaluation and antibiotic guidance. After the operation subjects will continue six weeks of IV antibiotics followed by o
Процедура Planned Double Debridement, Antibiotics and Implant Retention
Surgical debridement and wash out of infected joint with an additional irrigation and debridement scheduled for approximately 5 days after the initial DAIR. During the first washout, antibiotic cement beads will be placed in the joint and these will remain in the interim until they are removed during the second washout. During the second DAIR, the antibiotic beads are removed, and the modular components are once again removed and replaced with new components. Exposed surfaces are again irrigated

Первичные конечные точки

Subjects free from failure [Срок оценки: 1 year following DAIR.]

Вторичные конечные точки (9)

Readmission within 90 days of the surgical DAIR procedure [Срок оценки: 90 days following DAIR procedure]
1-year surgical reoperation rate [Срок оценки: 1 year following DAIR procedure]
5-year surgical reoperation rate [Срок оценки: 5 years following DAIR procedure]
10-year surgical revision rate [Срок оценки: 10 years following DAIR procedure]
Hospital length of stay [Срок оценки: Approximately 2 weeks following DAIR procedure]
Resource analysis [Срок оценки: Approximately 2 weeks following DAIR procedure]
Clinical Outcome Scores [Срок оценки: 1, 5, and 10 years following DAIR procedure]
Adverse events [Срок оценки: 10 years following DAIR procedure]
Survivorship [Срок оценки: 10 years following DAIR procedure]

Критерии участия

Критерии включения

Patients who speak English and are willing to sign the consent form
Patients with acute early postoperative infection (symptoms ≤ 4 weeks from surgery; symptoms < 4 weeks in duration) and acute hematogenous infection (greater than 4 weeks from surgery; symptoms < 3 weeks in duration) of a primary total knee or total hip arthroplasty, defined as:

A sinus communicating with the prosthesis OR
Two positive cultures obtained from the prosthesis OR
4 of 5 criteria: Elevated ESR (> 30mm/hr) and CRP (> 10mg/L); Elevated synovial leukocyte count (>3000 cells/μL) or change of ++ on; leukocyte esterase strip; Elevated synovial neutrophil percentage (> 80%); One positive culture; Positive histological analysis of periprosthetic tissue (> 5 neutrophils per high; Power field in 5 high power fields x 400).
OR Patient with an acute infection diagnosed clinically by an orthopedic surgeon treated with DAIR