IP-coated Revision Hip Implants

Официальное название

HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses

Обзор

The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic infection.

Подробное описание

The clinical investigation will include patients indicated for revision hip arthroplasty due to chronic periprosthetic infection. Subjects will either receive standard CE-marked revision hip implants or the newly developed IP (Infection prevention)- coated revision hip implants. The primary clinical benefit of the IP hip implant components remains the functional restoration of the hip joint and pain relief, as successfully shown for the uncoated predecessor devices, but additionally the IP coating is regarded ancillary to the intended purpose of the implant. Periprosthetic infections are one of the major complications in revision hip arthroplasty, leading to implant re-revision. A clinical investigation to evaluate additional measures to reduce this complication rate in revision total hip arthroplasty therefore has high clinical relevance.

Вмешательства

• Устройство IP Plasmafit® Revision cup (and stem) system
  Revision total hip arthroplasty (THA) due to periprosthetic joint infection

Первичные конечные точки

• Occurrence of periprosthetic joint infections [Срок оценки: 12 months]

Вторичные конечные точки (9)

• Change of functional outcome over follow-up period (Harris Hip Score (HHS)) [Срок оценки: 2 years post operative]
• Changes in quality of life [Срок оценки: 2 years post operative]
• Implant survival [Срок оценки: 2 years post operative]
• Radiographic assessment [Срок оценки: 2 years post operative]
• Occurrence of safety issues with the new device [Срок оценки: 2 years post operative]
• Level of silver ion concentration [Срок оценки: 12 months]
• Changes in blood biomarkers for liver function [Срок оценки: 12 months]
• Changes in blood biomarker for kidney function [Срок оценки: 12 months]
• Changes in blood biomarker for inflammation [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients > 18 years
• Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS definition): single-stage or two-stage surgical procedure according to clinical standard at the clinical investigation site
• According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits
• ASA physical status I - III
• Patient's signed written informed consent is available

Критерии исключения

• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
• The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect
• Patients who require plate osteosynthesis at the implantation site
• Patients with an already implanted silver-coated device
• Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
• Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy
• Severe soft tissue defects that require local or free flap procedure
• Periprosthetic joint infections with evidence of fungal infection
• Antibiotic suppression therapy
• BMI > 40 kg/m2
• Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions
• Known or patient reported hypersensitivity to silver or titanium
• Patients held in a custodial setting
• Patients in a relationship of dependence on the sponsor, the clinic or the investigator
• Patients with contraindication for the investigational and comparator devices:
• in case of secondary diseases influencing the function of the joint implant
• in case of severe osteoporosis or osteomalacia
• in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage
• in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union when use of prosthesis heads with neck length XXL is indicated

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Charité - Universitätsmedizin Berlin — Berlin

Польша · 1 центр

• Gruca Orthopedic and Trauma Teaching Hospital, Samodzielny Publiczny Szpital Kliniczny im. — Otwock

Публикации

• Alt V, Walter N, Baixauli F, Bialecki J, Dreyer L, Goronzy J, Hardt S, Herold D, Kendoff D, Maenz S, Rak D, Rudert M, Sionek A, Stiehler M, Meller S. HIPrevision - a multicenter prospective randomized control superiority trial of antimicrobial IP-coated revision hip prostheses versus non-IP-coated comparators for the revision of periprosthetic hip joint infections. Trials. 2026 Feb 17;27(1):174. d PMID 41699680

Идентификаторы

NCT: NCT06737809 · AAG-G-H-2023 · CIV-24-05-047447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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