Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Официальное название

Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control

Обзор

Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation. The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.

Подробное описание

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study with retrospective controls.

The study will enroll patients that will be implanted with the Zimmer Natural Nail Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails.

500 tibias will be recruited at maximum 15 sites and allocated on a 1:1 ratio into an:

* investigational group (prospective/consecutive series of 250 tibias treated with ZNN Bactiguard tibia) * a control group (retrospective series of 250 tibias treated with uncoated titanium-alloy tibia nail - data collection will be retrospective, these subjects will not have to undergo any study-related procedure).

The primary endpoint is the Fracture Related Infection (FRI) rate in the study population 12 months after fracture fixation.

The secondary endpoint is the confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation through the following measure systems:

* Radiologic (RUST) \& clinical (FIX-IT) fracture healing 12 months after fracture fixation (performance). * Patients' outcomes assessed by the Oxford Knee Score 12 months after fracture fixation (clinical benefits). * EQ5D-5L (patients' quality of life). * Incidence and frequency of adverse events (safety).

Data will be collected at 2 weeks, 3 months, 6 months and 1 year after fracture fixation.

Вмешательства

• Устройство ZNN Bactiguard tibia
  Tibia fracture fixation

Первичные конечные точки

• Fracture related infection (FRI) rate in investigational and control group [Срок оценки: 12 months after fracture fixation]

Вторичные конечные точки (5)

• Tibia fracture healing assessed radiologically through Radiographic Union Scale in Tibial fractures (RUST) score [Срок оценки: 12 months after fracture fixation]
• Tibia fracture healing assessed clinically through the Function IndeX for Trauma (FIX-IT) score [Срок оценки: 12 months after fracture fixation]
• Limb functionality measured through the Oxford Knee Score [Срок оценки: 12 months after fracture fixation]
• Quality of life of study participants assessed through the EQ-5D-5L questionnaire [Срок оценки: 12 months after fracture fixation]
• Incidence and frequency of adverse events [Срок оценки: 12 months after fracture fixation]

Критерии участия

Критерии включения

• Patient must be 18 or older.
• Patient has signed IRB/EC-approved informed consent (if applicable for retrospective controls, based on local requirements).
• Patient suffered primary tibia fracture (monolateral or bilateral) at high risk of infection, eligible for fixation by intramedullary (IM) nailing (standard or suprapatellar approach) and meets at least one of the following conditions:

• Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.
• Delayed treatment (initial treatment by external fixation due to swelling/ high energy trauma followed by definitive treatment by intramedullary nail).
• Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s).
• Closed fractures with severe tissue damage: Tscherne grade C2 and C3.
• Patient:

• will be treated with ZNN Bactiguard tibia for inclusion in investigational group (retrospective enrollment is allowed up to 1st follow-up visit);
• was treated with uncoated (conventional) titanium-alloy intramedullary tibia nail for inclusion in control group;

Критерии исключения

• Patient is unwilling or unable to give consent.
• Patient is not expected to survive follow-up schedule.
• Patient is anticipated to be non-compliant to the study protocol.
• Patient has a mental or neurological condition or alcohol/drug addiction that will not allow for proper informed consent and/or participation in follow-up program.
• Patient is a prisoner.
• Patient is known to be pregnant and/or breastfeeding.
• Patient suffered tibia fracture that meets any of the following conditions:

• Pathologic fracture.
• Gustilo Type IIIC open fracture.
• Patient has multisegmented fracture NOT eligible for fixation by intramedullary nailing.
• Patients with wound closure more than 10 days after injury.
• Besides IM nail, patient requires additional tibia fixation by plate (additional tibia fixation by screw(s) and/or fibula plate fixation are allowed).
• Concomitant with fracture, patient suffered head injury with Abbreviated Injury Score (AIS) ≥ 3.
• For control group:

• patient doesn't have all the minimum required data available:

• demographic information
• injury classification
• FRI information
• operative report and device information
• radiographic analyses (until fracture healing or confirmation of non-union leading to reoperation)
• Tibia medullary canal is obliterated by a previous fracture or tumor\*
• Tibia bone shaft having excessive bow or a deformity\*
• Lack of bone substance or bone quality, which makes stable seating of the nail implant impossible\*
• All concomitant diseases that can impair the operation, functioning or the success of the nail implant\*
• Insufficient blood circulation\*
• Skeletally immature patients\*
• Infection\*

• ZNN Bactiguard tibia contraindication

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Великобритания · 4 центра

• Royal Infirmary of Edinburgh — Edinburgh
• Leeds General Infirmary — Leeds
• The Royal London Hospital — London
• King's College Hospital NHS Trust — London

Германия · 3 центра

• Universitätsklinikum Marburg — Marburg
• Universitätsklinikum Leipzig — Leipzig
• Universitätsklinikum Regensburg — Regensburg

Франция · 2 центра

• Hôpital Ambroise-Paré — Boulogne-Billancourt
• Hôpitaux Universitaires de Marseille Nord — Marseille

Италия · 2 центра

• AOU Policlinico di Bari — Bari
• Azienda Ospedaliero-Universitaria Careggi — Florence

ЮАР · 2 центра

• Tygerberg Hospital — Cape Town
• Groote Schuur Hospital — Cape Town

Австрия · 1 центр

• Tirolkliniken Innsbruck — Innsbruck

Испания · 1 центр

• Hospital Universitario Valle de Hebrón — Barcelona

Швейцария · 1 центр

• Kantonsspital Winterthur — Winterthur

Идентификаторы

NCT: NCT05022485 · CMG2020-32T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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