ZNN bactiguard Tibia study
Research type
Research Study
Full title
Performance, safety and clinical benefits of a noble metal alloy-coated intramedullary nail: a multicenter, prospective trial with a retrospective control
IRAS ID
301711
Contact name
Peter Giannoudis
Contact email
Sponsor organisation
Zimmer GmbH
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
This project consists in an international, multi-center, observational post-market clinical follow-up study involving patients implanted with the Zimmer Natural Nail (ZNN) Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails.
The study will enroll patients who suffered from tibia fractures that are considered at high risk of infection (as defined in the inclusion criteria).
The primary objective is to compare fracture related infection (FRI) rates in subjects who received the ZNN Bactiguard nail compared to those implanted with conventional titanium-alloy nails (no coating or antibiotics). The comparison will be carried out 12 months after fracture fixation.
The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant.The Bactiguard device is a tibia intramedullary nail that is covered by a special coating. The Bactiguard coating has been developed to reduce adhesion of microbes to the nail and therefore reduce implant-related infections. All implant components are CE-marked and commercially available.
500 cases will be overall enrolled and allocated on a 1:1 ratio into:
• an investigational group: prospective/consecutive series of 250 tibias treated with the ZNN Bactiguard tibia; after fixation surgery, the subjects will be followed up at 2 weeks, 3 months, 6 months and 1 year (X-rays of the tibia will be taken, healing process of the fracture will be evaluated, as well as benefits/well-being of the subjects);
• a control group: retrospective/consecutive series of 250 tibias treated with standard titanium-alloy tibia nail. These subjects will not have to undergo any study-related procedure, since data collection will be retrospective.
Up to a maximum of 15 global sites (major trauma centers) will be included in the study.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0167
Date of REC Opinion
4 Aug 2022
REC opinion
Further Information Favourable Opinion