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

Recruiting now

Conditions studied: Tibial Fractures, Fracture Infection

In brief

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.

Key facts

Study ID

NCT05022485

Run by

Zimmer Biomet

People needed

500

Starts

2022-04-11

Expected to finish

2027-07-01

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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*

Where it is running

• Tirolkliniken Innsbruck — Innsbruck, Austria (enrolling)
• Hôpital Ambroise-Paré — Boulogne-Billancourt, France (enrolling)
• Hôpitaux Universitaires de Marseille Nord — Marseille, France (enrolling)
• Universitätsklinikum Marburg — Marburg, Hesse, Germany (enrolling)
• Universitätsklinikum Leipzig — Leipzig, Germany (enrolling)
• Universitätsklinikum Regensburg — Regensburg, Germany (enrolling)
• AOU Policlinico di Bari — Bari, Italy (enrolling)
• Azienda Ospedaliero-Universitaria Careggi — Florence, Italy (enrolling)
• Tygerberg Hospital — Cape Town, South Africa (enrolling)
• Groote Schuur Hospital — Cape Town, South Africa (enrolling)
• Hospital Universitario Valle de Hebrón — Barcelona, Catalonia, Spain (enrolling)
• Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland (enrolling)
• Royal Infirmary of Edinburgh — Edinburgh, United Kingdom (enrolling)
• Leeds General Infirmary — Leeds, United Kingdom (enrolling)
• The Royal London Hospital — London, United Kingdom (enrolling)
• King's College Hospital NHS Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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