Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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.
Eligibility criteria
Qualifiers
Patient must be 18 or older.
Patient has signed IRB/EC-approved informed consent (if applicable for retrospective controls, based on local requirements).
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ZNN Bactiguard tibia
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov