Actively Recruiting
Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Led by Zimmer Biomet · Updated on 2025-11-25
500
Participants Needed
16
Research Sites
272 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 nailing (standard or suprapatellar approach).
- Patient has one or more of the following: open fractures Gustilo Type I, II, III A or III B; delayed treatment with initial external fixation followed by intramedullary nail; fracture with ipsilateral leg compartment syndrome treated with fasciotomy; or closed fractures with severe tissue damage Tscherne grade C2 or C3.
- Patient will be treated with ZNN Bactiguard tibia for investigational group or was treated with uncoated titanium-alloy intramedullary tibia nail for control group.
You will not qualify if you...
- Patient is unwilling or unable to give consent.
- Patient is not expected to survive the follow-up schedule.
- Patient is anticipated to be non-compliant with the study protocol.
- Patient has a mental or neurological condition or alcohol/drug addiction preventing informed consent or follow-up participation.
- Patient is a prisoner.
- Patient is known to be pregnant and/or breastfeeding.
- Patient has a tibia fracture that is pathologic, Gustilo Type IIIC, multisegmented not eligible for intramedullary nailing, or wound closure more than 10 days after injury.
- Patient requires additional tibia fixation by plate (except screws or fibula plate fixation).
- Patient has head injury with Abbreviated Injury Score (AIS) ≥ 3.
- Control group patients lacking required minimum data.
- Tibia medullary canal obliterated by previous fracture or tumor.
- Tibia bone shaft with excessive bow or deformity.
- Insufficient bone substance or quality for stable nail seating.
- Concomitant diseases impairing operation or implant success.
- Insufficient blood circulation.
- Skeletally immature patients.
- Infection or contraindication to ZNN Bactiguard tibia.
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Tirolkliniken Innsbruck
Innsbruck, Austria, 6020
Actively Recruiting
2
Hôpital Ambroise-Paré
Boulogne-Billancourt, France, 92100
Actively Recruiting
3
Hôpitaux Universitaires de Marseille Nord
Marseille, France, 13915
Actively Recruiting
4
Universitätsklinikum Marburg
Marburg, Hesse, Germany, 35039
Actively Recruiting
5
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
6
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Actively Recruiting
7
AOU Policlinico di Bari
Bari, Italy, 70124
Actively Recruiting
8
Azienda Ospedaliero-Universitaria Careggi
Florence, Italy, 50134
Actively Recruiting
9
Tygerberg Hospital
Cape Town, South Africa, 7505
Actively Recruiting
10
Groote Schuur Hospital
Cape Town, South Africa, 7935
Actively Recruiting
11
Hospital Universitario Valle de Hebrón
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
12
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland, 8400
Actively Recruiting
13
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
14
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
15
The Royal London Hospital
London, United Kingdom, E1 1FR
Actively Recruiting
16
King's College Hospital NHS Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
G
Gemma de Ramon Francas
CONTACT
L
Lisa To
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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