Actively Recruiting
ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Led by Zimmer Biomet · Updated on 2026-02-03
100
Participants Needed
4
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Post-market clinical follow-up (PMCF) study to confirm the safety, performance, and clinical benefits of the intra-medullary retrograde femoral nail Zimmer Natural Nail (ZNN) Bactiguard (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
CONDITIONS
Official Title
ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older.
- Patients must have a femoral fracture (open, closed, one or both sides) needing surgical fixation with intramedullary nailing.
- Patients treated or scheduled to be treated with the ZNN Bactiguard Retrograde Femoral Nail.
- Patients able and willing to complete all follow-up visits.
- Patients must have signed an ethics committee approved consent.
- Patients capable of understanding surgeon's explanations and following instructions.
You will not qualify if you...
- Patients who are still growing (skeletally immature).
- Patients with a blocked medullary canal due to prior fracture or tumor.
- Patients with excessive bone shaft bowing or deformity.
- Patients lacking sufficient bone quality or substance to securely seat the implant.
- Patients with diseases that could impair surgery, implant success, or function.
- Patients with poor blood circulation.
- Patients with active infection.
- Patients unwilling or unable to give consent.
- Vulnerable patients such as prisoners, mentally incompetent, pregnant or breastfeeding women, or those with addiction.
- Patients unlikely to follow the study program (e.g., no fixed address, planning to move).
- Patients not expected to survive the follow-up period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Hospital Universitario Ntra. Sra. de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Active, Not Recruiting
2
Leeds General Infirmary
Leeds, LEEDS, United Kingdom, LS1 3EX
Actively Recruiting
3
Manchester Royal Infirmary
Manchester, United Kingdom
Actively Recruiting
4
Stepping Hill Hospital
Stockport, United Kingdom
Active, Not Recruiting
Research Team
G
Gemma de Ramon Francàs
CONTACT
E
Emilie Rohmer
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
1
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