Actively Recruiting
Post-Market Clinical Follow-up Study on the ZNN Bactiguard Retrograde Femoral Nails (Implants and Instrumentation)
Led by Zimmer Biomet · Updated on 2026-02-03
100
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail system in a post-market clinical follow-up study to confirm its safety, performance, and clinical benefits for patients with femoral fractures. This observational study focuses on how well the device helps with temporary internal fixation and stabilization of these fractures, with particular attention to fracture healing as the main outcome. Participants will receive the ZNN Bactiguard Retrograde Femoral Nail implanted to fix and stabilize their femoral fracture. The study tracks their recovery over time without testing other treatments or placebos. The device is used during surgery, and the study observes how it performs in real-world medical use. During the study, participants will be monitored at 3, 6, and 12 months after surgery. Researchers will assess fracture healing rates, limb function using the Oxford Knee Score, and quality of life with the EQ-5D-5L questionnaire. They will also record any complications or adverse events, including infections related to the fracture. The total participation duration is up to 12 months, with careful follow-up to gather patient-reported outcomes and safety data.
CONDITIONS
Brief 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.
- Have a femoral fracture (open, closed, monolateral, or bilateral) requiring surgical fixation by intramedullary nailing.
- Patients with delayed treatment by external fixation followed by intramedullary nailing are eligible.
- Have been or are scheduled to be treated with the ZNN Bactiguard Retrograde Femoral Nail.
- Able and willing to complete the required follow-up.
- Have signed an ethics committee approved consent.
- Capable of understanding surgeon's explanations and following instructions.
You will not qualify if you...
- Skeletally immature patients.
- Medullary canal blocked by previous fracture or tumor.
- Bone shaft with excessive bowing or deformity.
- Lack of bone substance or quality preventing stable implant seating.
- Concomitant diseases impairing operation or implant success.
- Insufficient blood circulation.
- Infection at the fracture site.
- Unwilling or unable to give consent.
- Vulnerable subjects (prisoners, mentally incompetent, alcohol/drug addiction, pregnant or breastfeeding).
- Anticipated non-compliance or difficulty maintaining follow-up.
- Not expected to survive the follow-up period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive the ZNN Bactiguard Retrograde Femoral Nail for the temporary internal fixation and stabilization of femoral fractures.
1 visit (in-person)
Duration - 12 months after fracture fixation
Participants are monitored to assess fracture healing, safety, clinical benefit, and incidence of fracture-related infections following implantation.
Visits at 3, 6, and 12 months after fracture fixation
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
E
Emilie Rohmer
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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