An observational study in Osteotomy, Trochanteric Fractures and Sub-trochanteric Fractures, sponsored by Zimmer Biomet. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Zimmer Biomet · Observational
This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Cephalomedullary Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of trochanteric, sub-trochanteric or shaft femoral fractures and osteotomies.
This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.
This study is a multicentre, prospective, post-market clinical follow-up study on the Zimmer Natural Nail (ZNN) Bactiguard Cephalomedullary Nails. The primary endpoint for this study is the assessment of performance by analyzing fracture/osteotomy healing within 12 months after fracture fixation. Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP and lateral radiographs and clinically as full weight-bearing without pain.
The secondary endpoint is the assessment of safety, clinical benefit, and postop fracture-related infection (FRI). Safety will be evaluated by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Clinical benefit will be assessed by recording patient-reported outcome measures (PROMs). FRIs will be classified according to the updated diagnostic algorithm defined by the FRI Consensus Group. Data will be collected at 6 weeks, 3 months, 6 months and 1 year after fracture fixation. The study will enroll patients implanted with the Zimmer Natural Nail Bactiguard Cephalomedullary Nail according to the approved/cleared indications. The sample size for this study is 150 study cases, and up to 10 sites in EMEA will participate.
822 studies on the registry are indexed under Hip Fractures; 160 are open to participants now.
This study's enrollment of 149 is close to the median of 140 across 268 observational studies indexed under Hip Fractures.
Browse Hip Fractures studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Consecutive series of patients aged 18 or older with femur fractures or osteotomies implanted with the ZNN Cephalomedullary Nail according to the approved/cleared indications.
Exclusion Criteria:
Subjects that have received or will receive the ZNN Bacitugard Cephalomedullaryl Nail to treat trochanteric, sub-trochanteric, and shaft fractures and osteotomies according to the cleared/approved indications.
Procedure: Fracture fixation via Intramedullary Nailing
Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.
Performance of the study device by analyzing fracture/osteotomy healing at 12 months after fracture fixation.
Performance will be assessed by analyzing fracture/osteotomy healing at 12 months after fracture fixation. Fracture healing will be assessed clinically and radiologically: * Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP. and lateral radiographs * Clinical fracture healing is defined as full weight-bearing without pain.
Time frame: 12 months after fracture fixation
Safety assessment by recording and analyzing incidence and frequency of adverse events.
Recording and analyzing incidence and frequency of adverse events.
Time frame: 6 weeks and 3, 6, and 12 months after fracture fixation
Oxford Hip Score
Patient-Reported Outcome Measures (PROMs) that document hip function and pain. It's used as a surrogate to assess function and pain of the operated limb.
Time frame: 3, 6, and 12 months after fracture fixation
EQ-5D Health Questionnaire
Patient-reported outcome completed by the patient. It assesses the general health status of the patient and it can be used to derive a quality of life index used for health economics considerations.
Time frame: 3, 6, and 12 months after fracture fixation
Rate of fracture-related infections
Fracture-related infections are diagnosed in accordance with the algorithm described in M McNally, G Govaert, M Dudareva, M Morgenstern, W J Metsemakers, EFORT Open Rev 2020;5:614-619.
Time frame: 6 weeks and 3, 6, and 12 months after fracture fixation
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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