ZNN Bactiguard Cephalomedullary Nails PMCF Study
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|ClinicalTrials.gov Identifier: NCT05362864|
Recruitment Status : Not yet recruiting
First Posted : May 5, 2022
Last Update Posted : July 6, 2022
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.
|Condition or disease||Intervention/treatment|
|Osteotomy Trochanteric Fractures Sub-trochanteric Fractures Femoral Shaft Fracture||Procedure: Fracture fixation via Intramedullary Nailing|
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series|
|Estimated Study Start Date :||December 1, 2022|
|Estimated Primary Completion Date :||December 1, 2025|
|Estimated Study Completion Date :||December 1, 2025|
ZNN Bactiguard CMN
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. [ Time Frame: 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.
- Safety assessment by recording and analyzing incidence and frequency of adverse events. [ Time Frame: 6 weeks and 3, 6, and 12 months after fracture fixation ]Recording and analyzing incidence and frequency of adverse events.
- Oxford Hip Score [ Time Frame: 3, 6, and 12 months after fracture fixation ]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.
- EQ-5D Health Questionnaire [ Time Frame: 3, 6, and 12 months after fracture fixation ]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.
- Rate of fracture-related infections [ Time Frame: 6 weeks and 3, 6, and 12 months after fracture fixation ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05362864
|Contact: Gemma de Ramon Francàsfirstname.lastname@example.org|
|Study Director:||Hassan Achakri||Zimmer Biomet|