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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.
The objective of this prospective PMCF study is to collect data to confirm safety, performance and clinical benefits of the Zimmer Natural Nail (ZNN) Bactiguard Retrograde Femoral Nail (implants and instrumentation) when used for the temporary internal fixation and stabilization of femoral fractures.
The primary endpoint is the assessment of performance by analyzing fracture healing.
The secondary endpoints are the assessment of safety, clinical benefit and post-op 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZNN Bactiguard Retrograde Femoral Nail | Patients implanted with a ZNN Bactiguard Retrograde Femoral Nail for fixing and stabilizing a femoral fracture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZNN Bactiguard Retrograde Femoral Nail | Device | Femoral fracture internal fixation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of fracture healing 12 months after fracture fixation | Fracture healing is assessed with x-ray imaging and clinical examination. Radiographic Union-Scale in Tibial fractures (RUST) score adapted for the femur, A/P and lateral views. Range: 4 - 12. Fracture healing is defined as RUST scores greater than or equal to 6. Fix-IT score (clinical examination). Range 0 - 12, higher scores indicate better limb function. | 3, 6, and 12 months after fracture fixation |
| Measure | Description | Time Frame |
|---|---|---|
| Oxford Knee Score (limb function) | Range: 0 - 48, higher scores indicate better function. Patient-reported outcome to evaluate the function of the limb treated with ZNN Bactiguard Femur Retrograde. | 3, 6, and 12 months after fracture fixation |
| EQ-5D-5L score (patient's quality of life) |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive series of 18-year-old patients or older with femur fractures implanted with a ZNN Bactiguard Retrograde Femoral Nail according to the approved/cleared indications.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gemma de Ramon Francàs | Contact | +41 79 377 11 96 | gemma.deramonfrancas@zimmerbiomet.com | |
| Emilie Rohmer | Contact | +41 79 368 91 28 | emilie.rohmer@zimmerbiomet.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Ntra. Sra. de Candelaria | Active, not recruiting | Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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Range: 0 - 100, higher scores indicate better quality of life. Patient-reported outcome to evaluate quality of life. |
| pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation |
| Adverse events frequency | The incidence and frequency of adverse events occurring during the study will be reported. | 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. | 12 months after fracture fixation |
| Leeds General Infirmary | Recruiting | Leeds | LEEDS | LS1 3EX | United Kingdom |
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| Manchester Royal Infirmary | Recruiting | Manchester | United Kingdom |
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| Stepping Hill Hospital | Active, not recruiting | Stockport | United Kingdom |