Femoral Fracture Clinical Trial
Official title:
Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
NCT number | NCT05276674 |
Other study ID # | CME2021-40T |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 23, 2023 |
Est. completion date | November 2026 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 2026 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must be 18 years or older. - Patient must have a femoral fracture (open, closed, monolateral or bilateral) requiring surgical intervention and be eligible for fixation by intramedullary nailing. Patients with delayed treatment (initial treatment by external fixation due to swelling / high energy trauma followed by definitive treatment by intramedullary nail) can also be included. - Patient has been or is scheduled to be treated with the ZNN Bactiguard System Retrograde Femoral Nail. - Patient must be able and willing to complete the protocol required follow-up. - Patient must have a signed EC approved consent. - Patients capable of understanding the surgeon's explanations and following his instructions. Exclusion Criteria: - Skeletally immature patients - A medullary canal obliterated by a previous fracture or tumor - Bone shaft having excessive bow or a deformity - Lack of bone substance or bone quality, which makes stable seating of the implant impossible - All concomitant diseases that can impair the operation, functioning or the success of the implant - Insufficient blood circulation - Infection - Patient is unwilling or unable to give consent. - Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, alcohol/drug addiction, known to be pregnant or breast feeding). - Patient anticipated to be non-compliant and/or likely to have problems with maintaining follow-up program (e.g. patient with no fixed address, long distance, plans to move during course of study). - Not expected to survive the duration of the follow-up program |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds General Infirmary | Leeds |
Lead Sponsor | Collaborator |
---|---|
Zimmer Biomet |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | EQ-5D-5L score (patient's quality of life) | 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 | |
Secondary | Adverse events frequency | The incidence and frequency of adverse events occurring during the study will be reported. | 12 months after fracture fixation | |
Secondary | 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 |
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