New nail for broken hips shows promise in healing
NCT ID NCT05362864
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study looked at a special metal nail used to fix broken hip and thigh bones. The nail has a coating to help prevent infection. Researchers followed 149 adults for 12 months to see how well the bone healed and if there were any problems. The goal was to confirm the nail is safe and works as intended.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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149 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients 18 years or older. * Patient must have a signed EC approved informed consent. * Patient must have a monolateral or bilateral trochanteric, sub-trochanteric, or shaft fracture requiring surgical intervention or osteotomy and be eligible for fixation by intramedullary nailing. * Patient has been or is scheduled to be treated with the ZNN Bactiguard System Cephalomedullary Nail. * Patient must be able and willing to complete the protocol required follow-up. * Patients capable of understanding the surgeon's explanations and following his instructions. Exclusion Criteria: * Skeletally immature patients * 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, subject with alcohol/drug addiction, known to be pregnant or breastfeeding). * Patient anticipated to be non-compliant and/or likely to have problems complying with the follow-up program (e.g. patient with no fixed address, long-distance, plans to move during course of study).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier de Douai
Douai, France, 59507, France
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Hospital Clinico de Valencia
Valencia, Valencia, 46010, Spain
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Hospital Rio Hortega
Valladolid, Castille-La Mancha, 47012, Spain
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Other studies related to the condition(s) this trial covers.
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