Clinical trial NCT05276674: ZNN Bactiguard Retrograde Femoral Nails PMCF Study
Official title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Retrograde Femoral Nails (Implants and Instrumentation)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Femoral Fracture
Keywords: Bactiguard
Femur fracture
Intramedullary nailing
Infection control
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of fracture healing 12 months after fracture fixation
timeFrame: 3, 6, and 12 months after fracture fixation
Secondary outcomes:
measure: Oxford Knee Score (limb function)
timeFrame: 3, 6, and 12 months after fracture fixation
measure: EQ-5D-5L score (patient's quality of life)
timeFrame: pre-surgery (retrospectively), 3, 6, and 12 months after fracture fixation
measure: Adverse events frequency
timeFrame: 12 months after fracture fixation
measure: Rate of fracture-related infections
timeFrame: 12 months after fracture fixation
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Ntra. Sra. de Candelaria
state: Tenerife
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Stockport
country: United Kingdom
facility: Stepping Hill Hospital
Study officials:
References: