Clinical trial NCT05362864: ZNN Bactiguard Cephalomedullary Nails PMCF Study
Official title: Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteotomy
Trochanteric Fractures
Sub-trochanteric Fractures
Femoral Shaft Fracture
Keywords: Bactiguard
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 150
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 patients aged 18 or older with femur fractures or osteotomies implanted with the ZNN Cephalomedullary Nail according to the approved/cleared indications.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Performance of the study device by analyzing fracture/osteotomy healing at 12 months after fracture fixation.
timeFrame: 12 months after fracture fixation
Secondary outcomes:
measure: Safety assessment by recording and analyzing incidence and frequency of adverse events.
timeFrame: 6 weeks and 3, 6, and 12 months after fracture fixation
measure: Oxford Hip Score
timeFrame: 3, 6, and 12 months after fracture fixation
measure: EQ-5D Health Questionnaire
timeFrame: 3, 6, and 12 months after fracture fixation
measure: Rate of fracture-related infections
timeFrame: 6 weeks and 3, 6, and 12 months after fracture fixation
Other outcomes:
Locations:
city: Douai
country: France
facility: Centre Hospitalier de Douai
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
state: Castilla-La Mancha
city: Valencia
country: Spain
facility: Hospital Clinico de Valencia
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: