ZNN Bactiguard Cephalomedullary Nails PMCF Study

Osteotomy Clinical Trial

Official title:

Post-Market Clinical Follow-up Study on the ZNN™ Bactiguard ® Cephalomedullary Nails (Implants and Instrumentation). A Multicenter, Prospective, Consecutive Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05362864
• Other study ID #: CME2021-39T
• Status: Recruiting
• Start date: January 23, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: Gemma de Ramon Francàs
• Phone: +41793771196
• Email: gemma.francas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Femoral Shaft Fracture
• Fractures, Bone
• Hip Fractures
• Osteotomy
• Trochanteric Fractures

Intervention

Procedure:
• Fracture fixation via Intramedullary Nailing
Fixation of trochanteric, sub-trochanteric, and shaft fractures and osteotomies.

Locations

Country	Name	City	State
France	Centre Hospitalier de Douai	Douai

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of the study device by analyzing fracture/osteotomy healing at 12 months after fracture fixation.	Performance will be assessed by analyzing fracture/osteotomy healing at 12 months after fracture fixation. Fracture healing will be assessed clinically and radiologically: Radiological fracture healing is defined as bridging callus on at least three of the four cortices on the AP. and lateral radiographs; Clinical fracture healing is defined as full weight-bearing without pain.	12 months after fracture fixation
Secondary	Safety assessment by recording and analyzing incidence and frequency of adverse events.	Recording and analyzing incidence and frequency of adverse events.	6 weeks and 3, 6, and 12 months after fracture fixation
Secondary	Oxford Hip Score	Patient-Reported Outcome Measures (PROMs) that document hip function and pain. It's used as a surrogate to assess function and pain of the operated limb.	3, 6, and 12 months after fracture fixation
Secondary	EQ-5D Health Questionnaire	Patient-reported outcome completed by the patient. It assesses the general health status of the patient and it can be used to derive a quality of life index used for health economics considerations.	3, 6, and 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.	6 weeks and 3, 6, and 12 months after fracture fixation