Clinical trial NCT05022485: Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study
Official title: Performance, Safety and Clinical Benefits of a Noble Metal Alloy-coated Intramedullary Nail: a Multicenter, Prospective Trial With a Retrospective Control
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tibial Fractures
Fracture Infection
Keywords: intramedullary tibia nail
Bactiguard
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-year-old patients or older with tibia fractures at high risk for infection (as defined in the inclusion criteria) treated with a titanium-alloy intramedullary nail.

Brief summary: Primary objective of this study is to compare fracture related infection (FRI) rates of ZNN Bactiguard Tibia to conventional uncoated titanium-alloy nails 12 months after tibia fracture fixation.

The secondary objectives are confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation12 months after fracture fixation.

Detailed description: This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study with retrospective controls.

The study will enroll patients that will be implanted with the Zimmer Natural Nail Bactiguard Tibia device and retrospective controls implanted with standard titanium-alloy tibia nails.

500 tibias will be recruited at maximum 15 sites and allocated on a 1:1 ratio into an:

* investigational group (prospective/consecutive series of 250 tibias treated with ZNN Bactiguard tibia)
* a control group (retrospective series of 250 tibias treated with uncoated titanium-alloy tibia nail - data collection will be retrospective, these subjects will not have to undergo any study-related procedure).

The primary endpoint is the Fracture Related Infection (FRI) rate in the study population 12 months after fracture fixation.

The secondary endpoint is the confirmation of safety, performance and clinical benefits of ZNN Bactiguard implant and related instrumentation through the following measure systems:

* Radiologic (RUST) \& clinical (FIX-IT) fracture healing 12 months after fracture fixation (performance).
* Patients' outcomes assessed by the Oxford Knee Score 12 months after fracture fixation (clinical benefits).
* EQ5D-5L (patients' quality of life).
* Incidence and frequency of adverse events (safety).

Data will be collected at 2 weeks, 3 months, 6 months and 1 year after fracture fixation.

Eligibility criteria: Inclusion Criteria:

* Patient must be 18 or older.
* Patient has signed IRB/EC-approved informed consent (if applicable for retrospective controls, based on local requirements).
* Patient suffered primary tibia fracture (monolateral or bilateral) at high risk of infection, eligible for fixation by intramedullary (IM) nailing (standard or suprapatellar approach) and meets at least one of the following conditions:

  * Open fractures (incl. gunshot fractures): Gustilo Type I, II, III A and III B.
  * Delayed treatment (initial treatment by external fixation due to swelling/ high energy trauma followed by definitive treatment by intramedullary nail).
  * Fracture associated with ipsilateral leg compartment syndrome treated with fasciotomy wound(s).
  * Closed fractures with severe tissue damage: Tscherne grade C2 and C3.
* Patient:

  * will be treated with ZNN Bactiguard tibia for inclusion in investigational group (retrospective enrollment is allowed up to 1st follow-up visit);
  * was treated with uncoated (conventional) titanium-alloy intramedullary tibia nail for inclusion in control group;

Exclusion Criteria:

* Patient is unwilling or unable to give consent.
* Patient is not expected to survive follow-up schedule.
* Patient is anticipated to be non-compliant to the study protocol.
* Patient has a mental or neurological condition or alcohol/drug addiction that will not allow for proper informed consent and/or participation in follow-up program.
* Patient is a prisoner.
* Patient is known to be pregnant and/or breastfeeding.
* Patient suffered tibia fracture that meets any of the following conditions:

  * Pathologic fracture.
  * Gustilo Type IIIC open fracture.
  * Patient has multisegmented fracture NOT eligible for fixation by intramedullary nailing.
  * Patients with wound closure more than 10 days after injury.
  * Besides IM nail, patient requires additional tibia fixation by plate (additional tibia fixation by screw(s) and/or fibula plate fixation are allowed).
  * Concomitant with fracture, patient suffered head injury with Abbreviated Injury Score (AIS) ≥ 3.
* For control group:

  * patient doesn't have all the minimum required data available:

    1. demographic information
    2. injury classification
    3. FRI information
    4. operative report and device information
    5. radiographic analyses (until fracture healing or confirmation of non-union leading to reoperation)
* Tibia medullary canal is obliterated by a previous fracture or tumor\*
* Tibia bone shaft having excessive bow or a deformity\*
* Lack of bone substance or bone quality, which makes stable seating of the nail implant impossible\*
* All concomitant diseases that can impair the operation, functioning or the success of the nail implant\*
* Insufficient blood circulation\*
* Skeletally immature patients\*
* Infection\*

  * ZNN Bactiguard tibia contraindication

Primary outcomes:
measure: Fracture related infection (FRI) rate in investigational and control group
timeFrame: 12 months after fracture fixation
Secondary outcomes:
measure: Tibia fracture healing assessed radiologically through Radiographic Union Scale in Tibial fractures (RUST) score
timeFrame: 12 months after fracture fixation
measure: Tibia fracture healing assessed clinically through the Function IndeX for Trauma (FIX-IT) score
timeFrame: 12 months after fracture fixation
measure: Limb functionality measured through the Oxford Knee Score
timeFrame: 12 months after fracture fixation
measure: Quality of life of study participants assessed through the EQ-5D-5L questionnaire
timeFrame: 12 months after fracture fixation
measure: Incidence and frequency of adverse events
timeFrame: 12 months after fracture fixation
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Tirolkliniken Innsbruck
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise-Paré
city: Marseille
country: France
facility: Hôpitaux Universitaires de Marseille Nord
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg
state: Hesse
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Bari
country: Italy
facility: AOU Policlinico di Bari
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Cape Town
country: South Africa
facility: Tygerberg Hospital
city: Cape Town
country: South Africa
facility: Khayelitsha Hospital
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital
city: Barcelona
country: Spain
facility: Hospital Universitario Valle de Hebrón
state: Catalunya
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Zurich
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: King's College Hospital NHS Trust
Study officials:
affiliation: Clin Ops Director
name: Hassan Achakri
role: STUDY_DIRECTOR
References: