Zimmer® Natural Nail® (ZNN) Bactiguard Tibia Post-Market Clinical Follow-up Study

Launched by ZIMMER BIOMET · Aug 20, 2021

Keywords

ClinConnect Summary

The Zimmer® Natural Nail® (ZNN) Bactiguard Tibia study is looking to understand how well a special type of nail, designed to help heal broken leg bones (specifically the tibia), prevents infections compared to a standard titanium nail. Researchers will follow patients for 12 months after their surgery to see how many develop infections related to their fractures. This study is important because it aims to confirm the safety and effectiveness of the ZNN Bactiguard nail in helping patients heal without complications.

To participate in this trial, patients need to be 18 years or older and have suffered a specific type of tibia fracture that puts them at a higher risk for infection. They will either receive the new ZNN Bactiguard nail or the standard titanium nail. Participants can expect regular follow-up visits to monitor their recovery and any potential issues. It's also important to note that certain conditions, such as being pregnant or having certain medical issues, may exclude someone from participating in the study.

Gender

ALL

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