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

Exclusion Criteria28

• 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:
• demographic information
• injury classification
• FRI information
• operative report and device information
• 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