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

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.
• •* 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