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

Inclusion Criteria:

• Patient must be 18 or older.

• Patient has signed IRB/EC-approved informed consent (if applicable for retrospectivecontrols, based on local requirements).

• Patient suffered primary tibia fracture (monolateral or bilateral) at high risk ofinfection, eligible for fixation by intramedullary (IM) nailing (standard orsuprapatellar 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/ highenergy trauma followed by definitive treatment by intramedullary nail).

• Fracture associated with ipsilateral leg compartment syndrome treated withfasciotomy wound(s).

• Closed fractures with severe tissue damage: Tscherne grade C2 and C3.

• Patient:

• will be treated with ZNN Bactiguard tibia for inclusion in investigationalgroup (retrospective enrollment is allowed up to 1st follow-up visit);

• was treated with uncoated (conventional) titanium-alloy intramedullary tibianail 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 willnot 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 intramedullarynailing.

• 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 areallowed).

• Concomitant with fracture, patient suffered head injury with Abbreviated InjuryScore (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-unionleading 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 nailimplant impossible*

• All concomitant diseases that can impair the operation, functioning or the successof the nail implant*

• Insufficient blood circulation*

• Skeletally immature patients*

• Infection*

• ZNN Bactiguard tibia contraindication