THP Hip Fracture Plating System

Primary Endpoint:

• Revision rate due to device related complication(s) or non-union of the femur.

Secondary Endpoints:

• Radiographic and clinical fracture healing of the proximal femur using standard scoring
methods.

Inclusion Criteria:

- Patient must be 18 years of age or older.

- Patient must be eligible for an open reduction and internal fixation of the proximal
femur.

- Patient must have an intracapsular or intertrochanteric fracture.

- Patient must have need for alignment, stabilization, and reduction of bone fractures.

- Patient must have ability and willingness to follow postoperative care instructions
until healing is complete.

- Patient must be in good nutritional state.

- Patient must be able and willing to sign the IRB/EC approved informed consent.

Exclusion Criteria:

- Patient is a prisoner.

- Patient is a current alcohol or drug abuser.

- Patient is known to be pregnant or breastfeeding.

- Patient has a psychiatric illness or cognitive deficit that will not allow proper
informed consent.

- Infection.

- Patient conditions including bloody supply limitations, obesity or insufficient
quantity or quality of bone.

- Patient with mental or neurologic conditions who are unwilling or incapable of
following postoperative care instructions.

- Patient has foreign body sensitivity. Where material sensitivity is suspected or
unknown, testing is to be completed prior to implantation of the device.

- Patient is expected to be non-compliant with recommended post-operative weight-bearing
instructions.