THP Hip Fracture Plating System Study

Intracapsular and Intertrochanteric Fracture Fixation With the THP Hip Fracture Plating System

The objective of this study is to systematically document the clinical outcomes of THP Hip Fracture Plating System when used to treat intracapsular and intertrochanteric fractures.

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.