THP Hip Fracture Plating System Study

Zimmer Biomet

Status

Terminated

Conditions

Femur Fracture Intertrochanteric

Garden Grade II Subcapital Fracture of Femoral Neck

Femur Fracture

Garden Grade III Subcapital Fracture of Femoral Neck

Garden Grade I Subcapital Fracture of Femoral Neck

Garden Grade IV Subcapital Fracture of Femoral Neck

Treatments

Device: THP Hip Fracture Plating System with telescoping lag screws

Study type

Interventional

Funder types

Industry

Identifiers

NCT03870477

CSU2017-22T

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.