Pelvic Alignment Level (PAL) Instrument Evaluation

Total hip replacement (THR) has been a sucessful treatment for cases of degenerative joint
diseases. However, post operative complications such as dislocations, osteolysis, component
wear and migration are still a concern. It has been noted in the scientific literature that
precise acetabular cup position helps reduce such post operative complications. The Pelvic
Alignment Level (PAL) offers this solution by assessing pelvic motion and optimizing implant
position without the need for intra-operative fluoroscopy or a large capital expenditure. The
focus of this study is to evaluate the clinical outcomes (acetabular cup placement, femoral
offset, and leg length) of using the PAL instrument to those without using PAL instrument
during total hip replacement. This will be a prospective, post market, randomized
multi-center clinical study.

Inclusion Criteria:

- Patient has signed an IRB approved, evaluation specific Informed Patient Consent Form.

- Patient is a male or non-pregnant female age 18 years or older at time of enrollment.

- Patient clinically qualifies for total hip arthroplastic surgery, based on physical
examination and medical history.

- Patient must have a diagnosis of: osteoarthritis, traumatic arthritis, avascular
necrosis, slipped capital epiphysis, pelvic fracture, failed fracture fixation or
rheumatoid arthritis.

Exclusion Criteria:

- Patient's anatomy precludes a cup placement of 45° inclination and 20° anteversion.

- Patient has an active infection within the affected hip joint.

- Patient is a prisoner.

- Patient has plans to relocate to another geographic area before the completion of the
evaluation.