Pelvic Alignment Level (PAL) Instrument Evaluation

Study Overview
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Brief Summary
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The study is conducted to evaluate the performance of the Pelvic Alignment Level (PAL) instrument in achieving desired acetabular position, desired leg length and offset after Total Hip Replacement (THR) reconstruction.

Detailed Description
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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.

Official Title
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A Prospective Clinical Evaluation of Acetabular Cup Placement in Total Hip Replacements Utilizing a Pelvic Alignment Level (PAL) Instrument

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Device: Pelvic Alignment Level (PAL) Instrument
* Device: No Pelvic Alignment Level (PAL) Instrument


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pelvic Alignment Level (PAL)<br>Pelvic Alignment Level Instrument Used | Device: Pelvic Alignment Level (PAL) Instrument<br>* Pelvic Alignment Level Instrument Used<br>|
| Other: No Pelvic Alignment Level (PAL)<br>No Pelvic Alignment Level Instrument Used | Device: No Pelvic Alignment Level (PAL) Instrument<br>* No Pelvic Alignment Level Instrument Used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Surgical Accuracy in Placing Acetabular Components at a Target of 45° Inclination and 20° Anteversion While Using the PAL Compared to Surgeries Without Using the PAL Instrument. |  | 6 week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Surgical Success of Achieving Preoperative Targets for Leg Length and Femoral Offset, or be Able to Document Changes to Pre-operative Leg Length and Offset, Using the PAL Compared to Surgeries Without Using the PAL Instrument. |  | 6 week follow-up |