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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Pelvic Alignment Level Instrument Used
No Pelvic Alignment Level Instrument Used
Healthcare Center for Advanced Medicine
Louisville, Kentucky, United States
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.
Time frame: 6 week follow-up
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.
Time frame: 6 week follow-up
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