Real-Time Instrument for Acetabular Shell Positioning

Study Summary

The proposed study is a double-blinded randomized controlled trial comparing Real-time instruments with solely standardized instruments for the placement of the acetabular cup prosthesis used in total hip arthroplasty. The investigators will enroll 44 patients who have consented to total hip arthroplasty for treatment of hip pathology. This treatment is a standard of care. Patients will receive standard of care pre- and post-operative care and placement of standard of care implants all of which are commercially available and FDA approved for general use for the clinical indications used in these patients. All patients will receive a pre-operative CT scan for surgical planning and comparison with post-operative CT scan. The difference in intervention between the groups will be the creation and use of real-time instrument from the pre-operative planning session. These instruments will be used for placement of an indexing peripheral guide wire to direct acetabular preparation and placement of the shell assisting standard surgical instruments. The post-operative scan will be performed within two weeks of the surgery for both the treatment and control groups. The investigators will analyze the difference in acetabular shell placement (acetabular version and abduction angle) from the pre-operatively planned CT scan. These differences will be compared between the control and experimental groups.

Primary Outcome

The overall difference in component placement between standard of care instrumentation and real-time instrumentation will be compared.

Interventions

• DEVICE Real-time Instrumentation
• PROCEDURE Standard Total Hip Arthroplasty