Hip Innovation Technology Product Testing

     Cadaver Studies

A series of Cadaver Studies were performed with the HRS to assess, among other objectives:

- Ease of Surgical Implantation & Instrument Development

It was determined that the HRS surgical implantation could be performed using all standard surgical approaches. State-of-the-art instruments and practical tray layouts have been designed to further support ease of surgical implantation.

- Establish Biomechanical Equivalence

It was determined that the ratio of the abductor lever arm to gravitational lever arm was .51 to .53 and the force on the femur head was at 2.7 times body weight, all metrics were well within normal limits.

In addition to bench level testing, the Cadaver research results validated that, “The HRS has the same biomechanical characteristics as a normal hip and a well positioned THA”, Victor Frankel, M.D., PhD.

- Anatomical Range of Motion and Stability at normal and mal-positioned acetabular cup placement

In both normal and extreme mal-positioned acetabular cup positions, with various Flexion, Internal and External positions, the HRS was stable and did not impinge or dislocate. See chart below.

    

Surgeon Post Cadaver Study Performance Conclusions

All participating orthopaedic surgeons unanimously agreed with the following post study performance conclusions to be included in FDA Validation Feedback form:

Cadaver Research further validates the HRS forgiving design. The HRS maintained stability in acetabular cup malposition and at extended ranges of motion. The system did not impinge nor dislocate in standard or extreme component positions.