Exactech has announced that its Equinoxe Humeral Reconstruction Prosthesis (HRP) has significantly improved a range of motion (ROM), pain and outcome scores (PROMs), with zero cases of humeral component loosening.
The US-based company, which produces implants and technologies for joint replacement surgery, has published the two-year outcomes of the retrospective study in the Journal of Shoulder and Elbow Surgery.
Exactech designed Equinoxe HRP for extensive proximal humerus bone loss.
The study evaluated the clinical outcomes of shoulder arthroplasty patients having proximal humeral bone loss. The loss of humeral bone affects implant fixation and joint stability.
Exactech said that the results of the two-year minimum study using the HRP are powerful in comparison to previous modular endoprostheses present in the market that witnessed the loosening of the humeral component.
Exactech extremities SVP Chris Roche said: “With the release of the HRP, we expanded the indications of reverse shoulder arthroplasty to treat patients with proximal humeral bone loss and implemented several patented design features, with the goal of achieving humeral fixation and joint stability in the most challenging of cases.
“While previous bench testing demonstrated that these design features would improve humeral fixation, the results of this two-year minimum multi-centre clinical study demonstrating zero occurrence of humeral loosening provides a definitive validation of our design goals.”
The Equinoxe HRP, which was launched in the US in 2015 and last year in Europe, was created to be hyper-modular. It has many sizes of proximal bodies, mid-shaft extension segments that feature soft tissue attachments, and distal humeral stems to enhance soft tissue fixation and muscle tensioning.
According to the medical device company, the multiple implant options can help surgeons to rebuild humeral resection with lengths ranging from 50mm to 222mm.
The anatomically designed proximal bodies increase deltoid wrapping and moment arms to improve biomechanical advantage and stability by restoring the sites of rotator cuff muscle insertions, Exactech said.
The distal stem collar, which comes in 17 sizes and links to the outside of the humeral bone to augment the humeral stem fixation and offer additional rotational stability, is a key component of the HRP design.
