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Sidus® Stem-Free Shoulder System

Secure Fixation through a bone-sparing design

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Zimmer Biomet continues to lead the way in bone-preserving arthroplasty solutions with the Sidus Stem-Free Shoulder System. The Sidus System has demonstrated continued success with clinical data from a two year IDE study in the US and Canada1.The studies targeted patients with good bone stock and osteoarthritis.

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Clinically-proven, bone-sparing alternative for Total Shoulder Arthroplasty1

In a two-year analysis of 71 patients from the Sidus IDE Study:

  • 98.5% of patients have over a 30 point improvement on the ASES score from preoperative.
  • Excellent survivorship of 95.8%; three patients underwent revision due to integrity of the subscapularis.
  • 98.5% of patients completing two year visits successfully passed the radiographic success criteria with no progressive radiolucencies of the humeral component >2 mm and no migration or subsidence of the humeral component.

In a two-year analysis of 48 patients from the Bigliani/Flatow® Shoulder Historical Control Study5.

  • 91.7% of patients have over a 30 point improvement on the ASES from preoperative.
  • 97.9% survivorship; one revision due to anterior shoulder pain.
  • 100% of patients completing two year follow-up successfully passed the radiographic success criteria with no progressive radiolucencies of the humeral component >2 mm and no migration or subsidence of the humeral component.

 

Clinical IDE study demonstrated increased mobility and reduced pain compared to preoperative state1

In a two-year analysis of 71 patients from the Sidus IDE Study:

  • Statistically significant improvement in range of motion.
  • Significant improvement in the functions of daily life.
  • 92.6% of the patients were either very satisfied or satisfied at two years post-op.

In a two-year analysis of 48 patients from the Bigliani/Flatow Shoulder Historical Control Study5:

  • Significant improvement in range of motion when compared to preoperative state.
  • Significant improvement in functions of daily life.
  • Satisfaction data was not recorded for Bigliani/Flatow Shoulder.

 

Designed for anatomic flexibility and secure fixation1–3

  • Position of Anchor is independent of humeral canal, enabling optimal coverage and tensioning.
  • Flexibility to mate with a variety of Zimmer Biomet Glenoids.4
  • Anchor geometry and surface finishes designed to resist rotational and lever-out forces.
  • Four open-fin press-fit anchors designed to provide rotational stability and allow for bone through-growth.

An efficient, bone-sparing solution, should revision become necessary

  • Humeral shaft is untouched, minimal bone is removed from the humerus.
  • Anchor contains four large windows for an enhanced view of the humerus, in case of revision.
  • Anchor contains osteotome slots that minimize the impact on bone in case of revision surgery.

 

Procedural efficiency with easy-to-use instrumentation

  • Single-layer tray weighing less than 10 lbs.
  • Streamlined flow of the instruments to mimic the surgical technique.
  • Revision instruments included in the single tray.
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References

  1. Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System (Protocol CIU2012-12E/G130026, “IDE”)
  2. Favre, Philippe, Henderson, Adam D.:Prediction of stemless humeral implant micromotion during upper limb activities. Clinical Biomechanics 36 (2016) 46-51.
  3. Favre, Philippe, Seebeck, Jorn, Thistlethwaite, Paul A E, Obrist, Marc, Steffens, Jason G, Hopkins, Andrew R, Hulme, Paul A. In vitro initial stability of a stemless humeral implant. Clinical Biomechanics 32 (2016) 113-117.
  4. Zimmer Biomet Compatibility Website: http://www.zimmerbiomet.com/medical-professionals/support/product-compatibility.html#shoulder.
  5. Litchfield RB, McKee MD, Balyk R, Mandel S, Holtby R, Hollinshead R, Drosdowech D, Wambolt SE, Griffin SH, McCormack R.: Cemented versus uncemented fixation of humeral components in total shoulder arthroplasty for osteoarthritis of the shoulder: a prospective, randomized, double-blind clinical trial-A JOINTs Canada Project. J Shoulder Elbow Surg. 2011 Jun;20(4):529-36.

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