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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Eclipse stemless shoulder prosthesis vs. Univers II shoulder prosthesis: a multicenter, prospective randomized

Anthony A Romeo1, Brandon J Erickson1, John Costouros2

  • 1Department of Orthopaedic Surgery, Rothman Orthopaedic Institute-New York, New York, NY, USA.

Journal of Shoulder and Elbow Surgery
|July 25, 2020
PubMed
Summary

The Arthrex Eclipse shoulder prosthesis is a safe and effective option for glenohumeral arthritis. This stemless implant demonstrated comparable 2-year outcomes to the Univers II prosthesis in a clinical trial.

Keywords:
ArthroplastyEclipseUnivers IIarthritiscomplicationsoutcomesshoulderstemless

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Area of Science:

  • Orthopedic surgery
  • Biomedical engineering
  • Arthroplasty

Background:

  • Total shoulder arthroplasty is a standard treatment for glenohumeral osteoarthritis.
  • The Arthrex Eclipse prosthesis is a stemless, canal-sparing option with bone ingrowth features.
  • It offers diaphyseal and metaphyseal load sharing and fixation.

Purpose of the Study:

  • To evaluate the safety and efficacy of the Arthrex Eclipse shoulder prosthesis.
  • To compare the Eclipse prosthesis with the Arthrex Univers II prosthesis in patients with glenohumeral arthritis.
  • To assess 2-year clinical and radiographic outcomes.

Main Methods:

  • A randomized controlled trial comparing the Eclipse and Univers II prostheses was conducted across 16 US sites.
  • 327 patients with glenohumeral arthritis refractory to conservative treatment were enrolled between 2013 and 2018.
  • Patients were randomized, and strict exclusion criteria were applied to minimize confounding factors.

Main Results:

  • At 2-year follow-up, the Eclipse group showed a 95% success rate versus 89.7% for the Univers II group.
  • No significant radiographic evidence of radiolucency, migration, or subsidence was observed in either group.
  • Reoperation rates were low and comparable between the two groups (3.2% for Eclipse, 3.8% for Univers II).

Conclusions:

  • The Arthrex Eclipse shoulder prosthesis is a safe and effective implant for glenohumeral arthritis.
  • It demonstrates comparable 2-year outcomes to the Univers II shoulder prosthesis.
  • The stemless design and bone ingrowth features contribute to its clinical success.