Churchill, J Bone Joint Surg Am 2016 - Clinical and Radiographic Outcomes of the Simpliciti Canal-Sparing Shoulder Arthroplasty System: A Prospective Two-Year Multicenter Study
|
Clinical and Radiographic Outcomes of the Simpliciti Canal-Sparing Shoulder Arthroplasty System: A Prospective Two-Year Multicenter Study
Churchill, Nicholson, et al.·J Bone Joint Surg Am·2016·132 citations
Churchill and colleagues reported 2‑year clinical and radiographic outcomes of the Simpliciti stemless humeral component in anatomic TSA to establish its safety.
Tornier‑funded FDA IDE study: prospective, single‑arm, 14 US sites (16 surgeons), operations July 2011 to November 2012, 149 of 157 patients followed at least 2 years.
Key Findings
Composite success at 24 months was 88.7% (lower 95% CI bound 83.6%), above the 65% performance goal set from a 75% historical stemmed rate minus a 10% margin.
The historical stemmed comparison came from Tornier's unpublished Aequalis post‑market surveillance database, and there was no concurrent control group.
From baseline to 2 years, mean ASES score rose from 38 to 92, age and sex‑adjusted Constant score from 56% to 104%, and VAS pain fell from 5.9 to 0.5 (all p < 0.0001).
The stemless implant went to 157 of 500 (31.4%) primary anatomic TSAs by the study surgeons. Bone quality was judged subjectively at surgery, with no objective test.
At 2 years (n = 149), no humeral component or surviving glenoid showed radiolucent lines, migration, subsidence, osteolysis or loosening, and none was revised for humeral loosening.
Three postoperative revisions were for infection at 4 weeks, subscapularis failure at 15 months and glenoid loosening at 18 months. The nucleus was well fixed in each.
Authors' conclusion
The study demonstrated good results at a minimum of two years following use of the Simpliciti canal-sparing humeral component. Clinical results including the range of motion and the Constant, SST, and ASES scores improved significantly, and radiographic analysis showed no signs of loosening, osteolysis, or subsidence of the humeral components or surviving glenoid components.
Churchill and colleagues reported 2‑year clinical and radiographic outcomes of the Simpliciti stemless humeral component in anatomic TSA to establish its safety.
Tornier‑funded FDA IDE study: prospective, single‑arm, 14 US sites (16 surgeons), operations July 2011 to November 2012, 149 of 157 patients followed at least 2 years.
Key Findings
Composite success at 24 months was 88.7% (lower 95% CI bound 83.6%), above the 65% performance goal set from a 75% historical stemmed rate minus a 10% margin.
The historical stemmed comparison came from Tornier's unpublished Aequalis post‑market surveillance database, and there was no concurrent control group.
From baseline to 2 years, mean ASES score rose from 38 to 92, age and sex‑adjusted Constant score from 56% to 104%, and VAS pain fell from 5.9 to 0.5 (all p < 0.0001).
The stemless implant went to 157 of 500 (31.4%) primary anatomic TSAs by the study surgeons. Bone quality was judged subjectively at surgery, with no objective test.
At 2 years (n = 149), no humeral component or surviving glenoid showed radiolucent lines, migration, subsidence, osteolysis or loosening, and none was revised for humeral loosening.
Three postoperative revisions were for infection at 4 weeks, subscapularis failure at 15 months and glenoid loosening at 18 months. The nucleus was well fixed in each.
Authors' conclusion
The study demonstrated good results at a minimum of two years following use of the Simpliciti canal-sparing humeral component. Clinical results including the range of motion and the Constant, SST, and ASES scores improved significantly, and radiographic analysis showed no signs of loosening, osteolysis, or subsidence of the humeral components or surviving glenoid components.