Investigational device for partial shoulder replacement surgery

Trial ID:
IRB-16-6767
Heinz R. Hoenecke, M.D.
This study is evaluating the safety and effectiveness of the Tornier Pyrocarbon humeral head in people having a partial shoulder joint replacement, also...

Inclusion Criteria

  • Be 22 years of age or older.
  • Have a clinical indication for shoulder arthroplasty
  • Meet all other eligibility criteria

Exclusion Criteria

  • Have active local or systemic infection, sepsis, or osteomyelitis
  • Have had a prior arthroplasty or prior failed rotator cuff repair on the affected shoulder
  • Be taking more than 5mg/day corticosteroids (e.g. prednisone), within 3 months prior to surgery
  • Have a history of renal or hepatic disease.
  • Have any metabolism disorders that could compromise bone formation
  • Be pregnant or plan to become pregnant within the study period

Additional Info

  • Traditional artificial shoulder systems have ball-like humeral heads made of metal. The Tornier humeral head is coated with pyrocarbon that makes it feel more slippery to the touch and smoother than other metals. This goal of this study is to find out if the pyrocarbon material wears better against the socket of the shoulder joint compared to traditional metal devices. All subjects will receive the pyrocarbon humeral head.

Contact Info:

  • Shannon Cyhan
  • cyhan.shannon@scrippshealth.org