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Long-Term Outcomes of Hybrid Glenoid Compared With a Pegged Implant

IRB Number: 2019-1818

April 08, 2020

Institutional Review Board, Hospital for Special Surgery

The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.

For further information, see Understanding Clinical Trials/Research Studies.

Principal Investigator

Lawrence V. Gulotta, MD

Co-Investigators

Harry G.Greditzer, IV, MD
Russell F. Warren, MD
David M. Dines, MD
Joshua S. Dines, MD
Edward V. Craig, MD, MPH - Emeritus
Jennifer Estrada
Anthony Finocchiaro
Sridhar Pinnamaneni 
Laurence Okeke
Evan Vellios 

 

Summary

This study will include 83 patients who underwent shoulder arthroplasty with hybrid glenoid component versus traditional pegged implant and were included in the prior short-term outcomes study published in 2015. 

Inclusion/Exclusion Criteria

Patients that are candidates for this study must satisfy the following criteria:

  • Between, January 1st 2009 and June 30th 2010, all patients who underwent shoulder arthroplasty with hybrid glenoid component versus traditional pegged implant and were included in the prior short-term outcomes study published in 2015. All these patients will be sourced from the HSS Total Shoulder Registry.
  • Initial Pre-operative exam and imaging consistent with end-stage glenohumeral arthritis 
  • Patients were given initial pre-operative questionnaire that included demographic information, history of present illness, social history, detailed medical history, and surgical history.
  • Patients completed 2 year post-op ASES and VAS scores. 
  • Intra-operative data documented (Walch classification, glenoid version, tearing of biceps, rotator cuff integrity characteristics, additional procedures)

Exclusion criteria include:

  • Patients without 2 year post-op ASES/VAS Scores, patients who refused to participate in prior short-term follow-up study.

Contact Information

Laurence Okeke
Research Assistant
Okekel@hss.edu
212.774.2497