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Predicting Clinical and Patient-Centered Outcomes after Surgery for Degenerative Spondylolisthesis

IRB Number: 2015-237
not enrolling new patients

January 19, 2016

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

Carol A. Mancuso, MD

Co-Investigators

Roland Duculan, MD
Federico P. Girardi, MD  
Darren R. Lebl, MD
Frank P. Cammisa, Jr., MD  
Joseph Nguyen  
Manuela Rigaud  
Alex Fong  
James C. Farmer, MD  
Alexander P. Hughes, MD  
Andrew A. Sama, MD

Summary

This observational study will compare patient-reported outcomes of surgery for lumbar degenerative spondylolisthesis.  A total of 300 patients will be enrolled before surgery and receive a follow-up 2 years after surgery.  The goals are to compare symptoms, function, fulfillment of expectations, and satisfaction with different types of surgery for this condition.

Inclusion/Exclusion Criteria

Patients undergoing surgery for lumbar degenerative spondylolisthesis are eligible if they are at least 18 years old and speak English.

Contact Information

Carol A. Mancuso, MD
212.774.7508
mancusoc@hss.edu