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August 15, 2007

A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of GEM OSI Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

IRB Number: 27081

Institutional Review Board
Hospital for Special Surgery


The safety of study participants is our top priority. The trial is approved and periodically reviewed by an 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, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Andrew J. Elliott, MD

Co-Investigators

Martin J. O’Malley, MD
Inga Zhygalo

Summary

The purpose of this clinical trial is to evaluate the safety and effectiveness of GEM OS1, a synthetic bone graft material, compared to the patient’s own bone in hind-foot and ankle fusion surgery. Normally, using the patient’s own bone requires a second surgical incision and increased time in the operating room, which may mean a greater risk of complications. If this synthetic material (GEM OS1) proves to be as effective and safe as patient’s own bone, additional procedure time and risks can be eliminated, as using patient’s bone as graft will no longer be required.

Your participation will involve a total of 10 study visits over a period of 12 months (7-21 days, and at 6, 9, 12, 16, 24, 36 and 52 weeks) following your scheduled surgery. At weeks 9, 16, 24 and 36, a CT scan (special x-ray) will be taken of the affected foot to get a three-dimensional image of the healing process. 

Inclusion/Exclusion Criteria

Inclusion Criteria:

  • You can participate in this study if you are over 18 years of age and require a bone fusion procedure in your foot and ankle.

Exclusion Criteria:

  • You previously had surgery at the fusion site
  • You are currently taking medications that affect your bone quality (e.g. steroids)
  • You are currently undergoing radio- or chemotherapy treatments
  • You have a metabolic disorder that affects your bone quality
  • You have a tumor at the fusion site or a bony defect that would interfere with bone formation at the fusion site
  • You are suffering from any disease that interferes with your ability to perform daily activities
  • You are allergic to yeast-derived products
  • You are pregnant or plan to become pregnant during the period of the study (1 year)

Contact Information

Andrew J. Elliott, MD
elliotta@hss.edu
212.606.1579

Martin J. O’Malley, MD
omalleym@hss.edu
212.606.1579

Inga Zhygalo
zhygaloi@hss.edu
212.774.7116





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