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Open Label Trial for Treating Carpometacarpal Osteoarthritis: PILOT STUDY - Sub-study on Normal Controls

IRB Number: 23034
inactive

October 16, 2007

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

Lisa A. Mandl, MD, MPH

Co-Investigators

Robert N. Hotchkiss, MD
Francisco Valero-Cuevas, PhD 
Scott W. Wolfe, MD
Edward A. Athanasian, MD
Aaron Daluiski, MD
Sherry Backus, MAPT
Michelle G. Carlson, MD
Stuart Davidson

Summary

20 healthy subjects without thumb osteoarthritis will be recruited.
Subjects will be screened for eligibility through a questionnaire and free hand x-ray and once enrolled will perform a strength and dexterity test and fill out several questionnaires twice, 4 weeks apart.

 

Inclusion/Exclusion Criteria

Inclusion Criteria:
• Over 45 years old. 
• No pain from thumb OA.

Exclusion criteria:
• Radiographic evidence of > 2 Kellgren and Lawrence joint narrowing or osteophytes (on a scale of 0-4), or any sclerosis at the CMC joint.

Contact Information

Stuart Davidson
Clinical Research Coordinator
212.774.2960
davidsons@hss.edu