Status:
COMPLETED
ROBODOC® Clinical Trials: Long-Term Follow-Up
Lead Sponsor:
Curexo Technology Corporation
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Brief Summary
This is a follow-up study looking at the and long-term results of two methods of preparing the thigh bone to receive an implant during hip replacement surgery. For one group of patients in the origina...
Detailed Description
A. Description This study is a follow-up study looking at mid- and long-term outcomes for participants in the IDE G920035 and IDE G000071 Clinical Trials. The IDE G920035 was a randomized, controlled ...
Eligibility Criteria
Inclusion
- Subjects included in this study will have completed the follow-up requirements of the IDE G920035 or the IDE G000071 Clinical Trial;
- Subjects must be willing to give a relevant medical history, undergo a focused physical examination of their operative hip(s) and have an AP and lateral x-ray taken of their operative hip(s);
- Subjects must be willing to complete the Harris Hip Score, SF-12, WOMAC, UCLA Activity Score, and VAS pain self-assessment questionnaires; and
- Subjects must be willing to sign an informed consent document.
Exclusion
- There are no exclusion criteria.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01831219
Start Date
April 1 2013
End Date
January 1 2016
Last Update
January 11 2017
Active Locations (1)
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1
Sutter Institute for Medical Research
Sacramento, California, United States, 95816