ROBODOC® Clinical Trials: Long-Term Follow-Up

Completed

Conditions studied: Osteoarthritis

In brief

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 original study, the surgeon used a cutting tool called a broach and a special hammer on patients who had standard hip replacement operations. For the other patients, the surgeon used a surgical robot which was equipped with a cutting tool, like a drill, to prepare the thigh bone. The purpose of this study is to collect additional information confirming that the surgical robot is safe and effective when used as recommended. Only patients who were enrolled in the original clinical trials are eligible for this study.

Key facts

Study ID

NCT01831219

Run by

Curexo Technology Corporation

People needed

118

Starts

2013-04-01

Expected to finish

2016-01-01

Last updated by the study team

2017-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• There are no exclusion criteria.

Where it is running

• Sutter Institute for Medical Research — Sacramento, California, United States

Full record on ClinicalTrials.gov

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