ROBODOC® CLINICAL TRIALS: LONG-TERM FOLLOW-UP



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:7/16/2013
Start Date:April 2013
End Date:December 2013
Contact:Nathan A Netravali, PhD
Email:nnetravali@robodoc.com
Phone:510-249-2339

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A Follow-Up Study of Subjects Enrolled in the Pin-Based (IDE G920035) and Pinless (IDE G000071) ROBODOC® Surgical System Clinical Trial


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.


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 trial with a 1:1 ROBODOC:control randomization. The IDE G000071 was a
randomized, controlled trial with a 3:1 ROBODOC:control randomization.

B. Selection Criteria Only subjects who were originally enrolled in the IDE G920035 and IDE
G000071 Clinical Trials are eligible to participate in this study. Subjects selected for
this study will have completed a minimum of the 3 month follow-up requirements of the IDE
G920035 and IDE G000071 Clinical Trials. Enrolled subjects must be willing to give a
relevant medical history, undergo a focused physical examination of their operative hip(s),
have an AP and lateral x-ray taken of their operative hip(s) and complete the Harris Hip
Score, SF-12, UCLA Activity Score, VAS pain self-assessment, and Western Ontario and
McMaster Universities Osteoarthritis Index (WOMAC) questionnaires.

The study subject may be reimbursed for reasonable travel expenses associated with their
participation in the study. All requests for reimbursement must be pre-approved by Curexo
Technology Corporation.

C. Data Collection Subjects participating in this study will be asked to visit the study
site to undergo a physical examination of their operative hip(s). During this visit, they
will be asked to give a relevant medical history, have AP and lateral radiographs taken of
their operative hip(s), and complete the Harris Hip Score, SF-12, UCLA Activity Score, VAS
pain self-assessment, and WOMAC questionnaires.

If the subject has obtained AP and lateral radiographs within the last year, these can be
used instead of requiring them to obtain new radiographs specifically for this study.

If the subject is unable or unwilling to come in for the examination, they will be asked to
fill out the Harris Hip Score, SF-12, UCLA Activity Score, VAS pain self-assessment, and
WOMAC questionnaires via mail or over the phone with the Study Nurse/Coordinator.
Additionally, they will be asked to obtain current AP and lateral radiographs taken of their
operative hip(s) with their current orthopaedic surgeon to be transferred to the study site.

D. Blinding An independent radiologist or orthopaedic surgeon, experienced in reading hip
x-rays, who is blinded to the original randomly assigned study group, will read the
follow-up x-rays taken on subjects enrolled in this study.

E. Randomization There will be no further randomization of subjects in this study. Prior
subject records will determine the original study group (ROBODOC or manual control) to which
the subject was randomly assigned in IDE G920035 or IDE G000071.

F. Baseline Measurements No baseline measurements will be collected for this follow-up
study. G. Power and Sample Size The sample size will be determined by the number of
qualifying subjects from the IDE G920035 and IDE G000071 Clinical Trials who can be located
and who agree to participate in this follow-up study. We anticipate approximately 20
patients from IDE G920035 and 30 patients from IDE G000071 to agree to study participation.
This sample size will provide 82% power (α = 0.05, 2-tailed) to detect a 20% (5 versus 2.5,
pooled SD = 3.0) difference between the ROBODOC and control groups on the VAS at the last
available follow-up.

Inclusion Criteria:

- 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 Criteria:

- There are no exclusion criteria.
We found this trial at
1
site
Sacramento, California 95816
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mi
from
Sacramento, CA
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