ROBODOC® CLINICAL TRIALS: LONG-TERM FOLLOW-UP

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01831219
• Other study ID #: 12-PROTO-01
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 9, 2013
• Last updated: February 2, 2015
• Start date: April 2013
• Est. completion date: January 2016

Study information

• Verified date: February 2015
• Source: Curexo Technology Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	Sutter Institute for Medical Research	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Curexo Technology Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bargar WL, Bauer A, Börner M. Primary and revision total hip replacement using the Robodoc system. Clin Orthop Relat Res. 1998 Sep;(354):82-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Implant Survivorship	Implant survivorship will be determined from the medical history CRF by comparing the percentage of ROBODOC and manual control subjects who have required revision or re-operation THA procedures on the hip in question since their original study procedure which took place 7-20 years previously.	At follow-up visit (7-20 years post-operatively)	No
Primary	Migration of the implant	Patient x-rays will be evaluated for Migration of the implant as described by Gruen et al and Johnson et al.	14 months	No
Primary	Bone remodeling	Patient x-rays will be evaluated for bone remodeling as described by Gruen et al and Johnson et al.	14 months	No
Primary	Presence of osteolysis	Patient x-rays will be evaluated for presence of osteolysis as described by Gruen et al and Johnson et al.	14 months	No
Primary	Heterotopic bone formation	Patient x-rays will be evaluated for heterotopic bone formation as described by Gruen et al and Johnson et al.	14 months	No
Primary	Stress shielding	Patient x-rays will be evaluated for stress shielding as described by Engh et al.	14 months	No
Primary	Linear polyethylene wear	Patient x-rays will be evaluated for linear polyethylene wear as described by Gruen et al and Johnson et al.	14 months	No
Secondary	Harris Hip Score	The Harris Hip Score will be measured to determine clinical outcome.	2 months	No
Secondary	Health Status Questionnaire-12	The Health Status Questionnaire-12 (HSQ-12) will be used to measure clinical outcome.	2 months	No
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome.	2 months	No
Secondary	UCLA Activity Score	The UCLA Activity Score will be used to measure clinical outcome.	2 months	No
Secondary	Visual Analog Pain Score	The Visual Analog Scale pain questionnaire will be used to measure clinical outcome.	2 months	No