ROBODOC® Clinical Trials: Long-Term Follow-Up

NCT01831219 | Completed Results

• 1 other identifier: 12-PROTO-01
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Osteoarthritis

Keywords

osteoarthritis; arthroplasty; hip arthroplasty

Outcome Measures

Primary Outcomes (2)

• Presence of Osteolysis

  Presence of osteolysis determined by looking at patient x-rays as described by Gruen et al and Johnson et al.

  14 months

• Western Ontario and McMaster Universities Osteoarthritis Index

  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) will be used to measure clinical outcome. The WOMAC total score ranges 96 (best) to 0 (worst). The WOMAC pain score ranges 0-20, the stiffness score ranges 0-8, and functional limitation score ranges 0-68.

  2 months

Secondary Outcomes (4)

• Harris Hip Score

  2 months

• Health Status Questionnaire-12

  2 months

• UCLA Activity Score

  2 months

• Visual Analog Pain Score

  2 months

Other Outcomes (1)

• Number of Operated Hips That Required Revision/Reoperation

  At follow-up visit (7-20 years post-operatively)

Study Arms (2)

ROBODOC

The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.

Conventional

The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects included in this study will have been enrolled in either the IDE G920035 or the IDE G000071 Clinical Trial and will have completed the follow-up requirements to those trials.

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.

Sponsors & Collaborators

• Curexo Technology Corporation: lead

Study Sites (1)

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Related Publications (1)

• Bargar WL, Bauer A, Borner M. Primary and revision total hip replacement using the Robodoc system. Clin Orthop Relat Res. 1998 Sep;(354):82-91. doi: 10.1097/00003086-199809000-00011.

  PMID: 9755767 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Senior Manager of Clinical Applications
• Organization: Think Surgical

nnetravali@thinksurgical.com

510-249-2339

Study Officials

• William L Bargar, MD

  Department of Orthopaedics, University of California at Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 15, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 11, 2017
• Results First Posted: January 11, 2017

Record last verified: 2016-11

Locations

US (1)