N/A
N=118
ROBODOC® Clinical Trials: Long-Term Follow-Up
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01831219 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Presence of Osteolysis — 2; 2 Hips
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Curexo Technology Corporation
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Osteolysis |
2; 2 | — |
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index |
8.44; 11.32 | — |
| SECONDARY Harris Hip Score |
93.49; 89.5 | — |
| SECONDARY Health Status Questionnaire-12 |
683.52; 637.16 | — |
| SECONDARY UCLA Activity Score |
6.09; 5.71 | — |
| SECONDARY Visual Analog Pain Score |
4.69; 6.42 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01831219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.