Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01831219
Other study ID # 12-PROTO-01
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT04657926 - A Trial of APPA in the Treatment of Knee Osteoarthritis Phase 2
Completed NCT02536833 - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects Phase 2
Completed NCT03014037 - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration N/A
Recruiting NCT05937542 - A Qualitative Investigation of CLEAT Participants
Completed NCT03644615 - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis N/A
Recruiting NCT06061367 - Muscles Strength and Gait Parameteres After TKA
Withdrawn NCT04976972 - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT03850665 - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach N/A
Completed NCT02826902 - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial N/A
Completed NCT04402502 - Dynamic 4DCT to Examine Wrist Carpal Mechanics N/A
Completed NCT02923700 - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial Phase 4
Completed NCT04564053 - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants Phase 1
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT05036174 - Diphenhydramine Ointment for Knee Osteoarthritis N/A
Recruiting NCT02912429 - Onlay vs. Inlay Patellofemoral Arthroplasty N/A
Recruiting NCT02666443 - Low Dose Dexamethasone in Supraclavicular Blocks N/A
Active, not recruiting NCT02723929 - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Terminated NCT02820766 - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting N/A
Withdrawn NCT02921594 - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties N/A