Back to resultsNavigation With X3 vs Non-Navigation With X3 Study
Primary Purpose
Degenerative Joint Disease
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Trident X3 Insert with Navigation system
Trident X3 Insert with conventional instrumentation
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Joint Disease
Eligibility Criteria
Inclusion Criteria:
- Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
- Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
- Patient who is age 20 or over.
- Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
- Patient who is willing to and able to comply with postoperative scheduled evaluations.
Exclusion Criteria:
- Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
- Patient who requires revision surgery of a previously implanted total hip arthroplasty.
- Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
- Patient who is or may be pregnant female.
- Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
- Patient who is immunologically suppressed or receiving chronic steroids.
- Patient who is judged ineligible with specific reason by primary doctor.
Sites / Locations
- Osaka Rosai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
With Navigation system
Without Navigation system
Arm Description
Large diameter head with Trident X3 insert with Navigation system
Large diameter head with Trident X3 insert with conventional instrumentation
Outcomes
Primary Outcome Measures
Range of motion (ROM) during surgery
Secondary Outcome Measures
Measuring accuracy of the ROM during surgery
Measurement ROM precision of intraoperative
implantation accuracy
Measurement of the degree of stem anteversion, cup anteversion and cup abduction
Postoperative dislocation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02543463
Brief Title
Navigation With X3 vs Non-Navigation With X3 Study
Official Title
Comparison X3 Study Between Navi-THA and Non-navi-THA
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Japan K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Joint Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
With Navigation system
Arm Type
Other
Arm Description
Large diameter head with Trident X3 insert with Navigation system
Arm Title
Without Navigation system
Arm Type
Other
Arm Description
Large diameter head with Trident X3 insert with conventional instrumentation
Intervention Type
Device
Intervention Name(s)
Trident X3 Insert with Navigation system
Intervention Type
Device
Intervention Name(s)
Trident X3 Insert with conventional instrumentation
Primary Outcome Measure Information:
Title
Range of motion (ROM) during surgery
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Measuring accuracy of the ROM during surgery
Description
Measurement ROM precision of intraoperative
Time Frame
Intraoperative
Title
implantation accuracy
Description
Measurement of the degree of stem anteversion, cup anteversion and cup abduction
Time Frame
Intraoperative
Title
Postoperative dislocation
Time Frame
From intraoperative to 1yr
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
Patient who is age 20 or over.
Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
Patient who is willing to and able to comply with postoperative scheduled evaluations.
Exclusion Criteria:
Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
Patient who requires revision surgery of a previously implanted total hip arthroplasty.
Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
Patient who is or may be pregnant female.
Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
Patient who is immunologically suppressed or receiving chronic steroids.
Patient who is judged ineligible with specific reason by primary doctor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasuyuki Inatsugu
Organizational Affiliation
Stryker Japan
Official's Role
Study Director
Facility Information:
Facility Name
Osaka Rosai Hospital
City
Osaka City
State/Province
Osaka
ZIP/Postal Code
591-8025
Country
Japan
12. IPD Sharing Statement
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Navigation With X3 vs Non-Navigation With X3 Study
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