|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02543463 |
|
Date of registration:
|
10/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Navigation With X3 vs Non-Navigation With X3 Study
|
|
Scientific title:
|
Comparison X3 Study Between Navi-THA and Non-navi-THA |
|
Date of first enrolment:
|
April 2015 |
|
Target sample size:
|
49 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02543463 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Yasuyuki Inatsugu |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Stryker Japan |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless
acetabular and femoral components.
2. Patient who has a diagnosis of degenerative joint disease and no bacterial infectious
disease.
3. Patient who is age 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific
Informed Patient Consent Form.
5. Patient who is willing to and able to comply with postoperative scheduled evaluations.
Exclusion Criteria:
1. Patient who has a bacterial infectious disease or has a high risk of a bacterial
infection.
2. Patient who requires revision surgery of a previously implanted total hip
arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) > 45.
4. Patient who is or may be pregnant female.
5. Patient who has neuromuscular or neurosensory deficiency, which limits ability to
evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Degenerative Joint Disease
|
|
Intervention(s)
|
|
Device: Trident X3 Insert with conventional instrumentation
|
|
Device: Trident X3 Insert with Navigation system
|
|
Primary Outcome(s)
|
|
Range of motion (ROM) during surgery
[Time Frame: intraoperative]
|
|
Secondary Outcome(s)
|
|
implantation accuracy
[Time Frame: Intraoperative]
|
|
Measuring accuracy of the ROM during surgery
[Time Frame: Intraoperative]
|
|
Postoperative dislocation
[Time Frame: From intraoperative to 1yr]
|
|
Secondary ID(s)
|
|
SJCR-OR-1101v2
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|