Back to resultsLarge Head X3 Study
Primary Purpose
Degenerative Joint Disease
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Trident Acetabular X3 Insert
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 primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
- Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
- Patient whose age is 20 or over.
- Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
- Patient who is willing 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 a 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
- Nagoya Kyoritsu Hospital
- Yokohama City University Hospital
- Kyowakai Hospital.
- Osaka City General Hospital.
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Trident Acetabular X3 Insert
Arm Description
28mm, 32mm and 36mm liner
Outcomes
Primary Outcome Measures
Range of Motion(ROM) (Degree)
Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Lift Off Distance in Dislocation Maneuver(mm)
Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Secondary Outcome Measures
Wear Rate(%)
Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02543437
Brief Title
Large Head X3 Study
Official Title
The Effect of Large Diameter Head to Prevent Dislocation, and of 3 rd Generation Highly Crosslinked Polyethylene to Reduce Wear in Computer Assisted Total Hip Arthroplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
July 2019 (Anticipated)
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 explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is to observe wear resistance performance of X3 over historical liner existing highly crosslinked polyethylene.
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
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trident Acetabular X3 Insert
Arm Type
Other
Arm Description
28mm, 32mm and 36mm liner
Intervention Type
Device
Intervention Name(s)
Trident Acetabular X3 Insert
Primary Outcome Measure Information:
Title
Range of Motion(ROM) (Degree)
Description
Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Time Frame
Intraoperative
Title
Lift Off Distance in Dislocation Maneuver(mm)
Description
Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Wear Rate(%)
Description
Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.
Time Frame
1 year, 2 years, 3 years and 5 years after surgery
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 primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
Patient whose age is 20 or over.
Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
Patient who is willing 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 a 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.
Facility Information:
Facility Name
Nagoya Kyoritsu Hospital
City
Nagoya City
State/Province
Aichi
ZIP/Postal Code
454-0933
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Facility Name
Kyowakai Hospital.
City
Suita City
State/Province
Osaka
ZIP/Postal Code
564-0001
Country
Japan
Facility Name
Osaka City General Hospital.
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
12. IPD Sharing Statement
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