Degenerative Joint Disease
Conditions
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.
Interventions
DEVICETrident Acetabular X3 Insert
Sponsors
Stryker Japan K.K.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient who is a candidate for primary total hip arthroplasty (THA) with cementless acetabular and femoral components. 2. Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease. 3. Patient whose age is 20 or over. 4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form. 5. Patient who is willing 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 a 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion(ROM) (Degree) | Intraoperative | Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation. |
| Lift Off Distance in Dislocation Maneuver(mm) | Intraoperative | Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wear Rate(%) | 1 year, 2 years, 3 years and 5 years after surgery | Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert. |
Countries
Japan
Participant flow
Pre-assignment details
117 participants / 120 hips enrolled in study.
Participants by arm
| Arm | Count |
|---|---|
| X3 Liner X3 28mm, 32mm and 36mm liner
Trident Acetabular X3 Insert | 117 |
| Total | 117 |
Baseline characteristics
| Characteristic | X3 Liner |
|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment Japan | 117 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: Intraoperative
Population: participants with available data : 100 hips in 100 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| X3 Liner | Lift Off Distance in Dislocation Maneuver(mm) | Cup inclination | -0.2 mm | Standard Deviation 3.5 |
| X3 Liner | Lift Off Distance in Dislocation Maneuver(mm) | Cup anteversion | 1.4 mm | Standard Deviation 5.3 |
| X3 Liner | Lift Off Distance in Dislocation Maneuver(mm) | Stem anteversion | -1.2 mm | Standard Deviation 6.4 |
Primary
Range of Motion(ROM) (Degree)
Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.
Time frame: Intraoperative
Population: Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| X3 Liner | Range of Motion(ROM) (Degree) | Maximam Flexion | 2.6 Degree | Standard Deviation 4.5 |
| X3 Liner | Range of Motion(ROM) (Degree) | Maximam Extension | 2.6 Degree | Standard Deviation 4.7 |
| X3 Liner | Range of Motion(ROM) (Degree) | Maximam Abduction | 2.6 Degree | Standard Deviation 4.5 |
Secondary
Wear Rate(%)
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