Degenerative Joint Disease
Conditions
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.
Interventions
DEVICETrident X3 Insert with Navigation system
DEVICETrident X3 Insert with conventional instrumentation
Sponsors
Stryker Japan K.K.
Study design
Allocation
NON_RANDOMIZED
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Range of motion (ROM) during surgery | intraoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measuring accuracy of the ROM during surgery | Intraoperative | Measurement ROM precision of intraoperative |
| implantation accuracy | Intraoperative | Measurement of the degree of stem anteversion, cup anteversion and cup abduction |
| Postoperative dislocation | From intraoperative to 1yr | — |
Countries
Japan
Outcome results
None listed