Navigation With X3 vs Non-Navigation With X3 Study

Study Overview
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Brief Summary
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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.

Official Title
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Comparison X3 Study Between Navi-THA and Non-navi-THA

Conditions
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Degenerative Joint Disease

Intervention / Treatment
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* Device: Trident X3 Insert with Navigation system
* Device: Trident X3 Insert with conventional instrumentation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: With Navigation system<br>Large diameter head with Trident X3 insert with Navigation system | Device: Trident X3 Insert with Navigation system<br> <br> |
| Other: Without Navigation system<br>Large diameter head with Trident X3 insert with conventional instrumentation | Device: Trident X3 Insert with conventional instrumentation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion (ROM) during surgery |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring accuracy of the ROM during surgery | Measurement ROM precision of intraoperative | Intraoperative | 
| implantation accuracy | Measurement of the degree of stem anteversion, cup anteversion and cup abduction | Intraoperative | 
| Postoperative dislocation |  | From intraoperative to 1yr |