Navigation With X3 vs Non-Navigation With X3 Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-07-31

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.

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Detailed Description

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Conditions

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Degenerative Joint Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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With Navigation system

Large diameter head with Trident X3 insert with Navigation system

Group Type OTHER

Trident X3 Insert with Navigation system

Intervention Type DEVICE

Without Navigation system

Large diameter head with Trident X3 insert with conventional instrumentation

Group Type OTHER

Trident X3 Insert with conventional instrumentation

Intervention Type DEVICE

Interventions

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Trident X3 Insert with Navigation system

Intervention Type DEVICE

Trident X3 Insert with conventional instrumentation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No