Navigation With X3 vs Non-Navigation With X3 Study

Degenerative Joint Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543463
• Other study ID #: SJCR-OR-1101v2
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: July 31, 2017

Study information

• Verified date: September 2018
• Source: Stryker Japan K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• Trident X3 Insert with Navigation system

• Trident X3 Insert with conventional instrumentation

Locations

Country	Name	City	State
Japan	Osaka Rosai Hospital	Osaka City	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of motion (ROM) during surgery		intraoperative
Secondary	Measuring accuracy of the ROM during surgery	Measurement ROM precision of intraoperative	Intraoperative
Secondary	implantation accuracy	Measurement of the degree of stem anteversion, cup anteversion and cup abduction	Intraoperative
Secondary	Postoperative dislocation		From intraoperative to 1yr