Navigation With X3 vs Non-Navigation With X3 Study

Not Applicable

Completed

• Conditions: Degenerative Joint Disease
• Interventions: Device: Trident X3 Insert with Navigation system; Device: Trident X3 Insert with conventional instrumentation

• Registration Number: NCT02543463
• Lead Sponsor: Stryker Japan K.K.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-07
• Primary Completion: 2017-03-31
• Study Completion: 2017-07-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
With Navigation system	Trident X3 Insert with Navigation system	Large diameter head with Trident X3 insert with Navigation system
Without Navigation system	Trident X3 Insert with conventional instrumentation	Large diameter head with Trident X3 insert with conventional instrumentation

Primary Outcome Measures

Name	Time	Method
Range of motion (ROM) during surgery	intraoperative

Secondary Outcome Measures

Name	Time	Method
Measuring accuracy of the ROM during surgery	Intraoperative	Measurement ROM precision of intraoperative
Postoperative dislocation	From intraoperative to 1yr
implantation accuracy	Intraoperative	Measurement of the degree of stem anteversion, cup anteversion and cup abduction

Trial Locations

Locations (1)

Osaka Rosai Hospital; 🇯🇵 Osaka City, Osaka, Japan