Navigation With X3 vs Non-Navigation With X3 Study

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Joint Disease
• Intervention / Treatment: Device: Trident X3 Insert with Navigation system; Device: Trident X3 Insert with conventional instrumentation

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Osaka City, Osaka, Japan, 591-8025
      • Osaka Rosai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: With Navigation system; Large diameter head with Trident X3 insert with Navigation system	Device: Trident X3 Insert with Navigation system
Other: Without Navigation system; Large diameter head with Trident X3 insert with conventional instrumentation	Device: Trident X3 Insert with conventional instrumentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stryker Japan K.K.
• Investigators: Study Director: Yasuyuki Inatsugu, Stryker Japan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases
• Other Study ID Numbers: SJCR-OR-1101v2