Skip to main content
OpenTrials
Completed

NCT Number: NCT02543463

Navigation With X3 vs Non-Navigation With X3 Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osaka Rosai Hospital

Osaka, 591-8025, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trident X3 Insert with Navigation system

Device

Trident X3 Insert with conventional instrumentation

Device

Primary outcomes

  1. Range of motion (ROM) during surgery

    Time frame: intraoperative

Secondary outcomes

  1. Measuring accuracy of the ROM during surgery

    Time frame: Intraoperative

    Measurement ROM precision of intraoperative

  2. implantation accuracy

    Time frame: Intraoperative

    Measurement of the degree of stem anteversion, cup anteversion and cup abduction

  3. Postoperative dislocation

    Time frame: From intraoperative to 1yr

Sponsors and collaborators

Lead sponsor

Stryker Japan K.K.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2015
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.