Navigation With X3 vs Non-Navigation With X3 Study

NCT02543463 | Completed

• 1 other identifier: SJCR-OR-1101v2
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Joint Disease

Outcome Measures

Primary Outcomes (1)

• Range of motion (ROM) during surgery

  intraoperative

Secondary Outcomes (3)

• Measuring accuracy of the ROM during surgery

  Intraoperative

• implantation accuracy

  Intraoperative

• Postoperative dislocation

  From intraoperative to 1yr

Study Arms (2)

With Navigation system

OTHER

Large diameter head with Trident X3 insert with Navigation system

Device: Trident X3 Insert with Navigation system

Without Navigation system

OTHER

Large diameter head with Trident X3 insert with conventional instrumentation

Device: Trident X3 Insert with conventional instrumentation

Interventions

Trident X3 Insert with Navigation system DEVICE

With Navigation system

Trident X3 Insert with conventional instrumentation DEVICE

Without Navigation system

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Japan K.K.: lead

Study Sites (1)

Osaka Rosai Hospital

Osaka, Osaka, 591-8025, Japan

Location

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Yasuyuki Inatsugu

  Stryker Japan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: September 7, 2015
• Study Start: April 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: July 31, 2017
• Last Updated: October 29, 2018

Record last verified: 2018-09

Locations

JP (1)