Large Head X3 Study

The Effect of Large Diameter Head to Prevent Dislocation, and of 3 rd Generation Highly Crosslinked Polyethylene to Reduce Wear in Computer Assisted Total Hip Arthroplasty.

The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is to observe wear resistance performance of X3 over historical liner existing highly crosslinked polyethylene.

Study Overview

• Status: Unknown
• Conditions: Degenerative Joint Disease
• Intervention / Treatment: Device: Trident Acetabular X3 Insert

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 534-0021
    • Osaka City General Hospital.
  • Aichi
    • Nagoya City, Aichi, Japan, 454-0933
      • Nagoya Kyoritsu Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Osaka
    • Suita City, Osaka, Japan, 564-0001
      • Kyowakai 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 primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
2. Patient who has diagnosis of degenerative joint disease and no bacterial infectious disease.
3. Patient whose age is 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing 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 a 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trident Acetabular X3 Insert; 28mm, 32mm and 36mm liner	Device: Trident Acetabular X3 Insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion(ROM) (Degree)	Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.	Intraoperative
Lift Off Distance in Dislocation Maneuver(mm)	Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wear Rate(%)	Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.	1 year, 2 years, 3 years and 5 years after surgery

Collaborators and Investigators

• Sponsor: Stryker Japan K.K.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: September 12, 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-1002