Large Head X3 Study

Not Applicable

• Conditions: Degenerative Joint Disease
• Interventions: Device: Trident Acetabular X3 Insert

• Registration Number: NCT02543437
• Lead Sponsor: Stryker Japan K.K.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-12
• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-04
• Study First Posted: 2015-09-07
• Results First Submitted: 2015-09-25
• Results First Submitted QC: 2016-03-07
• Results First Posted: 2016-04-06
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-10-15
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trident Acetabular X3 Insert	Trident Acetabular X3 Insert	28mm, 32mm and 36mm liner

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Nagoya Kyoritsu Hospital; 🇯🇵 Nagoya City, Aichi, Japan

Kyowakai Hospital.; 🇯🇵 Suita City, Osaka, Japan

Yokohama City University Hospital; 🇯🇵 Yokohama, Kanagawa, Japan

Osaka City General Hospital.; 🇯🇵 Osaka, Japan