Large Head X3 Study

Degenerative Joint Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02543437
• Other study ID #: SJCR-OR-1002
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2010
• Est. completion date: July 2019

Study information

• Verified date: September 2018
• Source: Stryker Japan K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: July 2019
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis

Intervention

Device:
• Trident Acetabular X3 Insert

Locations

Country	Name	City	State
Japan	Nagoya Kyoritsu Hospital	Nagoya City	Aichi
Japan	Osaka City General Hospital.	Osaka
Japan	Kyowakai Hospital.	Suita City	Osaka
Japan	Yokohama City University Hospital	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Japan K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion(ROM) (Degree)	Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.	Intraoperative
Primary	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	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