Overview

This trial is active, not recruiting.

Condition degenerative joint disease
Treatment trident acetabular x3 insert
Sponsor Stryker Japan K.K.
Start date July 2010
End date December 2011
Trial size 120 participants
Trial identifier NCT02543437, SJCR-OR-1002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
X3 28mm, 32mm and 36mm liner
trident acetabular x3 insert

Primary Outcomes

Measure
Range of motion(ROM) (Degree)
time frame: Intraoperative
Lift off distance in dislocation maneuver(mm)
time frame: Intraoperative

Secondary Outcomes

Measure
Wear rate(%)
time frame: 1 year, 2 years, 3 years and 5 years after surgery

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Stryker Japan K.K..