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Trial record 16 of 34 for:    "Osteoarthritis" | ( Map: Japan )

Large Head X3 Study

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ClinicalTrials.gov Identifier: NCT02543437
Recruitment Status : Active, not recruiting
First Posted : September 7, 2015
Results First Posted : April 6, 2016
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Degenerative Joint Disease Device: Trident Acetabular X3 Insert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : July 2010
Actual Primary Completion Date : December 2011
Estimated Study Completion Date : July 2019

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Arm Intervention/treatment
Trident Acetabular X3 Insert
28mm, 32mm and 36mm liner
Device: Trident Acetabular X3 Insert



Primary Outcome Measures :
  1. Range of Motion(ROM) (Degree) [ Time Frame: Intraoperative ]
    Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.

  2. Lift Off Distance in Dislocation Maneuver(mm) [ Time Frame: 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 :
  1. Wear Rate(%) [ Time Frame: 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543437


Locations
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Japan
Nagoya Kyoritsu Hospital
Nagoya City, Aichi, Japan, 454-0933
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Kyowakai Hospital.
Suita City, Osaka, Japan, 564-0001
Osaka City General Hospital.
Osaka, Japan, 534-0021
Sponsors and Collaborators
Stryker Japan K.K.

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Responsible Party: Stryker Japan K.K.
ClinicalTrials.gov Identifier: NCT02543437     History of Changes
Other Study ID Numbers: SJCR-OR-1002
First Posted: September 7, 2015    Key Record Dates
Results First Posted: April 6, 2016
Last Update Posted: October 15, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases