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Trial record 18 of 34 for:    "Osteoarthritis" | ( Map: Japan )

A Prospective Multi-center Study on Total Hip Arthroplasty With E1

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ClinicalTrials.gov Identifier: NCT01883492
Recruitment Status : Active, not recruiting
First Posted : June 21, 2013
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:

The primary objectives of this clinical study include:

  • Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1
  • Compare E1 wear used with CoCr and Biolox Delta heads

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Device: Femoral Stem Device: Acetabular Cup Device: Acetabular Liner Not Applicable

Detailed Description:

This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement.

Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases.

Randomization will occur via random number generator by 4 blocks randomization.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
Actual Study Start Date : March 11, 2013
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIOLOX delta head

Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).

Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.

Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.

Device: Femoral Stem
JMDN classification/Class III device
Other Names:
  • Taperloc Complete
  • Taperloc Microplasty Complete
  • Taperloc Complete XR123
  • Taperloc Microplasty Complete XR123

Device: Acetabular Cup
JMDN classification: Class III device
Other Names:
  • Ringloc Acetabular Cup
  • Regenerex Ringloc+ Acetabular Cup

Device: Acetabular Liner
JMDN classification: Class III device
Other Name: E1 Ringloc Liner

Active Comparator: CoCr head

Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).

Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.

CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.

Device: Femoral Stem
JMDN classification/Class III device
Other Names:
  • Taperloc Complete
  • Taperloc Microplasty Complete
  • Taperloc Complete XR123
  • Taperloc Microplasty Complete XR123

Device: Acetabular Cup
JMDN classification: Class III device
Other Names:
  • Ringloc Acetabular Cup
  • Regenerex Ringloc+ Acetabular Cup

Device: Acetabular Liner
JMDN classification: Class III device
Other Name: E1 Ringloc Liner




Primary Outcome Measures :
  1. Polyethylene Wear [ Time Frame: 10year postoperatively ]

Secondary Outcome Measures :
  1. Harris Hip Score [ Time Frame: 6month postoperatively ]
  2. Harris Hip Score [ Time Frame: 1year postoperatively ]
  3. Harris Hip Score [ Time Frame: 2year postoperatively ]
  4. Harris Hip Score [ Time Frame: 3year postoperatively ]
  5. Harris Hip Score [ Time Frame: 5year postoperatively ]
  6. Harris Hip Score [ Time Frame: 7year postoperatively ]
  7. Harris Hip Score [ Time Frame: 10year postoperatively ]
  8. WOMAC osteoarthritis index [ Time Frame: 6month postoperatively ]
  9. WOMAC osteoarthritis index [ Time Frame: 1year postoperatively ]
  10. WOMAC osteoarthritis index [ Time Frame: 2year postoperatively ]
  11. WOMAC osteoarthritis index [ Time Frame: 3year postoperatively ]
  12. WOMAC osteoarthritis index [ Time Frame: 5year postoperatively ]
  13. WOMAC osteoarthritis index [ Time Frame: 7year postoperatively ]
  14. WOMAC osteoarthritis index [ Time Frame: 10year postoperatively ]
  15. UCLA activity score [ Time Frame: 6month postoperatively ]
  16. UCLA activity score [ Time Frame: 1year postoperatively ]
  17. UCLA activity score [ Time Frame: 2year postoperatively ]
  18. UCLA activity score [ Time Frame: 3year postoperatively ]
  19. UCLA activity score [ Time Frame: 5year postoperatively ]
  20. UCLA activity score [ Time Frame: 7year postoperatively ]
  21. UCLA activity score [ Time Frame: 10year postoperatively ]
  22. Radiographic assessment [ Time Frame: 6month postoperatively ]
    component alignment, positioning change osteolysis or other issue(s)

  23. Radiographic assessment [ Time Frame: 1year postoperatively ]
    component alignment, positioning change osteolysis or other issue(s)

  24. Radiographic assessment [ Time Frame: 2year postoperatively ]
    component alignment, positioning change osteolysis or other issue(s)

  25. Radiographic assessment [ Time Frame: 3year postoperatively ]
    component alignment, positioning change osteolysis or other issue(s)

  26. Radiographic assessment [ Time Frame: 5year postoperatively ]
    component alignment, positioning change osteolysis or other issue(s)

  27. Radiographic assessment [ Time Frame: 7year postoperatively ]
    component alignment, positioning change osteolysis or other issue(s)

  28. Radiographic assessment [ Time Frame: 10year postoperatively ]
    component alignment, positioning change osteolysis or other issue(s)

  29. Polyethylene wear [ Time Frame: 6 month postoperatively ]
  30. Polyethylene wear [ Time Frame: 1 year postoperatively ]
  31. Polyethylene wear [ Time Frame: 2 year postoperatively ]
  32. Polyethylene wear [ Time Frame: 3 year postoperatively ]
  33. Polyethylene wear [ Time Frame: 5 year postoperatively ]
  34. Polyethylene wear [ Time Frame: 7 year postoperatively ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis
  • Age between 20 - 75 at the time of operation
  • Patients with limited co-morbidity -ASA I-III
  • Patients must be able to understand instructions and be willing to return for follow up

Exclusion Criteria:

  • In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System.

Absolute contraindications include: infection, sepsis, and osteomyelitis.

Relative contraindications include:

  1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
  2. osteoporosis,
  3. metabolic disorders which may impair bone formation,
  4. osteomalacia,
  5. distant foci of infections which may spread to the implant site,
  6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
  7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
  8. pregnancy

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): NCT01883492


Locations
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Japan
Fukuoka University School of Medicine
Fukuoka city, Fukuoka Prefecture, Japan, 814-0180
Kitasato University School of Medicine
Sagamihara City, Kanagawa Prefecture, Japan, 252-0374
Saiseikai Nakatsu Hospital
Osaka, Japan, 530-0012
Kitasato University Kitasato Institute Hospital
Tokyo, Japan, 108-8642
Keio University School of Medicine
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Hirotsugu Ohashi, M.D., Ph.D. Saiseikai Nakatsu Hospital
Principal Investigator: Arihiko Kanaji, M.D., Ph.D. Keio University
Principal Investigator: Katsufumi Uchiyama, M.D., Ph.D. Kitasato University School of Medicine
Principal Investigator: Hironori Kaneko, M.D., Ph.D. Kitasato University Kitasato Institute Hospital
Principal Investigator: Koichi Kinoshita, M.D., Ph.D. Fukuoka University School of Medicine

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01883492     History of Changes
Other Study ID Numbers: INT.CR.GH2
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Zimmer Biomet:
Only Female
Age between 20 - 75 at the time of operation

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