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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883492
Recruitment Status : Terminated (Enrollment of the subject could not reach statistically required number.)
First Posted : June 21, 2013
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
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 : 153 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
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : March 15, 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 Between Immediate Postoperative and 2 Year Postoperative Period [ Time Frame: Immediate postoperative and 2 year postoperatively ]
    Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.


Secondary Outcome Measures :
  1. Harris Hip Score at 6 Month Follow-up Visit [ Time Frame: 6 month postoperative ]

    Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

    Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.


  2. Harris Hip Score at 1 Year Follow-up Visit [ Time Frame: 1 year postoperative ]

    Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

    Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.


  3. Harris Hip Score at 2 Year Follow-up Visit [ Time Frame: 2 year postoperative ]

    Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

    Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.


  4. Harris Hip Score at 3 Year Follow-up Visit [ Time Frame: 3 year postoperative ]

    Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are "pain", "function", "absence of deformity" and "range of hip motion".

    Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.


  5. WOMAC Osteoarthritis Index at 6 Month Follow-up Visit [ Time Frame: 6 month postoperative ]

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

    The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


  6. WOMAC Osteoarthritis Index at 1 Year Follow-up Visit [ Time Frame: 1 year postoperative ]

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

    The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


  7. WOMAC Osteoarthritis Index at 2 Year Follow-up Visit [ Time Frame: 2 year postoperative ]

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

    The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


  8. WOMAC Osteoarthritis Index at 3 Year Follow-up Visit [ Time Frame: 3 year postoperative ]

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items.

    The scores for each subscale are summed up, with a possible score range of 0-20 for "Pain", 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96.

    Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


  9. UCLA Activity Score at 6 Month Follow-up Visit [ Time Frame: 6 month postoperative ]

    University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

    The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.


  10. UCLA Activity Score at 1 Year Follow-up Visit [ Time Frame: 1 year postoperative ]

    University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

    The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.


  11. UCLA Activity Score at 2 Year Follow-up Visit [ Time Frame: 2 year postoperative ]

    University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

    The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.


  12. UCLA Activity Score at 3 Year Follow-up Visit [ Time Frame: 3 year postoperative ]

    University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity.

    The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  Study Documents (Full-Text)

Documents provided by Zimmer Biomet:
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01883492    
Other Study ID Numbers: INT.CR.GH2
First Posted: June 21, 2013    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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:
Layout table for MeSH terms
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases