Back to resultsA Prospective Multi-center Study on Total Hip Arthroplasty With E1
Primary Purpose
Hip Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Femoral Stem
Acetabular Cup
Acetabular Liner
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Only Female, Age between 20 - 75 at the time of operation
Eligibility 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:
- uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- osteoporosis,
- metabolic disorders which may impair bone formation,
- osteomalacia,
- distant foci of infections which may spread to the implant site,
- rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
- vascular insufficiency, muscular atrophy, or neuromuscular disease.
- pregnancy
Sites / Locations
- Fukuoka University School of Medicine
- Kitasato University School of Medicine
- Saiseikai Nakatsu Hospital
- Kitasato University Kitasato Institute Hospital
- Keio University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BIOLOX delta head
CoCr head
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
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
Harris Hip Score at 6 Month Follow-up Visit
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.
Harris Hip Score at 1 Year Follow-up Visit
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.
Harris Hip Score at 2 Year Follow-up Visit
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.
Harris Hip Score at 3 Year Follow-up Visit
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.
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
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.
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
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.
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
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.
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
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.
UCLA Activity Score at 6 Month Follow-up Visit
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.
UCLA Activity Score at 1 Year Follow-up Visit
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.
UCLA Activity Score at 2 Year Follow-up Visit
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.
UCLA Activity Score at 3 Year Follow-up Visit
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01883492
Brief Title
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
Official Title
A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Enrollment of the subject could not reach statistically required number.
Study Start Date
March 11, 2013 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
Only Female, Age between 20 - 75 at the time of operation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIOLOX delta head
Arm Type
Experimental
Arm Description
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.
Arm Title
CoCr head
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Femoral Stem
Other Intervention Name(s)
Taperloc Complete, Taperloc Microplasty Complete, Taperloc Complete XR123, Taperloc Microplasty Complete XR123
Intervention Description
JMDN classification/Class III device
Intervention Type
Device
Intervention Name(s)
Acetabular Cup
Other Intervention Name(s)
Ringloc Acetabular Cup, Regenerex Ringloc+ Acetabular Cup
Intervention Description
JMDN classification: Class III device
Intervention Type
Device
Intervention Name(s)
Acetabular Liner
Other Intervention Name(s)
E1 Ringloc Liner
Intervention Description
JMDN classification: Class III device
Primary Outcome Measure Information:
Title
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
Description
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.
Time Frame
Immediate postoperative and 2 year postoperatively
Secondary Outcome Measure Information:
Title
Harris Hip Score at 6 Month Follow-up Visit
Description
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.
Time Frame
6 month postoperative
Title
Harris Hip Score at 1 Year Follow-up Visit
Description
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.
Time Frame
1 year postoperative
Title
Harris Hip Score at 2 Year Follow-up Visit
Description
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.
Time Frame
2 year postoperative
Title
Harris Hip Score at 3 Year Follow-up Visit
Description
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.
Time Frame
3 year postoperative
Title
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
Description
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.
Time Frame
6 month postoperative
Title
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
Description
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.
Time Frame
1 year postoperative
Title
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
Description
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.
Time Frame
2 year postoperative
Title
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
Description
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.
Time Frame
3 year postoperative
Title
UCLA Activity Score at 6 Month Follow-up Visit
Description
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.
Time Frame
6 month postoperative
Title
UCLA Activity Score at 1 Year Follow-up Visit
Description
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.
Time Frame
1 year postoperative
Title
UCLA Activity Score at 2 Year Follow-up Visit
Description
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.
Time Frame
2 year postoperative
Title
UCLA Activity Score at 3 Year Follow-up Visit
Description
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.
Time Frame
3 year postoperative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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:
uncooperative patient or patient with neurologic disorders who are incapable of following directions,
osteoporosis,
metabolic disorders which may impair bone formation,
osteomalacia,
distant foci of infections which may spread to the implant site,
rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
vascular insufficiency, muscular atrophy, or neuromuscular disease.
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hirotsugu Ohashi, M.D., Ph.D.
Organizational Affiliation
Saiseikai Nakatsu Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arihiko Kanaji, M.D., Ph.D.
Organizational Affiliation
Keio University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katsufumi Uchiyama, M.D., Ph.D.
Organizational Affiliation
Kitasato University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hironori Kaneko, M.D., Ph.D.
Organizational Affiliation
Kitasato University Kitasato Institute Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Koichi Kinoshita, M.D., Ph.D.
Organizational Affiliation
Fukuoka University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fukuoka University School of Medicine
City
Fukuoka city
State/Province
Fukuoka Prefecture
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Kitasato University School of Medicine
City
Sagamihara City
State/Province
Kanagawa Prefecture
ZIP/Postal Code
252-0374
Country
Japan
Facility Name
Saiseikai Nakatsu Hospital
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Keio University School of Medicine
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective Multi-center Study on Total Hip Arthroplasty With E1
We'll reach out to this number within 24 hrs