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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
153
JMDN classification/Class III device
JMDN classification: Class III device
JMDN classification: Class III device
Fukuoka University School of Medicine
Fukuoka, Fukuoka, Japan
Kitasato University School of Medicine
Sagamihara, Kanagawa, Japan
Saiseikai Nakatsu Hospital
Osaka, Japan
Kitasato University Kitasato Institute Hospital
Tokyo, Japan
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.
Time frame: Immediate postoperative and 2 year postoperatively
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.
Time frame: 6 month postoperative
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.
Time frame: 1 year postoperative
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.
Time frame: 2 year postoperative
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.
Time frame: 3 year postoperative
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Keio University School of Medicine
Tokyo, Japan
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.
Time frame: 6 month postoperative
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.
Time frame: 1 year postoperative
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.
Time frame: 2 year postoperative
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.
Time frame: 3 year postoperative
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.
Time frame: 6 month postoperative
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.
Time frame: 1 year postoperative
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.
Time frame: 2 year postoperative
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.
Time frame: 3 year postoperative