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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Multi-center Randomized Study on Total Hip Replacement With E1

Conditions
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Hip Osteoarthritis

Intervention / Treatment
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* Device: Femoral Stem
* Device: Acetabular Cup
* Device: Acetabular Liner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIOLOX delta head<br>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<br>* JMDN classification/Class III device<br>* Other names: Taperloc Microplasty Complete XR123;Device: Acetabular Cup<br>* JMDN classification: Class III device<br>* Other names: Regenerex Ringloc+ Acetabular Cup;Device: Acetabular Liner<br>* JMDN classification: Class III device<br>* Other names: E1 Ringloc Liner;|
| Active Comparator: CoCr head<br>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<br>* JMDN classification/Class III device<br>* Other names: Taperloc Microplasty Complete XR123;Device: Acetabular Cup<br>* JMDN classification: Class III device<br>* Other names: Regenerex Ringloc+ Acetabular Cup;Device: Acetabular Liner<br>* JMDN classification: Class III device<br>* Other names: E1 Ringloc Liner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Immediate postoperative and 2 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 3 year postoperative | 
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 year postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Only Female, Age between 20 - 75 at the time of operation