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

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

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

Study Overview

• Status: Terminated
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: Femoral Stem; Device: Acetabular Cup; Device: Acetabular Liner

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.

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 530-0012
    • Saiseikai Nakatsu Hospital
  • Tokyo, Japan, 160-8582
    • Keio University School of Medicine
  • Tokyo, Japan, 108-8642
    • Kitasato University Kitasato Institute Hospital
  • Fukuoka Prefecture
    • Fukuoka city, Fukuoka Prefecture, Japan, 814-0180
      • Fukuoka University School of Medicine
  • Kanagawa Prefecture
    • Sagamihara City, Kanagawa Prefecture, Japan, 252-0374
      • Kitasato University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: E1 Ringloc Liner

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): March 11, 2013
• Primary Completion (Actual): February 6, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: January 31, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Only Female; Age between 20 - 75 at the time of operation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: INT.CR.GH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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