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

Not Applicable

Terminated

• Conditions: Hip Osteoarthritis
• Interventions: Device: Femoral Stem; Device: Acetabular Cup; Device: Acetabular Liner

• Registration Number: NCT01883492
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2013-01-31
• Study Start: 2013-03-11
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-21
• Primary Completion: 2019-02-06
• Study Completion: 2019-03-15
• Results First Submitted: 2020-01-20
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Results First Posted: 2020-02-17
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 153

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIOLOX delta head	Acetabular Cup	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.
BIOLOX delta head	Acetabular Liner	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.
CoCr head	Femoral Stem	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.
CoCr head	Acetabular Cup	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.
BIOLOX delta head	Femoral Stem	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.
CoCr head	Acetabular Liner	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.

Primary Outcome Measures

Name	Time	Method
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period	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

Name	Time	Method
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit	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.
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit	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.
Harris Hip Score at 1 Year Follow-up Visit	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.
UCLA Activity Score at 6 Month Follow-up Visit	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.
UCLA Activity Score at 1 Year Follow-up Visit	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.
Harris Hip Score at 2 Year Follow-up Visit	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.
Harris Hip Score at 3 Year Follow-up Visit	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.
Harris Hip Score at 6 Month Follow-up Visit	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.
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit	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.
UCLA Activity Score at 3 Year Follow-up Visit	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.
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit	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.
UCLA Activity Score at 2 Year Follow-up Visit	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.

Trial Locations

Locations (5)

Saiseikai Nakatsu Hospital; 🇯🇵 Osaka, Japan

Fukuoka University School of Medicine; 🇯🇵 Fukuoka city, Fukuoka Prefecture, Japan

Kitasato University School of Medicine; 🇯🇵 Sagamihara City, Kanagawa Prefecture, Japan

Kitasato University Kitasato Institute Hospital; 🇯🇵 Tokyo, Japan

Keio University School of Medicine; 🇯🇵 Tokyo, Japan