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

Hip Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01883492
• Other study ID #: INT.CR.GH2
• Status: Terminated
• Phase: N/A
• Start date: March 11, 2013
• Est. completion date: March 15, 2019

Study information

• Verified date: February 2020
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 153
• Est. completion date: March 15, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• Femoral Stem
JMDN classification/Class III device
• Acetabular Cup
JMDN classification: Class III device
• Acetabular Liner
JMDN classification: Class III device

Locations

Country	Name	City	State
Japan	Fukuoka University School of Medicine	Fukuoka city	Fukuoka Prefecture
Japan	Saiseikai Nakatsu Hospital	Osaka
Japan	Kitasato University School of Medicine	Sagamihara City	Kanagawa Prefecture
Japan	Keio University School of Medicine	Tokyo
Japan	Kitasato University Kitasato Institute Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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