Clinical trial NCT01883492: A Prospective Multi-center Study on Total Hip Arthroplasty With E1
Official title: A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Osteoarthritis
Keywords: Only Female
Age between 20 - 75 at the time of operation
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-06-21
Enrollment: 153
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
timeFrame: Immediate postoperative and 2 year postoperatively
Secondary outcomes:
measure: Harris Hip Score at 6 Month Follow-up Visit
timeFrame: 6 month postoperative
measure: Harris Hip Score at 1 Year Follow-up Visit
timeFrame: 1 year postoperative
measure: Harris Hip Score at 2 Year Follow-up Visit
timeFrame: 2 year postoperative
measure: Harris Hip Score at 3 Year Follow-up Visit
timeFrame: 3 year postoperative
measure: WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
timeFrame: 6 month postoperative
measure: WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
timeFrame: 1 year postoperative
measure: WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
timeFrame: 2 year postoperative
measure: WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
timeFrame: 3 year postoperative
measure: UCLA Activity Score at 6 Month Follow-up Visit
timeFrame: 6 month postoperative
measure: UCLA Activity Score at 1 Year Follow-up Visit
timeFrame: 1 year postoperative
measure: UCLA Activity Score at 2 Year Follow-up Visit
timeFrame: 2 year postoperative
measure: UCLA Activity Score at 3 Year Follow-up Visit
timeFrame: 3 year postoperative
Other outcomes:
Locations:
city: Fukuoka city
country: Japan
facility: Fukuoka University School of Medicine
state: Fukuoka Prefecture
city: Sagamihara City
country: Japan
facility: Kitasato University School of Medicine
state: Kanagawa Prefecture
city: Osaka
country: Japan
facility: Saiseikai Nakatsu Hospital
city: Tokyo
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Tokyo
country: Japan
facility: Keio University School of Medicine
Study officials:
affiliation: Saiseikai Nakatsu Hospital
name: Hirotsugu Ohashi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keio University
name: Arihiko Kanaji, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kitasato University School of Medicine
name: Katsufumi Uchiyama, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kitasato University Kitasato Institute Hospital
name: Hironori Kaneko, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fukuoka University School of Medicine
name: Koichi Kinoshita, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: