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

Zimmer Biomet

Status: Terminated

Conditions: Hip Osteoarthritis

Treatments: Device: Femoral Stem; Device: Acetabular Liner; Device: Acetabular Cup

Study type: Interventional

Funder types: Industry

Identifiers

NCT01883492

INT.CR.GH2

Details and patient eligibility

About

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

Full 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.

Enrollment: 153 patients

Sex: Female

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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153 participants in 2 patient groups

BIOLOX delta head

Experimental group

Description:

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.

Treatment:

Device: Acetabular Cup

Device: Acetabular Liner

Device: Femoral Stem

CoCr head

Active Comparator group

Description:

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.

Treatment:

Device: Acetabular Cup

Device: Acetabular Liner

Device: Femoral Stem