Overview

This trial is active, not recruiting.

Condition hip osteoarthritis
Treatments femoral stem, acetabular cup, acetabular liner
Sponsor Biomet, Inc.
Start date March 2013
End date May 2024
Trial size 148 participants
Trial identifier NCT01883492, INT.CR.GH2

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
femoral stem Taperloc Complete
JMDN classification/Class III device
acetabular cup Ringloc Acetabular Cup
JMDN classification: Class III device
acetabular liner E1 Ringloc Liner
JMDN classification: Class III device
(Active Comparator)
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.
femoral stem Taperloc Complete
JMDN classification/Class III device
acetabular cup Ringloc Acetabular Cup
JMDN classification: Class III device
acetabular liner E1 Ringloc Liner
JMDN classification: Class III device

Primary Outcomes

Measure
Polyethylene Wear
time frame: 10year postoperatively

Secondary Outcomes

Measure
Harris Hip Score
time frame: 6month postoperatively
Harris Hip Score
time frame: 1year postoperatively
Harris Hip Score
time frame: 2year postoperatively
Harris Hip Score
time frame: 3year postoperatively
Harris Hip Score
time frame: 5year postoperatively
Harris Hip Score
time frame: 7year postoperatively
Harris Hip Score
time frame: 10year postoperatively
WOMAC osteoarthritis index
time frame: 6month postoperatively
WOMAC osteoarthritis index
time frame: 1year postoperatively
WOMAC osteoarthritis index
time frame: 2year postoperatively
WOMAC osteoarthritis index
time frame: 3year postoperatively
WOMAC osteoarthritis index
time frame: 5year postoperatively
WOMAC osteoarthritis index
time frame: 7year postoperatively
WOMAC osteoarthritis index
time frame: 10year postoperatively
UCLA activity score
time frame: 6month postoperatively
UCLA activity score
time frame: 1year postoperatively
UCLA activity score
time frame: 2year postoperatively
UCLA activity score
time frame: 3year postoperatively
UCLA activity score
time frame: 5year postoperatively
UCLA activity score
time frame: 7year postoperatively
UCLA activity score
time frame: 10year postoperatively
Radiographic assessment
time frame: 6month postoperatively
Radiographic assessment
time frame: 1year postoperatively
Radiographic assessment
time frame: 2year postoperatively
Radiographic assessment
time frame: 3year postoperatively
Radiographic assessment
time frame: 5year postoperatively
Radiographic assessment
time frame: 7year postoperatively
Radiographic assessment
time frame: 10year postoperatively
Polyethylene wear
time frame: 6 month postoperatively
Polyethylene wear
time frame: 1 year postoperatively
Polyethylene wear
time frame: 2 year postoperatively
Polyethylene wear
time frame: 3 year postoperatively
Polyethylene wear
time frame: 5 year postoperatively
Polyethylene wear
time frame: 7 year postoperatively

Eligibility Criteria

Female participants from 20 years up to 75 years old.

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

Additional Information

Official title A Prospective Multi-center Randomized Study on Total Hip Replacement With E1
Principal investigator Hirotsugu Ohashi, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..