Overview

This trial is active, not recruiting.

Conditions degenerative joint disease, avascular necrosis
Treatment total hip arthroplasty
Sponsor Biomet, Inc.
Collaborator Biomet Japan, Inc.
Start date November 2009
End date December 2021
Trial size 184 participants
Trial identifier NCT01010763, INT.CR.RROW2

Summary

The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.

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)
Total HIp Arthroplasty using with the M2a Magnum Large Metal Articulation is an ultra-high performance metal-on-metal articulation with a big ball (greater than or equal to 38mm) in acetabulums as small as 44mm.
total hip arthroplasty
Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).
(Active Comparator)
Total Hip Arthroplasty using with the M2a Taper Acetabular System consists of a titanium outer shell with cobalt chromium (Co-Cr-Mo) metallic liner, which articulates with with a cobalt chromium (Co-Cr-Mo) modular femoral head.
total hip arthroplasty
Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).

Primary Outcomes

Measure
Range of Motion
time frame: 1 year

Secondary Outcomes

Measure
Metal Ion
time frame: 3m,6m,1y,2y,3y,4y,5y,7y,10y
HHS, UCLA, EQ5D
time frame: 3m,6m,1y,2y,3y,4y,5y,7y,10y
Radiographic Assessment
time frame: Immediate post-op,3m,6m,1y,2y,3y,4y,5y,7y,10y

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Patients suitable for primary Total Hip Replacement - Patients aged over 20 - Patients with limited co-morbidity- ASA I-III - Patients must be able to understand instructions and be willing to return for follow-up - Patients willing to provide blood and urine samples for metal ion analysis at follow-up Exclusion Criteria: - Pre-existing metal implants - Infection, sepsis, and osteomyelitis - Uncooperative patient or pt with neurologic disorders who are incapable of following directions - Osteoporosis - Metabolic disorders which may impair bone formation - osteomalacia - distant foci of infections which may spread to the implant site - rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram - vascular insufficiency, muscular atrophy, or neuromuscular disease - pregnancy

Additional Information

Official title A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
Principal investigator Kenji Ozono, M.D., Ph.D.
Description There are no clinical studies conducted on its performance in Asian population. Furthermore clinical data is required to support marketing and validate design of M2A Magnum.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Biomet, Inc..