A Study on M2a Magnum Total Hip Arthroplasty

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Biomet Japan, Inc.

Information provided by (Responsible Party):

Biomet, Inc.

ClinicalTrials.gov Identifier:

NCT01010763

First received: November 5, 2009

Last updated: March 26, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 5, 2009

Last Updated Date

March 26, 2013

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Range of Motion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01010763 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Metal Ion [ Time Frame: 3m,6m,1y,2y,3y,4y,5y,7y,10y ] [ Designated as safety issue: Yes ]
HHS, UCLA, EQ5D [ Time Frame: 3m,6m,1y,2y,3y,4y,5y,7y,10y ] [ Designated as safety issue: No ]
Radiographic Assessment [ Time Frame: Immediate post-op,3m,6m,1y,2y,3y,4y,5y,7y,10y ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Metal Ion [ Time Frame: 3m,6m,1y,2y,5y,7y,10y ] [ Designated as safety issue: Yes ]
UCLA, EQ5D [ Time Frame: 3m,6m,1y,2y,5y,7y,10y ] [ Designated as safety issue: No ]
Radiographic Assessment [ Time Frame: Immediate post-op,3m,6m,1y,2y,5y,7y,10y ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study on M2a Magnum Total Hip Arthroplasty

Official Title ^ICMJE

A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Degenerative Joint Disease
Avascular Necrosis

Intervention ^ICMJE

Device: Metal-on-Metal Articulation
Large metal articulation is an ultra-high performance metal-on-metal articulation with a big ball in acetabulums as small as 44mm
Device: Metal-on-Metal Acetabular System
M2a Taper system consists of a titanium outer shell with cobalt chromium metalic liner

Study Arm (s)

Experimental: M2a Magnum
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.

Intervention: Device: Metal-on-Metal Articulation
Active Comparator: M2a Taper
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.

Intervention: Device: Metal-on-Metal Acetabular System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

184

Estimated Completion Date

December 2021

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01010763

Other Study ID Numbers ^ICMJE

ROW2

Has Data Monitoring Committee

Yes

Responsible Party

Biomet, Inc.

Study Sponsor ^ICMJE

Biomet, Inc.

Collaborators ^ICMJE

Biomet Japan, Inc.

Investigators ^ICMJE

Principal Investigator:

Kenji Ozono, M.D., Ph.D.

Kansai Rosai Hospital

Information Provided By

Biomet, Inc.

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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