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: January 16, 2014
Last verified: January 2014

November 5, 2009
January 16, 2014
November 2009
December 2021   (final data collection date for primary outcome measure)
Range of Motion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010763 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study on M2a Magnum Total Hip Arthroplasty
A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Degenerative Joint Disease
  • Avascular Necrosis
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
184
April 2022
December 2021   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01010763
ROW2
Yes
Biomet, Inc.
Biomet, Inc.
Biomet Japan, Inc.
Principal Investigator: Kenji Ozono, M.D., Ph.D. Kansai Rosai Hospital
Biomet, Inc.
January 2014

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