A Study on M2a Magnum Total Hip Arthroplasty

This study is ongoing, but not recruiting participants.
Biomet Japan, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
First received: November 5, 2009
Last updated: September 21, 2015
Last verified: September 2015
The purpose of this study includes the investigation of Metal-ion release and Renal Function analysis in M2a Total Hip Arthroplasty.

Condition Intervention
Degenerative Joint Disease
Avascular Necrosis
Device: Total Hip Arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Range of Motion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 184
Study Start Date: November 2009
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: M2a Magnum
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.
Device: 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: M2a Taper
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.
Device: Total Hip Arthroplasty
Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).

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.

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01010763

Kansai Rosai Hospital
Amagasaki, Hyogo Pref., Japan, 660-8511
Sponsors and Collaborators
Biomet, Inc.
Biomet Japan, Inc.
Principal Investigator: Kenji Ozono, M.D., Ph.D. Kansai Rosai Hospital
  More Information

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01010763     History of Changes
Other Study ID Numbers: INT.CR.RROW2 
Study First Received: November 5, 2009
Last Updated: September 21, 2015
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 04, 2016