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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
  Purpose

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: Metal-on-Metal Articulation
Device: Metal-on-Metal Acetabular System

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

Resource links provided by NLM:

U.S. FDA Resources

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: December 2021
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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
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.
 Device: Metal-on-Metal Acetabular System
M2a Taper system consists of a titanium outer shell with cobalt chromium metalic liner

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.

  Eligibility

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

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

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

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01010763     History of Changes
Other Study ID Numbers: ROW2
Study First Received: November 5, 2009
Last Updated: March 26, 2013
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Necrosis
Osteonecrosis
Osteoarthritis
Musculoskeletal Diseases
 Pathologic Processes
Bone Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013