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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):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT01010763
First received: November 5, 2009
Last updated: September 26, 2016
Last verified: September 2016
November 5, 2009
September 26, 2016
November 2009
December 2016   (Final data collection date for primary outcome measure)
Range of Motion [ Time Frame: 1 year ]
  • Range of Motion [ Time Frame: 1 year ]
  • Dislocation Rate [ Time Frame: 5 year ]
Complete list of historical versions of study NCT01010763 on ClinicalTrials.gov Archive Site
  • Metal Ion [ Time Frame: 3m,6m,1y,2y,3y,4y,5y ]
  • UCLA Activity Score, EQ5D [ Time Frame: 3m,6m,1y,2y,3y,4y,5y ]
  • Radiographic Assessment [ Time Frame: Immediate post-op,3m,6m,1y,2y,3y,4y,5y ]
  • Harris Hip Score [ Time Frame: 3m,6m,1y,2y,5y ]
  • Metal Ion [ Time Frame: 3m,6m,1y,2y,5y,7y,10y ]
  • UCLA, EQ5D [ Time Frame: 3m,6m,1y,2y,5y,7y,10y ]
  • Radiographic Assessment [ Time Frame: Immediate post-op,3m,6m,1y,2y,5y,7y,10y ]
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
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Degenerative Joint Disease
  • Avascular Necrosis
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).
  • 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.
    Intervention: Device: Total Hip Arthroplasty
  • 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.
    Intervention: Device: Total Hip Arthroplasty
Ando W, Yamamoto K, Atsumi T, Tamaoki S, Oinuma K, Shiratsuchi H, Tokunaga H, Inaba Y, Kobayashi N, Aihara M, Ohzono K. Comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study. J Orthop. 2015 Jun 10;12(4):228-36. doi: 10.1016/j.jor.2015.05.008. eCollection 2015 Dec.

*   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 2017
December 2016   (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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01010763
INT.CR.RROW2
No
Not Provided
Not Provided
Zimmer Biomet
Zimmer Biomet
Biomet Japan, Inc.
Principal Investigator: Kenji Ozono, M.D., Ph.D. Kansai Rosai Hospital
Zimmer Biomet
September 2016

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