A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zimmer Biomet
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Range of Motion
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- 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
Arms & Interventions
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: Total Hip Arthroplasty (Device)
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: Total Hip Arthroplasty (Device)
Outcomes
Primary Outcomes
Range of Motion
Time Frame: 1 year
Hip Flexion Angle at 1 year postoperatively
Secondary Outcomes
- Metal Ion(5 year)
- UCLA Activity Score(5 year)
- Radiographic Assessment(5 year)
- Harris Hip Score(5 year)
- Metal Ion(3 month)
- Metal Ion(6 month)
- Metal Ion(1 year)
- Metal Ion(2 year)
- Metal Ion(3 year)
- Metal Ion(4 year)