A Study on M2a Magnum Total Hip Arthroplasty

Zimmer Biomet

Status: Completed

Conditions: Avascular Necrosis; Degenerative Joint Disease

Treatments: Device: Total Hip Arthroplasty

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010763

INT.CR.RROW2

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

184 participants in 2 patient groups

M2a Magnum

Experimental group

Description:

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.

Treatment:

Device: Total Hip Arthroplasty

M2a Taper

Active Comparator group

Description:

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.

Treatment:

Device: Total Hip Arthroplasty