A Study on M2a Magnum Total Hip Arthroplasty

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
M2a Magnum	Total Hip Arthroplasty	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.
M2a Taper	Total Hip Arthroplasty	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.

Primary Outcome Measures

Name	Time	Method
Range of Motion	1 year	Hip Flexion Angle at 1 year postoperatively

Secondary Outcome Measures

Name	Time	Method
Metal Ion	5 year	Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.
UCLA Activity Score	5 year	UCLA is physician assessing scoring system to assess patient's activity level. Minimum score is 0 (completely inactive) and maximum score is 9 (Regularly participates in impact sports) with 1 point increments depending on patient's activity level. Higher score means higher activity level achieved.
Radiographic Assessment	5 year	number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)
Harris Hip Score	5 year	Harris Hip Score is physician assessing hip functional scoring system, which includes 4 components (pain, function, deformity and range of motion) with minimum score of 0 \& maximum score of 100. Maximum \& Minimum score of each subscale is pain: 0-44, function: 0-47, Deformity: 0-4 and Range of motion: 0-5. Current report uses summed score of each patient to compare total Harris Hip Score. Higher score means better outcomes.