A Study on M2a Magnum Total Hip Arthroplasty

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.

Official Title
-----------------
A Prospective Controlled Multi-Center Study on M2a Magnum Total Hip Arthroplasty

Conditions
-----------------
Degenerative Joint Disease, Avascular Necrosis

Intervention / Treatment
-----------------
* Device: Total Hip Arthroplasty


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M2a Magnum<br>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. | Device: Total Hip Arthroplasty<br>* Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).<br>|
| Active Comparator: M2a Taper<br>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. | Device: Total Hip Arthroplasty<br>* Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | Hip Flexion Angle at 1 year postoperatively | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 3 month | 
| UCLA Activity Score | 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. | 5 year | 
| Radiographic Assessment | number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency) | 5 year | 
| Harris Hip Score | 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. | 5 year | 
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 6 month | 
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 1 year | 
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 2 year | 
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 3 year | 
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 4 year | 
| Metal Ion | Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit. | 5 year |