A Study on M2a Magnum Total Hip Arthroplasty

Zimmer Biomet184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Degenerative Joint Disease Avascular Necrosis

Interventions

Total Hip ArthroplastyDEVICE

Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Kansai Rosai Hospital

Amagasaki, Hyogo Pref., Japan

Outcomes

Primary Outcomes

Range of Motion

Hip Flexion Angle at 1 year postoperatively

Time frame: 1 year

Secondary Outcomes

Metal Ion

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Time frame: 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.

Time frame: 5 year

Radiographic Assessment

number of participants, whose x-ray shows any signs of radiographic changes (osteolysis, heterotopic ossification and/or radiolucency)

Time frame: 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.

Time frame: 5 year

Metal Ion

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Time frame: 6 month

Metal Ion

Blood Cobalt Ion Concentration 0 was imputed for the measurement result being below detection limit.

Data from ClinicalTrials.gov

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