A Study on M2a Magnum Total Hip Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Avascular Necrosis; Degenerative Joint Disease
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hyogo Pref.
    • Amagasaki, Hyogo Pref., Japan, 660-8511
      • Kansai Rosai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Total Hip Arthroplasty; Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).
Active Comparator: 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.	Device: Total Hip Arthroplasty; Degenerated hip is replaced with implantable devices, which include femoral stem, acetabular cup, femoral head and acetabular liner(control group only).

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

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Kenji Ozono, M.D., Ph.D., Kansai Rosai Hospital

Publications and helpful links

General Publications

• Ando W, Yamamoto K, Atsumi T, Tamaoki S, Oinuma K, Shiratsuchi H, Tokunaga H, Inaba Y, Kobayashi N, Aihara M, Ohzono K. Comparison between component designs with different femoral head size in metal-on-metal total hip arthroplasty; multicenter randomized prospective study. J Orthop. 2015 Jun 10;12(4):228-36. doi: 10.1016/j.jor.2015.05.008. eCollection 2015 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2009
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): April 28, 2017

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 9, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Joint Diseases; Necrosis
• Other Study ID Numbers: INT.CR.RROW2