A Study on M2a Magnum Total Hip Arthroplasty

NCT ID: NCT01010763

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2017-04-28

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.

Conditions

Degenerative Joint Disease; Avascular Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Total Hip Arthroplasty

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Total Hip Arthroplasty

Intervention Type: DEVICE

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

Interventions

Total Hip Arthroplasty

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenji Ozono, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kansai Rosai Hospital

Locations

Kansai Rosai Hospital

Amagasaki, Hyogo Pref., Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 26566324 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

INT.CR.RROW2

Identifier Type: -

Identifier Source: org_study_id