NCT01010763

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 21, 2019

Completed
Last Updated

June 21, 2019

Status Verified

March 1, 2019

Enrollment Period

7.3 years

First QC Date

November 5, 2009

Results QC Date

October 12, 2017

Last Update Submit

March 26, 2019

Conditions

Degenerative Joint DiseaseAvascular Necrosis

Outcome Measures

Primary Outcomes (1)

  • Range of Motion

    Hip Flexion Angle at 1 year postoperatively

    1 year

Secondary Outcomes (10)

  • Metal Ion

    3 month

  • UCLA Activity Score

    5 year

  • Radiographic Assessment

    5 year

  • Harris Hip Score

    5 year

  • Metal Ion

    6 month

  • +5 more secondary outcomes

Study Arms (2)

M2a Magnum

EXPERIMENTAL

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

M2a Taper

ACTIVE COMPARATOR

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

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).

M2a MagnumM2a Taper

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kansai Rosai Hospital

Amagasaki, Hyogo Pref., 660-8511, Japan

Location

Related Publications (1)

  • 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.

    PMID: 26566324DERIVED

MeSH Terms

Conditions

Joint DiseasesOsteonecrosis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Results Point of Contact

Title
Manager of Clinical Affairs
Organization
Zimmer Biomet G.K.
takahito.nakai@zimmerbiomet.com
+81-3-6402-6610

Study Officials

  • Kenji Ozono, M.D., Ph.D.

    Kansai Rosai Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 10, 2009

Study Start

November 1, 2009

Primary Completion

February 28, 2017

Study Completion

April 28, 2017

Last Updated

June 21, 2019

Results First Posted

June 21, 2019

Record last verified: 2019-03

Locations

JP(1)