NCT01336595

Brief Summary

The purpose of this study is to determine if there are any clinical or radiographic differences in cemented total knee arthroplasty with an oxidized zirconium and a cobalt-chromium femoral knee component.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
331

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4

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

January 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
Last Updated

October 5, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

April 14, 2011

Last Update Submit

October 4, 2011

Conditions

Osteoarthritis

Keywords

total knee arthroplastyoxidized zirconiumgenesis IIfemoral componentcobalt chrome

Outcome Measures

Primary Outcomes (1)

  • Improvement in Knee Society Knee Score

    change in knee score will be compared with initial score, until mean follow up of 20 years.

    Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Secondary Outcomes (1)

  • Improvement in the range of motion

    Initial(one day before surgery), and at 3 months, 1 year, then annually after surgery

Study Arms (2)

Zirconium Femoral Component

EXPERIMENTAL

Oxidized zirconium femoral component of Genesis II TKR system is used.

Device: Zirconium (Zirconium Genesis II)

Cobalt Chrome

ACTIVE COMPARATOR

Cobalt-Chromium Femoral component of Genesis II system is used.

Device: Cobalt-Chrome (Cobalt Chrome Genesis II)

Interventions

Zirconium (Zirconium Genesis II)DEVICE

Oxidized Zirconium femoral component of Genesis II TKR system is used.

Also known as: Zirconium Genesis II
Zirconium Femoral Component
Cobalt-Chrome (Cobalt Chrome Genesis II)DEVICE

Cobalt Chrome Femoral Component of Genesis II TKR system is used

Also known as: Cobalt Chrome Genesis II
Cobalt Chrome

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

You may not qualify if:

  • Inflammatory disease
  • patient with other Lower extremity disease which may affect functional outcome
  • Neurologic disease effecting patients lower extremity
  • Revision surgery
  • Patient not medically cleared for bilateral surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hosptial

Seoul, South Korea

Location

Related Publications (2)

  • Ezzet KA, Hermida JC, Colwell CW Jr, D'Lima DD. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res. 2004 Nov;(428):120-4. doi: 10.1097/01.blo.0000148576.70780.13.

    PMID: 15534531BACKGROUND

  • Good V, Ries M, Barrack RL, Widding K, Hunter G, Heuer D. Reduced wear with oxidized zirconium femoral heads. J Bone Joint Surg Am. 2003;85-A Suppl 4:105-10. doi: 10.2106/00004623-200300004-00013. No abstract available.

    PMID: 14652400BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jang-Won Park, MD

    Ewha Womans University Mokdong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 18, 2011

Study Start

January 1, 2003

Primary Completion

March 1, 2004

Study Completion

April 1, 2011

Last Updated

October 5, 2011

Record last verified: 2011-10

Locations

KR(1)