NCT00589485

Brief Summary

The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
withdrawn

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, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 9, 2008

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

Same day

First QC Date

December 21, 2007

Last Update Submit

June 19, 2017

Conditions

OsteoarthritisRheumatoid ArthritisTraumatic ArthritisKnee Arthritis

Outcome Measures

Primary Outcomes (1)

  • Radiographic analysis and Knee Society Score

    10 years

Study Arms (2)

1

Device: Simplex® Bone Cement

2

Device: Cobalt™ Bone Cement

Interventions

Simplex® Bone CementDEVICE

This arm will utilize Simplex® Bone Cement in total knee replacement.

1
Cobalt™ Bone CementDEVICE

This arm utilizes Cobalt™ Bone Cement in total knee replacement.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include patients who require total knee replacement.

You may qualify if:

  • Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
  • Patients requiring correction of varus, valgus, or posttraumatic deformity
  • Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

You may not qualify if:

  • Infection, sepsis, and osteomyelitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biomet Orthopedics, LLC

Warsaw, Indiana, 46581, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 9, 2008

Study Start

November 1, 2006

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations

US(1)