CClinicalTrials.gg
TerminatedNCT00588887Updated Jun 21, 2017

Total Knee Replacement With Duracon® and Vanguard™ Prostheses

An observational study in Degenerative Arthritis, Osteoarthritis and Rheumatoid Arthritis, sponsored by Biomet Orthopedics, LLC. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-21.

Sponsored by Biomet Orthopedics, LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.

02

Conditions studied

  • Degenerative Arthritis
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Knee Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 150 is close to the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Biomet Orthopedics, LLC is the lead sponsor of 17 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include patients requiring total knee replacement.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with infection, sepsis, or osteomyelitis.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (actual)

Groups and cohorts

  • 1

    Device: Duracon®

  • 2

    Device: Vanguard™

Interventions

  • DeviceDuracon®

    This group utilizes the Duracon® prostheses for total knee replacement.

  • DeviceVanguard™

    This group will utilize the Vanguard™ prostheses for total knee replacement.

06

What researchers measure

Primary outcomes

  1. Range of motion, Knee Society Score, Duration of surgery

    Time frame: 1 year

07

Study locations

1 site
  • Biomet Orthopedics, Inc.
    Warsaw, Indiana 46581, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00588887
Lead sponsor
Biomet Orthopedics, LLC
Collaborators
New Lexington Clinic
Responsible party
Sponsor
First posted
Jan 9, 2008
Start date
Jun 2005
Primary completion
Feb 2008
Completion
Jun 2008
Last update
Jun 21, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion