Total Knee Replacement With Duracon® and Vanguard™ Prostheses
1 other identifier
observational
150
1 country
1
Brief Summary
The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2005
Typical duration for all trials
1 active site
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
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 21, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedJune 21, 2017
June 1, 2017
2.7 years
December 21, 2007
June 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Range of motion, Knee Society Score, Duration of surgery
1 year
Study Arms (2)
1
2
Interventions
Eligibility Criteria
The study population will include patients requiring 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:
- Patients with infection, sepsis, or osteomyelitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biomet Orthopedics, LLClead
- New Lexington Cliniccollaborator
Study Sites (1)
Biomet Orthopedics, Inc.
Warsaw, Indiana, 46581, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
June 1, 2005
Primary Completion
February 1, 2008
Study Completion
June 1, 2008
Last Updated
June 21, 2017
Record last verified: 2017-06