Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?
1 other identifier
interventional
111
1 country
1
Brief Summary
The purpose of this study is to determine if there are any clinical or ROM differences in total knee arthroplasty with standard NexGen LPS prosthesis and NexGen LPS-Flex prosthesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2001
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 24, 2011
CompletedAugust 30, 2011
June 1, 2011
3 months
August 23, 2011
August 29, 2011
Conditions
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 10.3 year
10 years
Secondary Outcomes (1)
Improvement in the range of motion
10 years
Study Arms (2)
legacy posterior stabilized high-flexion
EXPERIMENTALNexGen LPS-Flex total knee system
legacy posterior stabilized standard
EXPERIMENTALstandard NexGen LPS prosthesis
Interventions
NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system
NexGen legacy posterior stabilized standard (NexGen LPS) total knee system
Eligibility Criteria
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, 158-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Young-Hoo Kim, MD
Ewha Womans University School of Medicine
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
Study Record Dates
First Submitted
August 23, 2011
First Posted
August 24, 2011
Study Start
January 1, 2001
Primary Completion
April 1, 2001
Study Completion
June 1, 2011
Last Updated
August 30, 2011
Record last verified: 2011-06