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Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?

This study has been completed.
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01422642
First received: August 23, 2011
Last updated: August 29, 2011
Last verified: June 2011
History of Changes

August 23, 2011
August 29, 2011
January 2001
April 2001   (final data collection date for primary outcome measure)
Improvement in Knee Society Knee Score [ Time Frame: 10 years ] [ Designated as safety issue: No ]
change in knee score will be compared with initial score, until mean follow up of 10.3 year
Same as current
Complete list of historical versions of study NCT01422642 on ClinicalTrials.gov Archive Site
Improvement in the range of motion [ Time Frame: 10 years ] [ Designated as safety issue: No ]
change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 10.3 years
Same as current
Not Provided
Not Provided
 
Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis?
Do We Need High-Flexing Total Knee Arthroplasty to Improve the Survivorship and to Decrease the Incidence of Osteolysis? A Minimum of Ten Years of Follow-up

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.

We therefore hypothesized: (1) the survival of the NexGen LPS-Flex prosthesis is better than standard NexGen LPS prosthesis; (2) knee function and range of motion after clinical assessment will be better in the NexGen LPS-Flex group; and (3) the incidence of osteolysis will be lower in the NexGen LPS-Flex prosthesis than standard NexGTne LPS prosthesis.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex)
    NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system
    Other Name: NexGen LPS-Flex
  • Device: legacy posterior stabilized standard (NexGen LPS)
    NexGen legacy posterior stabilized standard (NexGen LPS) total knee system
    Other Name: NexGen LPS
  • Experimental: legacy posterior stabilized high-flexion
    NexGen LPS-Flex total knee system
    Intervention: Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex)
  • Experimental: legacy posterior stabilized standard
    standard NexGen LPS prosthesis
    Intervention: Device: legacy posterior stabilized standard (NexGen LPS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
June 2011
April 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Both
48 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01422642
LPS-Flex vs LPS
No
Not Provided
Ewha Womans University
Not Provided
Study Director: Young-Hoo Kim, MD Ewha Womans University School of Medicine
Ewha Womans University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP