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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:
ClinicalTrials.gov Identifier:
NCT01422642
First Posted: August 24, 2011
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ewha Womans University
  Purpose
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.

Condition Intervention Phase
Osteoarthritis Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex) Device: legacy posterior stabilized standard (NexGen LPS) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Improvement in Knee Society Knee Score [ Time Frame: 10 years ]
    change in knee score will be compared with initial score, until mean follow up of 10.3 year


Secondary Outcome Measures:
  • Improvement in the range of motion [ Time Frame: 10 years ]
    change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 10.3 years


Enrollment: 111
Study Start Date: January 2001
Study Completion Date: June 2011
Primary Completion Date: April 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: legacy posterior stabilized high-flexion
NexGen LPS-Flex total knee system
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
Experimental: legacy posterior stabilized standard
standard NexGen LPS prosthesis
Device: legacy posterior stabilized standard (NexGen LPS)
NexGen legacy posterior stabilized standard (NexGen LPS) total knee system
Other Name: NexGen LPS

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   48 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422642


Locations
Korea, Republic of
Ewha Womans University Mokdong Hosptial
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University
Investigators
Study Director: Young-Hoo Kim, MD Ewha Womans University School of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT01422642     History of Changes
Other Study ID Numbers: LPS-Flex vs LPS
First Submitted: August 23, 2011
First Posted: August 24, 2011
Last Update Posted: August 30, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Osteoarthritis
Osteolysis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Resorption
Bone Diseases