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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


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

Ages Eligible for Study:   48 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01422642     History of Changes
Other Study ID Numbers: LPS-Flex vs LPS
Study First Received: August 23, 2011
Last Updated: August 29, 2011
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 17, 2013