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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422642
• Other study ID #: LPS-Flex vs LPS
• Status: Completed
• Phase: Phase 4
• First received: August 23, 2011
• Last updated: August 29, 2011
• Start date: January 2001
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 2011
• Est. primary completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 48 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteolysis

Intervention

Device:
• legacy posterior stabilized high-flexion (NexGen LPS-Flex)
NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system
• legacy posterior stabilized standard (NexGen LPS)
NexGen legacy posterior stabilized standard (NexGen LPS) total knee system

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hosptial	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Improvement in the range of motion	change in the range of motion of knee joint will be compared with the initial value, until mean follow up of 10.3 years	10 years	No