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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex); Device: legacy posterior stabilized standard (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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 158-710
    • Ewha Womans University Mokdong Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: NexGen LPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ewha Womans University

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (ACTUAL): April 1, 2001
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: August 23, 2011
• First Submitted That Met QC Criteria: August 23, 2011
• First Posted (ESTIMATE): August 24, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2011
• Last Update Submitted That Met QC Criteria: August 29, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption; Osteolysis
• Other Study ID Numbers: LPS-Flex vs LPS