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

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex); Device: legacy posterior stabilized standard (NexGen LPS)

• Registration Number: NCT01422642
• Lead Sponsor: Ewha Womans University

Brief 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.

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 Timeline

• Study Start: 2001-01
• Primary Completion: 2001-04
• Status Verified: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Last Update Submitted: 2011-08-29
• Last Update Posted: 2011-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
legacy posterior stabilized high-flexion	legacy posterior stabilized high-flexion (NexGen LPS-Flex)	NexGen LPS-Flex total knee system
legacy posterior stabilized standard	legacy posterior stabilized standard (NexGen LPS)	standard NexGen LPS prosthesis

Primary Outcome Measures

Name	Time	Method
Improvement in Knee Society Knee Score	10 years	change in knee score will be compared with initial score, until mean follow up of 10.3 year

Secondary Outcome Measures

Name	Time	Method
Improvement in the range of motion	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

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hosptial; 🇰🇷 Seoul, Korea, Republic of