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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01422642

Enrollment

111

Registered

2011-08-24

Start date

2001-01-31

Completion date

2011-06-30

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DEVICElegacy posterior stabilized high-flexion (NexGen LPS-Flex)

NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system

DEVICElegacy posterior stabilized standard (NexGen LPS)

NexGen legacy posterior stabilized standard (NexGen LPS) total knee system

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

48 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026