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

Ewha Womans University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Device: legacy posterior stabilized standard (NexGen LPS); Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex)

Study type: Interventional

Funder types: Other

Identifiers

NCT01422642

LPS-Flex vs LPS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: All

Ages: 48 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 2 patient groups

legacy posterior stabilized high-flexion

Experimental group

Description:

NexGen LPS-Flex total knee system

Treatment:

Device: legacy posterior stabilized high-flexion (NexGen LPS-Flex)

legacy posterior stabilized standard

Experimental group

Description:

standard NexGen LPS prosthesis

Treatment:

Device: legacy posterior stabilized standard (NexGen LPS)