Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex Versus AGC

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Device: Nexgen LPS-flex and AGC

Study type: Interventional

Funder types: Other

Identifiers

NCT00294528

1

Details and patient eligibility

About

A randomized blinded study is conducted comparing 2 different knee prostheses. Range of motion (ROM), pain, feel of prosthesis, satisfaction and ability to do daily activities are registered at intervals up to one year postop, where patients are informed on which prosthesis they received.

We want to:

• determine whether an increased ROM is achieved with a high-flex knee compared to a standard knee
• and if so, does it matter

Full description

100 patients operated on with unilateral TKR are included and randomized to either prostheses.

Patients operated on with bilateral simultaneous TKR receive one of each prostheses but are blinded to which prosthesis is on which side. They have gait analyses performed preop and at intervals up to one year.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age below 75 years and active
• preop ROM at least 120 degress flexion
• BMI below 30
• intact ligaments

Exclusion criteria

• below 18 years
• unable to understand language or purpose

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind