Osteoarthritis, Knee
Conditions
Keywords
osteoarthritis, knee, total knee arthroplasty, range of motion, satisfaction
Brief summary
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
Detailed 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.
Interventions
DEVICENexgen LPS-flex and AGC
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ROM | — |
| Pain | — |
| Satisfaction | — |
| Feel of prosthesis | — |
| Gait analysis | — |
Countries
Denmark
Contacts
Primary ContactHenrik Husted, consultant
Backup ContactKristian Stahl-Otte, consultant
Outcome results
None listed