NCT00294528UnknownPhase 4
Comparing Clinical Outcome of 2 Different Total Knee Prostheses: Nexgen LPS-Flex and AGC
Hvidovre University Hospital1 site in 1 country100 target enrollmentStarted: January 1, 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Satisfaction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Satisfaction
ROM
Pain
Feel of prosthesis
Gait analysis
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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