Primary objective:1. Compare the clinical and functional outcome in the function of the knee between resurfacing the patella and not resurfacing the patella in patients with a Vanguard* Complete Knee System (Biomet Orthopedics, Inc.) total kneeā¦
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Pain and function of the knee after TKA either with or without patella
resurfacing (with accelerometer and questionnaire forms)
Secondary outcome
Pain and function of the knee after TKA either with or without patella
resurfacing (with accelerometer and questionnaire forms) measured over time
Background summary
Whether to resurface the patella during total knee arthroplasty (TKA) remains
controversial, as no clear conclusive evidence in favor of one of the
alternatives could be found in studies using only the classic clinical scorings
systems. It is also claimed that the benefit of patella resurfacing or
non-resurfacing may be different for each TKA implant design.
In this protocol we perform a prospectively randomized comparison between TKA
performed either with or without patella resurfacing using both the classical
scoring systems (KSS, Womac and Feller Knee Score) as well as new performance
based functional tests using accelerometers. These objective functional outcome
measurements have shown the ability to detect functional differences between
TKA patients with or without patella resurfacing in a non-randomized
retrospective pilot study.
The study will be performed using the Biomet VanguardTM knee prosthesis, a
design which has not yet been investigated in the literature regarding the
benefits of either resurfacing the patella or retaining the natural patella.
Study objective
Primary objective:
1. Compare the clinical and functional outcome in the function of the knee
between resurfacing the patella and not resurfacing the patella in patients
with a Vanguard* Complete Knee System (Biomet Orthopedics, Inc.) total knee
arthroplasty.
Secondary objectives:
2. Correlate the clinical and functional outcome as derived by scorings systems
and the objective functional movement analysis using a accelerometer.
3. Compare the post-operation recovering profiles as measured by the classic
clinical scores and the movement analysis.
4. Identify the tasks and movements parameters with the highest distinctive
power.
Study design
A prospective, randomized, dubble blind investigation
Study burden and risks
6X 20 minutes to fill in the questionnaires and to perform the accelerometer
gait analysis tasks.
NL
NL
Listed location countries
Age
Inclusion criteria
Patients that are indicated for a TKA
Exclusion criteria
Patients that already have a prior (unicondylar) knee replacement
Patients with severe medical disability limiting the ability to perform the gait analysis tasks
Contra indications for patella resurfacing: patella fracture or patellectomie
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL21579.096.08 |