Primary Objective:To evaluate tibia rotation after TKA with the Vanguard total knee system with either the XP tibia implant compared to thestandard CR tibia implant.Secondary Objective:Comparing operative, clinical and radiological outcome of either…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rotational degrees of freedom of the tibial implant, measured with 3-D motion
analysis after operation and compared
between the XP tibia implant and CR conventional tibia implant
Secondary outcome
Comparing operative, clinical and radiological outcome of either the XP tibia
implant compared to the
standard CR tibia implant.
standard intramedullary alignment guides.
Background summary
The aim of the present prospective randomized clinical trial was to evaluate
and compare the rotational laxity and stiffness
after TKA with or without preservation of the ACL using 3-D motion analysis for
evaluation of rotational biomechanics. We
hypothesized that preservation of the ACL would result in better rotational
stability than TKA without ACL
Study objective
Primary Objective:
To evaluate tibia rotation after TKA with the Vanguard total knee system with
either the XP tibia implant compared to the
standard CR tibia implant.
Secondary Objective:
Comparing operative, clinical and radiological outcome of either the XP tibia
implant compared to the
standard CR tibia implant.
Study design
A prospective, randomized, double blind controlled study.
Study burden and risks
Besides the usual visits to the clinic, we ask the patient to travel four times
to Heerlen for gait analysis. All in all, this
study will last about an hour. The movement analysis uses infrared cameras that
only measures reflective beads (skin
markers) attached on the skin. In addition, the muscle activity is measured
with the aid of an EMG (Electromyogram). This
is a wireless EMG that are NOT using needles and is absolutely pain free.
The risks associated with this research will be nil. Some physically demanding
tests are performed during the analysis. It
may be that this irritation of the knee and has muscle aches as a result. In
the worst case there is a chance tearing the ACL
during the movement tasks. However, the likelihood of this is very small,
because the movements are carried out in a very
controlled situation and which also occur in the daily life.
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
•Indicated for a TKA
•Patients with pre-existing contra lateral knee surgery
•Painful and disabled knee joint resulting from osteoarthritis, rheumatoid
arthritis, or traumatic arthritis where one
or more compartments are involved
•Correction of varus, valgus, or posttraumatic deformity
•Sufficient soft tissue surrounding the knee, including the ACL and PCL
•High need to obtain pain relief and improve function
•Body-mass-index (BMI) <35
•Ability and willingness to follow instructions, including control of weight
and activity level, and to return for followup
evaluations.
•Consent form read, understood and signed by patient.
Exclusion criteria
•BMI =>35
•Use of Anterior Stabilized Bearings or Posterior Stabilized Bearings
•Patients with severe pre-operative varus or valgus deformity =>15 degrees
•Correction or revision of previous joint replacement procedure on index knee
•Sepsis
•Osteomyelitis
•Active infection in knee
•General infection
•Distant foci of infections which may spread to the implant site
•Failure of previous joint replacement
•Pregnancy
•Previous major knee surgery, except for arthroscopic meniscectomy.
•Metal near knee joint (MRI-scan not possible)
•Rheumatoid arthritis
•Extension deficit >15 degrees
•Flexion <100 degrees.
•Non-correctable varus axis
•Cruciate ligament insufficiency
•Rapid joint destruction, marked bone loss, or bone resorption apparent on
roentgenogram
•Uncooperative patient or patient with neurological disorders who is incapable
of following directions
• Osteoporosis, metabolic disorders and osteomalacia on the basis of the X-ray
which is evaluated by the
orthopedic surgeon
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 | NL72272.096.19 |