The current study evaluates the OrthoSensor and investigates whether the combination of the Vanguard® Knee System with the OrthoSensor results in a faster recovery and better clinical outcomes during short follow up compared to conventional TKA (…
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Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is determined based on the main research
question, which is *to assess patient outcome in TKA cases with OrthoSensor in
comparison to TKA cases without using OrthoSensor*. Patient outcomes in this
study include X-ray assessment, patient satisfaction, pain and function as
measured by PROMS and objective outcomes as measured by sensor technologies
(IMA and AM). The parameters produced by IMA and AM output are considered the
most relevant outcome parameters, because they are objective, not dominated by
pain and have previously been indicated as having high discriminative and
diagnostic power to differentiate patients with end stage osteoarthritis from
healthy subjects (23,24). From the sensor parameters, the walking speed is the
most relevant. Recent studies showed that the walking speed is a powerful
parameters as walking speed has the highest discriminative power in
differentiating subjects with knee limitations from healthy subjects (23). In
addition walking speed has previously been associated with general health and
well being (19-22). Since the step frequency is 1) highly related to the
walking speed, 2) easier to derive from IMA as it does not require the exact
walked distance to be calculated (in contrast to walking speed) and 3) also
derived from AM measurements, the step frequency is used as most important and
clinically relevant outcome measure. The main study parameter used in this
study is the step frequency.
Moreover the power calculation of this study is based on previous results using
the step frequency as variable.
Secondary outcome
1. Perceived function, measured using KOOS-PS, New-KSS, FJS
2. Patient satisfaction measured using New-KSS
3. Pain measured usingNew-KSS
4. objectively measurde function: IMA Gait test (Step length, Step time
asymmetry, Step time variability, Pelvic obliquity), IMA Sit-stand test (
Bending angle), IMA Block step test (Asymmetry pelvic obliquity).
5. physical activity measured with AM: Quantity (# steps, # transfers, #
walking bouts, # stair climbing events), duration ( Duration walking, Duration
sitting, duration standing, Duration high intense activities), quality
(Intensity of activities, Distribution of walking bouts, Distribution of
sitting events)
6. Prevalence of radiolucency, Location of radiolucency, Osteolysis as measured
on X ray
Background summary
Nine percent of all knee replacements performed, are for a revision due to
complications. Nearly half of all knee revisions can be attributed to a cause
that may be prevented with correct ligament balancing. A balanced knee has many
postoperative advantages. It contributes to improved alignment and stability.
In addition ligament balancing helps to reduce polyethylene wear and aseptic
loosening of the joint. In addition a patient with a balanced knee is more
likely to have increased range of motion and proprioception and decreased pain.
All these factors help to minimize the need for revision surgery. A balanced
knee can be achieved by correct ligament balancing. Different techniques (e.g.
measured resection, balanced resection) and sequences for ligament release have
been reported over the last years. However currently there is no consensus
regarding the best method to produce a balanced knee (5).
Recently a new knee balancing system, able to address and quantify instability
in TKA, the so called *OrthoSensor* VERASENSE**, has been introduced by Biomet.
The Orthosensor is a trial bearing designed for use with the Vanguard® Complete
Knee System, which is embedded with sensors and microelectronics to provide
surgeons with quantifiable, real-time intra-operative data on soft-tissue
balancing and kinetic tracking, through an uninterrupted surgical workflow to
allow for personalized soft-tissue adjustments. The sensors wirelessly transmit
information to a graphic display, allowing surgeons to quantify soft-tissue
loads throughout the range of motion. This enables the surgeon to make informed
adjustments to the soft tissues and implant placement in order to allow for
overall knee balancing. Combining Biomet*s Vanguard ® Knee System with the
OrthoSensor is aimed to take knee replacement surgery to a new level of
precision by providing surgeons with actionable, intraoperative data to
quantify and verify that they balance a knee implant properly during total knee
replacement surgery.
Hypothesis: TKA with orthosensor results in a faster recovery and better
clinical outcomes during short follow up compared to TKA without OrthoSensor.
Study objective
The current study evaluates the OrthoSensor and investigates whether the
combination of the Vanguard® Knee System with the OrthoSensor results in a
faster recovery and better clinical outcomes during short follow up compared
to conventional TKA (Vanguard ® Knee System without Orthosensor).
The primary objective of this study is to assess patient outcomes in TKA cases
with OrthoSensor in comparison to TKA cases without using OrthoSensor. The
assessment will include postoperative recovery, radiography, patient
satisfaction, pain and function.
The secondary objectives of the study is to establish correlations between
intra-operative information related to the use of OrthoSensor parameters and
patient outcomes.
Study design
This study is a prospective randomized blinded clinical study and will be
carried out at the Atrium MC Heerlen, dept. Orthoapedic Surgery & Traumatology.
Patients will be assigned a study number, blinded for the investigator. These
study numbers will be randomized with the use of computer-generated random
numbers (www.randomizer.org). In this way patients are assigned to one of the
two groups: one group receiving TKA with OrthoSensor and one group receiving
TKA without OrthoSensor. In total 150 patients will be included and participate
for a study period of 2 years.
Measurements will be performed at baseline and 6 weeks, 3 months, 6 months,
1year and 2 years after surgery. The measurements consist of written
questionnaires and sensor-based motion measurements.
Intervention
The intervention concerns the use of the OrthoSensor by the surgeon during TKA.
*OrthoSensor* VERASENSE** has recently be introduced by Biomet. It is a trial
bearing designed for use with the Vanguard® Complete Knee System. The
OrthoSensor is embedded with sensors and microelectronics to provide surgeons
with real-time knee kinetic data. The sensors wirelessly transmit information
to a graphic display, allowing surgeons to quantify soft-tissue loads
throughout the range of motion.
Description of the OrthoSensor:
The Kinetic Knee Balancer:
- Two articulations: Vanguard CR & PS
- Three Sizes: 63/67, 71/75, 79/83
- Five thicknesses: 10-18mm (through the use of different shims)
The graphic user interface:
- Housed on a LINK station which includes 27in iMac Screen, Keyboard, Mouse,
Barcode scanner, and a magnet
- Designed to show the surgeon the
o M/L Load: - Central contact point of the load for each condyle
- Numerical and visual representation of average load
Dispersed
o Kinematic tracking
o Tray rotation
o Tiabial A/P slope
o Tibial Varus/valgus tilt
The intervention will not interfere with the usual treatment. The intervention
from this study will not be a substitute for the care. Postoperative treatment
is similar for the intervention group and control group. The only difference is
the use of the OrthoSensor during surgery.
Study burden and risks
As in any surgical procedure, certain risks are associated with total joint
arthroplasty. These risks include but are not limited to: anaesthetic and
post-anaesthetic reactions (such as hyperaemia), allergic reactions to
prophylactic antibiotics or blood transfusions, damage to blood vessels or
nerves or death. Post-operatively, a patient may experience thrombophlebitis,
pulmonary embolus, dislocation, pain, limp, component loosening, osteolysis due
to wear debris or the need for additional surgery. Fracture of the prosthesis
is a potential complication.
As all patients recruited for this study are indicated for primary total knee
arthroplasty with the device described in the protocol anyway, there is no
known risk associated with participating in this study.
Pre-clinical, clinical, and mechanical testing of the used implants indicate
that the above mentioned risks should not occur at a rate greater than that for
any other type of total knee arthroplasty reported in the literature.
Since the hypothesis of this study is *TKA with OrthoSensor results in a
faster recovery and better clinical outcomes (measured by radiography,
patient satisfaction pain and function) during short follow up compared to TKA
without OrthoSensor, patients may benefit from participation, when they are
allocated to the intervention group. So patients operated with the use of the
OrthoSensor may have less pain (high new KSS), may be more satisfied (higher
new KSS subscore), may have better function (e.g. higher step frequency (IMA),
lower KOOS-PS, more daily activity (AM)) and may have better outcomes on
radiographs than the control group.
The measurements take place during the standard controls to the specialist.
Patients do not need to travel extra. We only ask 10-15minutes extra or their
time, after they have visited the specialist. In addition, patients are asked
to wear an activity monitor (size of a USB stick) for 4 successive days. The
activity monitor does not interfer with daily activities. A pilot study even
showed that subjects did not experience the activity monitor as a burden.
Toermalijnring 600
Dordrecht 3316LC
NL
Toermalijnring 600
Dordrecht 3316LC
NL
Listed location countries
Age
Inclusion criteria
- Patients diagnosed with osteoarthritis and indicated for TKA
- Patients treated prospectively with the Vanguard Total Knee System
- Patients providing informed consent
Exclusion criteria
- Age > 75 yrs
- BMI > 35
- Extreme varus valgus
- Patients who had a TKA on contra lateral side within the last 1 year
- Patients who will need lower limb joint replacement for another joint within one year
- Patients who require revision of previously implanted TKA
- Poor medical condition (e.g. patients with malignancy)
- Cognitive problems
- Language problems
- Patients diagnosed with rheumatoid arthritis, posttraumatic arthritis
- Not being eligible for being included due to any other medical conditions as decided by the ortopaedic surgeons of the Atrium MC
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 | NL47062.096.13 |