Primary Objective: to investigate whether image-based ROSA procedures, which require more preparation time from the surgeon, reduce operation duration and required materials in the operation ward, as compared to imageless procedures, for which ROSA…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Operation ward occupation duration (*exit patient #0* to *exit patient #1*,
with patient #0 having no TKA or comparable procedure, and patient #1 being
operated with ROSA), preparation duration (entry patient to incision), and
duration of surgery (incision to *end of surgery*).
Secondary outcome
Logistical Outcomes: Coordination with anaesthesia/recovery ward, number of
instrument trays used, number of cases until Zimmer-Biomet support is no longer
needed, type of previous and following surgery. Operation ward occupation
duration for stand-alone ROSA-procedures (prior and consequent surgeries in
ward are not TKAs), and for consequent TKA- or ROSA-procedures.
Procedural Outcomes: Accuracy of surgical plan (#adaptations, #procedures
without deviations from plan) including alignment (deviation, #outliers),
implant size, and level of resection. Perioperative outcomes include
#complications, blood loss, length of hospital stay, medication, use of
anaesthesia, analgesia. ROSA outcomes include stability, implant position,
mobility, mechanical axis of the leg (data analysed at end of OR procedure).
Clinical Outcomes: 90-day survival implant, survival patient, reason for
revision, type of revision, complications, Oxford Knee Score, Knee Society
Score, European Quality of Life Questionnaire 5-Dimensions-5L, Visual Analogue
Scale for pain, Pain Catastrophizing Scale, Pain Sensitivity Questionnaire
Background summary
In 2015, an estimated 30 million adults suffered from osteoarthritis (OA).
Thereby, this disease accounts for 3% of all hospitalizations and for 20% of
all health care expenditures.1 Advanced OA requires total knee arthroplasty
(TKA). In developed countries, the mean utilization rate of TKA is estimated to
be 150-200 cases per 100.000 population in 2019,2 and the trend for annual knee
arthroplasties is increasing.3
Modern technology applied during surgeries is designed to further improve
placement and alignment of the implants, and thereby reducing short- and
long-term complications as well as improving patient-reported outcomes. While
patient-specific instrumentation has demonstrated promising, yet not convincing
results, newest technologies combine the development of surgical plans with
peri-operative assessments of outcomes. The first studies of robot-assisted
TKAs (RA-TKA) indeed demonstrated better short-term clinical outcomes when
compared to conventional manual technique with reduction in radiographic
outliers and reduced risks of iatrogenic soft tissues injuries (reduced blood
loss and postoperative drainage)4. Few studies suggest that costs and operative
time were higher for RA-TKA, but these costs may be offset by clinical
improvement and reduced health care utilization in the 90-day period after
surgery.5, 6 From a health care provider perspective, purchase of these
systems, utilization within institutions required to accompany a variety of
surgeries, and manpower to maintain and utilize these systems still adds
significant costs. These costs may be reduced by efficient utilization, eg
appropriate utilization of the variety of programs offered by these
technologies and scheduling.
To our knowledge, no study has assessed the logistics of utilizing RA-TKA in a
high-volume, peripheral hospital. Therefore, our aims are to describe
logistical, infrastructural costs of utilizing RA-TKA at Zuyderland Medical
Center of two programs offered by the ROSA-robot which are image-based and
image-less procedures. To understand the causes of efficient utilization, we
will perform a detailed characterization of RA-TKA, including the learning
curve for maximally efficient surgery duration, and durations and personnel
required for ROSA-implementation. Additionally, we will collect data on
procedural, clinical and economic outcomes for 90 days, in order to inform
cost-efficacy of utilizing ROSA over a relevant period of time.
Study objective
Primary Objective: to investigate whether image-based ROSA procedures, which
require more preparation time from the surgeon, reduce operation duration and
required materials in the operation ward, as compared to imageless procedures,
for which ROSA will only be used during the operation to assist in placement of
the prothesis.
Study design
This is a randomized study, in which one orthopedic surgeon will perform 8
image-based and 8 image-less ROSA-assisted TKAs. Patients are recruited at
Zuyderland Medical Center, enrolled pre-operatively and followed up for 90 days
post-surgery.
Intervention
Use or Not-use of an surgery-plan, developed usingt he ROSA-software
Study burden and risks
The clinical benefit of ROSA-assisted surgery has yet only been demonstrated in
cadaveric studies; the risks associated with this study or group allocation are
minimal, because only additional information is offered, and all decisions are
made by the operating surgeons. All procedures are deemed safe for clinical
practice.
Dr. H. van der Hoffplein 1
Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
* Eligible for primary TKA
* age 40-90 years
* Body-Mass-Index 18.5-50.0 kg/m2
* American Society of Anaesthesiologists Class I-III
* Willingness and capability to understand and follow protocol
Exclusion criteria
* Rheuma-/trauma-indicated knee arthroplasty
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 | NL79142.096.21 |