Primary Objective: To investigate if a risk model can be made, based on physical fitness and patient characteristics, to predict the recovery of physical function 6 weeks after total knee arthroplasty.Secondary Objective(s): To explore if this model…
ID
Source
Brief title
Condition
- Other condition
- Bone and joint therapeutic procedures
Synonym
Health condition
gewrichts-aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is postoperative physical function (KOOS) 6 weeks after TKA
surgery. Predicted by physical fitness and patient characteristics measured
during the preoperative assessment. The KOOS is a measurement tool to assess
physical recovery of knee function. It evaluates both short and long-term
outcomes and consists out of 42 items dived in 5 subscales;
- Pain
- Symptoms
- ADL
- Sport-recreation
- Quality of life (QoL)
Determinants:
Numeric rating score (NRS)
Pain
score 0-10
A higher score indicates more pain.
30sec Timed Chair Stand Test (30secTCST)
Lower extremity strength
More repetitions indicate a better strength. Counts the repetitions of making
the transfer from sit to stand during 30 seconds.
2 minute walking test (2MWT)
Walking ability
A longer distance (meters) indicates a better walking ability. Self-paced
walking ability and functional capacity test.
Timed up and go test (TUG)
Walking ability and balance
A shorter time indicates a better walking ability and balance during de
transfer from sit to stand and walking 3 meters.
Hand grip strength (HGS)
Strength
Strength in kilogrammes. Measures maximal hand grip strength with the JAMAR
dynamometer.
De Morton Mobility Index (DEMMI)
Activities
The higher the score, the better the activities. Measures performing activity
tasks independently.
Besides the primary outcome and determinants several other relevant study
parameters will be collected which describe the characteristics of the
participants, like age, sex, body mass index (in kg/m2). Comorbidity will be
recorded using the American Society of Anesthesiologists (ASA) classification
(I-IV, a higher score indicates less fit for surgery).
Secondary outcome
N.A.
Background summary
One of the most common degenerative joint disorders is osteoarthritis (OA). It
is most frequently localized in the knee joint. In 2019, the prevalence of knee
osteoarthritis (KOA) in the Netherlands reached 704.600 patients. The incidence
number will increase with age and is higher in women (29.800) than in men
(18.900) (1). There are several risk factors for the development of KOA, these
can be divided in endogenous (Age; Sex; Heredity; Ethnic origin; Postmenopausal
changes) and exogenous factors (Trauma; Overweight; Restrictive joint surgery;
Lifestyle factors) (2).
Progressive loss of joint cartilage, osteophyte formation and sclerosis of the
subchondral bone leads to reduced mobility, strength, instability and pain (3).
This results in limitations in activities of daily life (ADL), work and leisure
(3, 4). The treatments of KOA always starts with a conservative approach. If
the conservative approach does not produce sufficient results, joint
replacement surgery can be considered (5). Total knee arthroplasty or
replacement (TKA/TKR) is regarded as the gold standard for the treatment of KOA
(6). In 2019 TKR was performed 25.881 times in the Netherlands. In 2020 there
was seen a drop in surgeries due to COVID-19. Nevertheless, 19.501 TKR*s were
performed (7). Predictions with incidence numbers from 1997-2005 predict 57.893
TKR*s in 2030, that is an increase of 297% (8).
Due to the increase in patients with KOA, healthcare costs are rising. Of all
these costs, 54% are spent in hospital care (3). The hospital care is
constantly evaluating in order to cope with the influx of patients and in order
to be able to continue and deliver the most optimized care. Therefore enhanced
recovery pathways such as enhanced recovery after surgery (ERAS), fast track,
and rapid recovery were developed (9). The idea behind these different
multidisciplinary pathways is a reduction of postoperative physical and
psychological stress and thereby a reduction in length of stay (LOS) and
healthcare costs (9). The first positive results of an enhanced recovery
pathway was found in high-risk elderly patients who underwent colonic surgery
(10). Enhanced recovery in elective orthopedic arthroplasties showed a
decreased LOS from 5-11 days to <= 4 days (11).
A study in total hip replacements has shown that physical fitness before
surgery is a major predictor of postoperative inpatient recovery (12). A
cluster of physical measurements was used to distinguish between patients with
high and low risk on postoperative inpatient delayed recovery. Delayed
inpatient recovery manifests itself in a longer hospital stay and can be
accompanied by postoperative complications (12). Also patient characteristics
turn out to be important. The study of Hoogeboom et al. (13) showed that
patient-related characteristics can explain delayed inpatient functional
recovery after TKA. Literature shows that physical therapy has significant
positive effects on the level of physical activity within the first 3 months
after TKA (14).
Until now no risk inventory prediction model have been made for the prediction
of physical function at six weeks after TKA. Therefore we want to develop a
risk inventory prediction model. This model has an added value for clinical
practice because if we*re able to develop a well-performing prediction model,
the perioperative process of TKA patients can be improved.
Study objective
Primary Objective: To investigate if a risk model can be made, based on
physical fitness and patient characteristics, to predict the recovery of
physical function 6 weeks after total knee arthroplasty.
Secondary Objective(s): To explore if this model is able to distinguish between
low risk and high risk of a delayed recovery of physical function.
Study design
This prospective cohort study will collect data by performing preoperative
assessment of physical fitness before surgery, by all included patients. The
preoperative assessment will take place at MUMC+, Zuyderland Medical Centre and
the Annadal clinic. 6 weeks after surgery the Knee Injury and Osteoarthritis
Outcome Score (KOOS) will be conducted by phone.
Study burden and risks
During this examination, the burden on the patient is minimal. The patient will
visit the physical therapist once for the preoperative assessment. This
appointment will follow already scheduled appointments with the specialist and
will last up to 45 minutes. In addition, the subject will receive a one-time
phone call. This phone call will be a maximum of 10 minutes, for completing the
KOOS questionnaire. The preoperative assessment does not involve any risks.
P. Debeyelaan 25
Maastricht 6229HX
NL
P. Debeyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Patients will be included if:
- They are scheduled for a primary TKA
- They are able to perform the preoperative assessment
- They are able to fulfill the KOOS by phone 6 weeks postoperatively
Exclusion criteria
Patients will be excluded if:
- They get a hemi-knee or revision surgery
- They get a primary TKA not due to osteoarthritis of the knee
- They weren't able to perform the preoperative assessment
- They weren't able to fulfill the KOOS by phone 6 weeks postoperatively
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 | NL78977.068.21 |