Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05602701 |
| Other study ID # |
NL.78977.068.21 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 25, 2022 |
| Est. completion date |
December 1, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Maastricht University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
End-stage KOA results in limitations in activities of daily life (ADL), work and leisure.
Treatment for KOA is a stepped care process starting with a conservative approach and in
which joint replacement surgery can be considered as the last step. Total knee arthroplasty
(TKA) is regarded as the gold standard for the treatment of end-stage knee osteoarthritis
(KOA). In 2020, 19.501 TKA surgeries were performed in The Netherlands, end-stage KOA being
(97%) the most common reason for surgery.
Until now no risk inventory prediction models have been made for the prediction of physical
function at six weeks after TKA. These models may help to distinguish between having a high
risk or low risk on a delayed recovery of physical function at six weeks after TKA. This
could be beneficial for patients with a high risk. Because than the perioperative process of
this patientgroup can be optimized and improved.
Description:
Rationale: 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. Due to the increase in patients with KOA,
healthcare costs are rising. Delayed recovery also causes rising healthcare costs.
Preoperative physical fitness turned out to be a predictor of postoperative recovery. A
recently published systematic review shows effects of preoperative physical therapy up to 3
months after surgery. To provide therapy to only those who need it, physiotherapeutic care
can be optimized and healthcare costs can be saved. Therefore a prediction model, based on
physical fitness and patient characteristics, is made to predict the recovery of physical
function 6 weeks after total knee arthroplasty.
Objective: To investigate if a risk model can be made, based on physical fitness and patient
characteristics, to predict recovery of physical function 6 weeks after total knee
arthroplasty. Secondary Objective: To explore if this model is able to distinguish between
low risk and high risk of a delayed recovery of physical function.
Study design: Prospective cohort study.
Study population: The study population consists out of patients from the orthopaedic
department at the Maastricht University Medical Center + (MUMC+), Zuyderland Medical Centre
and the Annadal Clinic, with a diagnosis of end-stage KOA. All patients are scheduled for
unilateral primary TKA surgery, because of failing of conservative treatments.
Main study parameters/endpoints: 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 the
patients opinion about their knee and associated problems.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: 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.
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