Clinical trial NCT05404568: The Hierarchical Rehabilitation After Total Knee Arthroplasty
Official title: The Hierarchical Rehabilitation After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rehabilitation；Arthroplasty, Replacement, Knee
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with knee osteoarthritis who will take total knee arthroplasty

Brief summary: Knee osteoarthritis (KOA) is one of the diseases that seriously affect the quality of human life, resulting in a significant disease burden. Total knee arthroplasty (TKA) is one of the ultimate treatments for knee osteoarthritis. Functional recovery after total knee arthroplasty depends on rehabilitation. With the incidence rate of knee osteoarthritis increasing, the amount of knee replacement surgery is increasing rapidly, the demand for medical resources and medical expenditure has increased.

At present, there are many rehabilitation pathways after total knee arthroplasty, but there is no unified evidence-based medicine guide to guide postoperative rehabilitation. The current early rehabilitation pathways after total knee arthroplasty in China can be generally divided into three categories: inpatient rehabilitation, outpatient rehabilitation and home-based self-rehabilitation. The intensity and expenditure of rehabilitation treatment decrease in turn.

Individual differences among patients lead to different rehabilitation treatment needs for functional recovery. How to predict the rehabilitation needs of patients after total knee arthroplasty and choose an appropriate rehabilitation pathway based on themselves need to be solved.

We expected to establish a prediction model that we will be able to inform patients with knee osteoarthritis who just taken total knee arthroplasty and want to choose a pathway to rehabilitation by using the baseline status, that will help them to choose their best pathway to rehabilitation -- provide rehabilitation according to needs, save costs and improve the quality of life.


Eligibility criteria: Inclusion Criteria:

* ① Knee osteoarthritis was diagnosed and total knee arthroplasty was planned;
* ② Good cognitive function, can cooperate and understand the contents of this test, and is willing to cooperate with rehabilitation evaluation and postoperative follow-up during perioperative period;
* ③ Aged 18 and above, voluntarily participated in the study and signed informed consent.

Exclusion Criteria:

* ① Accompanied by other local or systemic diseases that seriously affect the function of lower limbs, such as severe lumbar spinal stenosis, severe rheumatoid arthritis, etc;
* ② Patients have consciousness disorders, cognitive disorders, serious mental disorders and other diseases that affect limb function and cognition.

Primary outcomes:
measure: Satisfaction of patients of total knee arthroplasty
timeFrame: 12 months after Total Knee Arthroplasty
measure: HSS-KS score
timeFrame: 12 months after Total Knee Arthroplasty
Secondary outcomes:
measure: Visual analog scale of patients
timeFrame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
measure: Range of motion
timeFrame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
measure: 10mWT
timeFrame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
measure: WOMAC
timeFrame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
measure: SF-36
timeFrame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
measure: Satisfaction of patients of total knee arthroplasty
timeFrame: 3 weeks，3 months after Total Knee Arthroplasty
measure: HSS-KS score
timeFrame: 3 weeks，3 months after Total Knee Arthroplasty
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: