Rehabilitation；Arthroplasty, Replacement, KneeNCT05404568
The Hierarchical Rehabilitation After Total Knee Arthroplasty
An observational study of Rehabilitation；Arthroplasty, Replacement, Knee, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation；Arthroplasty, Replacement, Knee
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with knee osteoarthritis who will take total knee arthroplasty
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100089
Boyang Yu, M.D., +8601082266771, accept@pku.edu.cn
About this study
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.
Read more
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.
- Being tested
- Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
We included patients with knee osteoarthritis who planned to take total knee arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of patients of total knee arthroplasty
Satisfaction of patients（1-10 scoring）
Measured: 12 months after Total Knee Arthroplasty
HSS-KS score
Hospital For Special Surgery Knee Score
Measured: 12 months after Total Knee Arthroplasty
Secondary outcomes (7)
Visual analog scale of patients
Visual analog scale of patients
Measured: 3 weeks，3 and 12 months after Total Knee Arthroplasty
Range of motion
Range of motion of undergoing surgery
Measured: 3 weeks，3 and 12 months after Total Knee Arthroplasty
10mWT
10 meters working test
Measured: 3 weeks，3 and 12 months after Total Knee Arthroplasty
WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 3 weeks，3 and 12 months after Total Knee Arthroplasty
SF-36
36-Item Short Form Survey
Measured: 3 weeks，3 and 12 months after Total Knee Arthroplasty
Satisfaction of patients of total knee arthroplasty
Satisfaction of patients（1-10 scoring）
Measured: 3 weeks，3 months after Total Knee Arthroplasty
HSS-KS score
Hospital For Special Surgery Knee Score
Measured: 3 weeks，3 months after Total Knee Arthroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 May 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation；Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404568
- Sponsor's protocol ID
- M2022120
- Status last verified
- Apr 2022
- First submitted
- 31 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hierarchical Rehabilitation After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05404568
- Acronym / sponsor ID
- M2022120
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with knee osteoarthritis who will take total knee arthroplasty
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyWe included patients with knee osteoarthritis who planned to take total knee arthroplasty | Procedure or surgery | – |
Primary outcome
Satisfaction of patients of total knee arthroplasty
Time frame: 12 months after Total Knee Arthroplasty
Satisfaction of patients（1-10 scoring）
HSS-KS score
Time frame: 12 months after Total Knee Arthroplasty
Hospital For Special Surgery Knee Score
7 secondary outcomes
Visual analog scale of patients
Time frame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
Range of motion
Time frame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
10mWT
Time frame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
WOMAC
Time frame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
SF-36
Time frame: 3 weeks，3 and 12 months after Total Knee Arthroplasty
Satisfaction of patients of total knee arthroplasty
Time frame: 3 weeks，3 months after Total Knee Arthroplasty
HSS-KS score
Time frame: 3 weeks，3 months after Total Knee Arthroplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation；Arthroplasty, Replacement, Knee, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of patients of total knee arthroplasty (time frame: 12 months after Total Knee Arthroplasty). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.