Total Knee ArthroplastyNCT04458480
Effect of Fast Inpatient Rehabilitation After TKA
An observational study of Total Knee Arthroplasty and Rehabilitation, run by Peking University Third Hospital at 1 site in China.
Trial summary
Rehabilitation is an important part of the post-operative treatment after TKA by consensus. This study intends to analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty, Rehabilitation
- What is being tested?
- Fast Inpatient Rehabilitation
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2019to 6 Mar 2021
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: He/She is admitted to orthopedics department of Peking University Third Hospital and undertaken initial unilateral TKA due to osteoarthritis, rheumatoid arthritis, etc.
Who may be able to join
- Initial unilateral TKA patients due to osteoarthritis, rheumatoid arthritis, etc.
- Satisfactory operative knee joint ROM: knee flexion ≥120° and extension ≥ 0°.
- Prior informed consent by patients.
Who cannot join
- Complication of other medical conditions and disability to cooperate with rehabilitation.
- Complication of other conditions affecting bilateral lower limbs such as fracture, tumor, neurologic disorder, etc.
- Deep venous thrombosis of lower limbs with exception of inter-muscular venous thrombosis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Mouwang Zhou, MM, 13910092892, zhoumouwang@163.com
About this study
Official title: Effect of Fast Inpatient Rehabilitation After Total Knee Arthroplasty
Rehabilitation is an important part of the post-operative treatment after TKA by consensus. This study intends to analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA.
Read the detailed description
Rehabilitation, which is an important part of the post-operative treatment after TKA, could effectively alleviate symptoms of pain and swell, as well as improve knee joint and general function. It has reached a consensus that post-TKA rehabilitation should contain muscle strengthening, ROM, proprioceptive, balance training and physical factor therapy, etc. This study intends to use observational cohort study methods with exposure factor of fast inpatient rehabilitation after TKA, establish a TKA exposure group and a control group of TKA without inpatient rehabilitation, analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA.
- Conditions
- Total Knee Arthroplasty, Rehabilitation
- Being tested
- Fast Inpatient Rehabilitation
- Keywords
- Fast Rehabilitation, Inpatient Rehabilitation, Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast Inpatient RehabilitationCombination product
Routine inpatient rehabilitation protocol, administered by licensed Physical Therapist, duration period of 1.5h-2h each time, 2 times for weekdays and 1 time for weekends, totally lasting for 1 week, are applied to the exposed group. After the fast inpatient rehabilitation for 1 week, the patients can get discharged if reaching to the rehabilitation goals of symptoms of pain and swell reduced, knee flexion ≥ 90° and knee extension ≥ 0°, quadriceps femurs and hamstrings muscle strength enhanced, recovery to aided standing and walking, and acquiring of rehabilitation training methods.
| Study group | Role | What they receive |
|---|---|---|
| Exposed Group | Both exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge. Receives: Combination Product: Fast Inpatient Rehabilitation | |
| Control Group | Both exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
bilateral knee Rang Of Motion (ROM)
bilateral knee flexion and extension ROM are measured by articular protractor
Measured: 1 day after TKA
bilateral quadriceps femurs
measured by manual muscle test (MMT)
Measured: 1 day after TKA
hamstrings muscle strength
measured by manual muscle test (MMT)
Measured: 1 day after TKA
Hospital for Special Surgery-Knee Rating scale (HSSKR)
to measure knee function, with the minimum 0 and maximum 100, higher score means a better outcome
Measured: 1 day after TKA
modified Barthel Index (mBI)
to measure ADL, with the minimum 0 and maximum 100, higher score means a better outcome
Measured: 1 day after TKA
Numerical Rating Scale (NRS) for pain
the minimum is 0 and maximum 10, higher score means a worse outcome
Measured: 1 day after TKA
NRS for pain
Measured: 6 weeks after TKA
NRS for pain
Measured: 3 months after TKA
NRS for pain
Measured: 6 months after TKA
Knee Injury and Osteoarthritis Outcome Score (KOOS)
to measure knee function and global function, with the minimum 0 and maximum 100, higher score means a better outcome
Measured: 1 day after TKA
KOOS
Measured: 6 weeks after TKA
KOOS
Measured: 3 months after TKA
KOOS
Measured: 6 months after TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start7 Sep 2019
- Primary completion6 Sep 2020 (estimated)
- Study completion6 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouwang Zhou, MM, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458480
- Sponsor's protocol ID
- M2019113
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fast Inpatient Rehabilitation After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04458480
- Acronym / sponsor ID
- M2019113
- Conditions
- Total Knee Arthroplasty, Rehabilitation
- Keywords
- Fast Rehabilitation, Inpatient Rehabilitation, Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 6 Sep 2020 (estimated)
- Study completion
- 6 Mar 2021 (estimated)
- First posted
- 7 Jul 2020 (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.
Rehabilitation is an important part of the post-operative treatment after TKA by consensus. This study intends to analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA.
Detailed description
Rehabilitation, which is an important part of the post-operative treatment after TKA, could effectively alleviate symptoms of pain and swell, as well as improve knee joint and general function. It has reached a consensus that post-TKA rehabilitation should contain muscle strengthening, ROM, proprioceptive, balance training and physical factor therapy, etc. This study intends to use observational cohort study methods with exposure factor of fast inpatient rehabilitation after TKA, establish a TKA exposure group and a control group of TKA without inpatient rehabilitation, analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Group | – | Combination Product: Fast Inpatient RehabilitationBoth exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge. |
| Control Group | – | –Both exposed group and control group are undertaken TKA surgery and routine postoperative management for 2 days in orthopedics department. Exposed group patients are transferred from orthopedics department to rehabilitation department on 2nd day after TKA, and accept fast inpatient rehabilitation for 1 week before hospital discharge, while control group patients continue to accept routine peri-operative management and conventional oral instructions of exercises in orthopedics department until hospital discharge. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- He/She is admitted to orthopedics department of Peking University Third Hospital and undertaken initial unilateral TKA due to osteoarthritis, rheumatoid arthritis, etc.
Key inclusion criteria (3 listed)
- Initial unilateral TKA patients due to osteoarthritis, rheumatoid arthritis, etc.
- Satisfactory operative knee joint ROM: knee flexion ≥120° and extension ≥ 0°.
- Prior informed consent by patients.
Key exclusion criteria (3 listed)
- Complication of other medical conditions and disability to cooperate with rehabilitation.
- Complication of other conditions affecting bilateral lower limbs such as fracture, tumor, neurologic disorder, etc.
- Deep venous thrombosis of lower limbs with exception of inter-muscular venous thrombosis.
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 |
|---|---|---|
| Fast Inpatient RehabilitationRoutine inpatient rehabilitation protocol, administered by licensed Physical Therapist, duration period of 1.5h-2h each time, 2 times for weekdays and 1 time for weekends, totally lasting for 1 week, are applied to the exposed group. After the fast inpatient rehabilitation for 1 week, the patients can get discharged if reaching to the rehabilitation goals of symptoms of pain and swell reduced, knee flexion ≥ 90° and knee extension ≥ 0°, quadriceps femurs and hamstrings muscle strength enhanced, recovery to aided standing and walking, and acquiring of rehabilitation training methods. | Combination product | Exposed Group |
Primary outcome
bilateral knee Rang Of Motion (ROM)
Time frame: 1 day after TKA
bilateral knee flexion and extension ROM are measured by articular protractor
bilateral quadriceps femurs
Time frame: 1 day after TKA
measured by manual muscle test (MMT)
hamstrings muscle strength
Time frame: 1 day after TKA
measured by manual muscle test (MMT)
Hospital for Special Surgery-Knee Rating scale (HSSKR)
Time frame: 1 day after TKA
to measure knee function, with the minimum 0 and maximum 100, higher score means a better outcome
modified Barthel Index (mBI)
Time frame: 1 day after TKA
to measure ADL, with the minimum 0 and maximum 100, higher score means a better outcome
Numerical Rating Scale (NRS) for pain
Time frame: 1 day after TKA
the minimum is 0 and maximum 10, higher score means a worse outcome
NRS for pain
Time frame: 6 weeks after TKA
NRS for pain
Time frame: 3 months after TKA
NRS for pain
Time frame: 6 months after TKA
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 1 day after TKA
to measure knee function and global function, with the minimum 0 and maximum 100, higher score means a better outcome
KOOS
Time frame: 6 weeks after TKA
KOOS
Time frame: 3 months after TKA
KOOS
Time frame: 6 months after TKA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: Yes
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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.
Mouwang Zhou, MM study chair
Peking University Third Hospital
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 Total Knee Arthroplasty and Rehabilitation, 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 3 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 7 Jul 2020. 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?
Contact Yanyan Yang, MD (+86 15611963453, yyykaixin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bilateral knee Rang Of Motion (ROM) (time frame: 1 day after TKA). The study lists 13 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 7 Jul 2020.