CClinicalTrials.gg
Status unknownNCT04458480Updated Jul 7, 2020

Effect of Fast Inpatient Rehabilitation After TKA

An observational study in Total Knee Arthroplasty and Rehabilitation, sponsored by Peking University Third Hospital. Status unknown at 1 site in China. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-07.

Sponsored by Peking University Third Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
50 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Total Knee Arthroplasty
  • Rehabilitation

Keywords

  • Fast Rehabilitation
  • Inpatient Rehabilitation
  • Total Knee Arthroplasty
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

Interventions

  • Combination productFast Inpatient Rehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. bilateral knee Rang Of Motion (ROM)

    bilateral knee flexion and extension ROM are measured by articular protractor

    Time frame: 1 day after TKA

  2. bilateral quadriceps femurs

    measured by manual muscle test (MMT)

    Time frame: 1 day after TKA

  3. hamstrings muscle strength

    measured by manual muscle test (MMT)

    Time frame: 1 day after TKA

  4. 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

    Time frame: 1 day after TKA

  5. modified Barthel Index (mBI)

    to measure ADL, with the minimum 0 and maximum 100, higher score means a better outcome

    Time frame: 1 day after TKA

  6. Numerical Rating Scale (NRS) for pain

    the minimum is 0 and maximum 10, higher score means a worse outcome

    Time frame: 1 day after TKA

  7. NRS for pain

    Time frame: 6 weeks after TKA

  8. NRS for pain

    Time frame: 3 months after TKA

  9. NRS for pain

    Time frame: 6 months after TKA

  10. 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

    Time frame: 1 day after TKA

  11. KOOS

    Time frame: 6 weeks after TKA

  12. KOOS

    Time frame: 3 months after TKA

  13. KOOS

    Time frame: 6 months after TKA

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, Beijing 100191, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04458480
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
Sep 7, 2019
Primary completion
Sep 6, 2020 (estimated)
Completion
Mar 6, 2021 (estimated)
Last update
Jul 7, 2020

Study contacts

Yanyan Yang, MD
Contact
yyykaixin@163.com
+86 15611963453
Wenjing Qi, MD
Contact
qwj2000@126.com
+86 15611105099
Mouwang Zhou, MM
study chair · Peking University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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