Effect of Fast Inpatient Rehabilitation After TKA

July 2, 2020 updated by: Peking University Third Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Wenjing Qi, MD
  • Phone Number: +86 15611105099
  • Email: qwj2000@126.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
bilateral knee Rang Of Motion (ROM)
Time Frame: 1 day after TKA
bilateral knee flexion and extension ROM are measured by articular protractor
1 day after TKA
bilateral quadriceps femurs
Time Frame: 1 day after TKA
measured by manual muscle test (MMT)
1 day after TKA
hamstrings muscle strength
Time Frame: 1 day after TKA
measured by manual muscle test (MMT)
1 day after TKA
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
1 day after TKA
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
1 day after TKA
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
1 day after TKA
NRS for pain
Time Frame: 6 weeks after TKA
6 weeks after TKA
NRS for pain
Time Frame: 3 months after TKA
3 months after TKA
NRS for pain
Time Frame: 6 months after TKA
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
1 day after TKA
KOOS
Time Frame: 6 weeks after TKA
6 weeks after TKA
KOOS
Time Frame: 3 months after TKA
3 months after TKA
KOOS
Time Frame: 6 months after TKA
6 months after TKA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Third Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Mouwang Zhou, MM, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M2019113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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