Effect of Fast Inpatient Rehabilitation After TKA

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: Unknown
• Conditions: Rehabilitation; Total Knee Arthroplasty
• Intervention / Treatment: Combination product: Fast Inpatient Rehabilitation

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: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Yanyan Yang, MD; Phone Number: +86 15611963453; Email: yyykaixin@163.com
• 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: Mouwang Zhou, MM; Phone Number: 13910092892; Email: zhoumouwang@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
bilateral knee Rang Of Motion (ROM)	bilateral knee flexion and extension ROM are measured by articular protractor	1 day after TKA
bilateral quadriceps femurs	measured by manual muscle test (MMT)	1 day after TKA
hamstrings muscle strength	measured by manual muscle test (MMT)	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	1 day after TKA
modified Barthel Index (mBI)	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	the minimum is 0 and maximum 10, higher score means a worse outcome	1 day after TKA
NRS for pain		6 weeks after TKA
NRS for pain		3 months after TKA
NRS for pain		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	1 day after TKA
KOOS		6 weeks after TKA
KOOS		3 months after TKA
KOOS		6 months after TKA

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Mouwang Zhou, MM, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2019
• Primary Completion (Anticipated): September 6, 2020
• Study Completion (Anticipated): March 6, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Inpatient Rehabilitation; Fast Rehabilitation
• Other Study ID 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