Effect of Fast Inpatient Rehabilitation After TKA

• Conditions: Total Knee Arthroplasty; Rehabilitation
• Interventions: Combination Product: Fast Inpatient Rehabilitation

• Registration Number: NCT04458480
• Lead Sponsor: Peking University Third Hospital

Brief 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.

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 Timeline

• Study Start: 2019-09-07
• Study First Submitted: 2020-06-26
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2020-09-06
• Study Completion: 2021-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed Group	Fast Inpatient Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
bilateral knee Rang Of Motion (ROM)	1 day after TKA	bilateral knee flexion and extension ROM are measured by articular protractor
Numerical Rating Scale (NRS) for pain	1 day after TKA	the minimum is 0 and maximum 10, higher score means a worse outcome
NRS for pain	6 months after TKA
bilateral quadriceps femurs	1 day after TKA	measured by manual muscle test (MMT)
hamstrings muscle strength	1 day after TKA	measured by manual muscle test (MMT)
Hospital for Special Surgery-Knee Rating scale (HSSKR)	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)	1 day after TKA	to measure ADL, with the minimum 0 and maximum 100, higher score means a better outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)	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	6 months after TKA

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China