Effect of Fast Inpatient Rehabilitation After TKA

Rehabilitation Clinical Trial

Official title:

Effect of Fast Inpatient Rehabilitation After Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458480
• Other study ID #: M2019113
• Status: Recruiting
• Start date: September 7, 2019
• Est. completion date: March 6, 2021

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: Yanyan Yang, MD
• Phone: +86 15611963453
• Email: yyykaixin[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 6, 2021
• Est. primary completion date: September 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rehabilitation
• Total Knee Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bilateral knee Rang Of Motion (ROM)	bilateral knee flexion and extension ROM are measured by articular protractor	1 day after TKA
Primary	bilateral quadriceps femurs	measured by manual muscle test (MMT)	1 day after TKA
Primary	hamstrings muscle strength	measured by manual muscle test (MMT)	1 day after TKA
Primary	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
Primary	modified Barthel Index (mBI)	to measure ADL, with the minimum 0 and maximum 100, higher score means a better outcome	1 day after TKA
Primary	Numerical Rating Scale (NRS) for pain	the minimum is 0 and maximum 10, higher score means a worse outcome	1 day after TKA
Primary	NRS for pain		6 weeks after TKA
Primary	NRS for pain		3 months after TKA
Primary	NRS for pain		6 months after TKA
Primary	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
Primary	KOOS		6 weeks after TKA
Primary	KOOS		3 months after TKA
Primary	KOOS		6 months after TKA