HMB on muscle function in OA with THA or TKA

JRCT ID: jRCTs051200094

Registered date:11/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: osteoarthritis
• Date of first enrollment: 23/12/2020
• Target sample size: 80
• Study type: Interventional
• Intervention(s): make a comparison between preoperative and postoperative muscle function in osteoarthritic patients with total hip or knee arthroplasty who receive postoperative rehaviritation and HMB administration

Outcome(s)

Primary Outcome

TKA: difference in knee extensor strength between the baseline and 3 months postoperatively
THA: difference in hip abductor strength between the baseline and 3 months postoperatively

Secondary Outcome

Main secondary outcomes:
TKA: difference in hip abductor and hip extensor strength between the baseline and 3 months postoperatively
THA: difference in hip extensor and knee extensor strength between the baseline and 3 months postoperatively
All subjects: A comparison of muscle strength alterations during the first 3 months after total hip or knee arthroplasty between patients with and without preoperative sarcopenia

Other secondary outcomes in each subject:
Muscle strength, 10 m walking speed, Timed Up and Go test, grip strength, muscle volume, muscle composition,Alterations in the ratio of patients with sarcopenia between the base line and 3 months postoperativ

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1)Patients with osteoarthritis who undergo total hip or knee arthroplasty
2)Patients who will be able to receive standard postoperative rehabilitation
3)Patients who will be able to receive regular follow-up
4)Female patients at age 65 and more at the time of consent acquisition
5)Patients who have voluntarily consented to participate in this study with their comprehension on thorough explanation of this study

Exclude criteria

1)Patients who had taken HMB before consent acquisition
2)Patients who had taken medicine or supplement that may affect muscle function
3) Patients who are not expected to receive the standard recovery rehabilitation at the recovery phase hospital after transfer from our hospital
4)Patients with radiotherapy or chemotherapy, or with treatment with steroid or immunosuppressive drugs
5)Patients with paresis
6)Patients with history of malignancy within the last 5 years
7)Patients with history of unstable angina, cardiac infarction, brain infarction, cerebral hemorrhage, or transient cerebral ischemic attack within the last 6 months
8)Patients with severe diseases in liver, kidney, heart, lung, blood, or endocrine and metabolic systems
9)Patients with or with history of inflammatory joint diseases except osteoarthritis
10)Patients with history of total hip or knee arthroplasty within the last 6 months
11)Patients under consideration of other surgical treatment during the protocol period of this study
12)Patients participating in other interventional or clinical trial
13)Patients who are considered inappropriate as the subjects for this study by the principal investigator or co-investigators

Related Information

• Primary Sponsor: yasuda tadashi