Safety and efficacy of the sj-HAL on early recovery of knee extension after surgery in patients with osteoarthritis of the knee

JRCT ID: jRCTs032180111

Registered date:08/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: osteoarthritis of the knee
• Date of first enrollment: 16/04/2015
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Knee extension exercise using knee wearable robot

Outcome(s)

• Primary Outcome: Adverse event, device trouble, feasibility of study
• Secondary Outcome: Extension lag, knee range of motion, knee muscle power

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

Patients who underwent TKA / UKA and HTO on Knee OA at our hospital orthopedic surgeon, patients who are hospitalized after surgery
1. Patients can agree by written paper, and patients have enough consent capability
2. Patients admitted to our hospital orthopedic surgery
3. Patients whose automatic maximum knee extension angle of the operative knee joint did not reach the maximal knee extension angle measured by anesthesia at the end of surgery on 5-7 days after surgery
4. Patients who underwent surgery on only one side
5. Patients who weigh 40-100 kg, height 150-190 cm and are able to wear HAL. However, even if the height is out of the range, if the body size matches, the patient can be worn
6. During the study period, patients who can continue hospitalization according to the study schedule and are observable throughout the entire study period

Exclude criteria

Patients who conflict with one of the following criteria are excluded and are not subject to this clinical study
1. Patients whose deformities of the skeletal system such as osteoarthritis, degenerative spondylosis, scoliosis and the like other than the surgical site are high, and it is judged that it is difficult to carry out exercise including articulation or attachment of HAL
2. Patients who are considered difficult to wear and train HAL due to underlying disease or perioperative complications
3. Patients with bleeding tendency or complications such as osteoporosis which are problematic in training
4. Patients who can not affix HAL biomedical electrodes due to skin diseases etc.
5. Patients who participated in other studies etc. within 12 weeks of the start of this clinical study
6. Patients who have judged that participation in this study is inappropriate by clinical trial responsible doctor or clinical trial sharing doctor

Related Information

• Primary Sponsor: Yamazaki Masashi