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

Phase 1

• Conditions: osteoarthritis of the knee

• Registration Number: JPRN-jRCTs032180111
• Lead Sponsor: Yamazaki Masashi

Brief Summary

Robotic knee extension training using HAL was implemented in OA knee patients with TKA/UKA and HTO. No serious adverse events were observed during the Robotic knee extension training using HAL, and that training with HAL could be performed safely and effectively. Overall, our results suggest that Robotic knee extension training using HAL has the potential to improve knee pain, range of active knee extension, power of knee extension in OA knee patients with TKA/UKA and HTO.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-08
• Study Completion: 2020-11-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified