Clinical study of ESWT after meniscus repair

Phase 1

• Conditions: Meniscal longitudinal tear

• Registration Number: JPRN-jRCTs032210145
• Lead Sponsor: Chikuda Hirotaka

Brief Summary

This study was terminated with no participants because it was difficult to reach required number in the registration period.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-11
• Study Completion: 2022-01-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1) Patients over 16 years old
2) Patients diagnosed with meniscal longitudinal tear by MRI
3) Patients with knee pain above NRS2
4) Patients with PS between 0 and 1
5) Patients who hoped to undergo arthroscopic meniscus repair
6) Patients obtained from consent documents

Exclusion Criteria

1) Patients who previously underwent therapy for their diseased knee using ESWT
2) Patients with knee osteoarthritis of G3 or higher according to the Kellgren-Lawrence classification
3) Patients with complication of cruciate ligament tear or fracture around knee
4) Patients with previous history of meniscus resection, meniscus repair, cruciate ligament reconstruction or open reduction and internal fixation of bone around knee
5) Patients diagnosed with cognitive decline at the physician's discretion
6) Patients with cotraindication of MRI
7) Patients with open epiphyseal line
8) Patients with untreated blood coagulation disorders such as hemophilia or patients taking anticoagulants
9) Patients with thrombosis
10) Patients with malignant tumor
11) Pregnant woman
12) Patients who have received steroid treatment for 6 months or more, or within 6 weeks after steroid injection
13) Patients judged inappropriate by the doctor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing rate on MRI

Secondary Outcome Measures

Name	Time	Method
RS <br>Clinical score (KOOS, IKDC score, Lysholme score) <br>Scientific findings (Ballottement of patella, Range of motion, Mcmurray test, Watson-Johns test, Lachman test, Posterior drawer test) <br>MRI T2 mapping<br>Adverse event <br>Daily use of oral analgesics