Development of new arthroscopic evaluation method with ultra-fine needle scope

JRCT ID: jRCTs062180102

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: meniscal injury in the knee joint
• Date of first enrollment: 16/01/2017
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Patients will be admitted to the Hiroshima University hospital with general manner and anesthetized at operation room (anesthesia method will be decided by anesthesiologist). Following conventional arthroscopic examination, patients' body temperature and ECG will be monitored.
At first, under anesthesia, ultra-fine needle scope is inserted to the joint space at the sites of anteromedial and anterolateral portals without incision . According to conventional arthroscopic examination, medial and lateral menisci and other structures such as ligament and articular cartilage will be observed. All subjects are recorded as images and movies in specific hard disc drive.
Second, incisions will be place to create anteromedial and anterolatearal portals, then conventional scope will be inserted. Observation of subjects will be done with same manner. Stored images and movies in the disc drive will be kept secured place until analysis.

Outcome(s)

• Primary Outcome: Concordance rate of diagnosis of meniscus injury in the knee between ultra-fine needle and conventional scope

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Over 20 years old
2.Diagnosed as meniscus injury from preoperative X-ray, CT, and MRI images
3.Patients who is planed arthroscopic examination or treatment
4.Patients consented to being enrolled this study with specific form

Exclude criteria

1.Severe obesity (BMI > 35)
2.Patients who is diagnosed as inappropriate case by orthopaedic surgeon in charge

Related Information

• Primary Sponsor: Adachi Nobuo
• Source(s) of Monetary Support: Sumita Optical Glass, Inc.,Sumita Optical Glass, Inc.
• Secondary ID(s): UMIN000024949