Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage (Alexsen)
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|ClinicalTrials.gov Identifier: NCT04309344|
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glenohumeral Arthritis||Device: WEREWOLF COBLATION System Procedure: control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage - a Randomized Controlled Clinical Trial|
|Actual Study Start Date :||November 19, 2019|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||January 31, 2021|
The bipolar radiofrequency-based chondroplasty device is used in the COBLATION mode (yellow) with The WEREWOLF system and the wand FLOW 50 in Lo mode (low) which are approved by the FDA for chondroplasty and debridement of the articular cartilage
Device: WEREWOLF COBLATION System
The bipolar radiofrequency-based chondroplasty device is used in the COBLATION mode (yellow) with The WEREWOLF system and the wand FLOW 50 in Lo mode (low) which are approved by the FDA for chondroplasty and debridement of the articular cartilage; fibrillations were removed and the surface was smoothed. This low energy and low suction setting minimizes damage to healthy chondrocytes surrounding and is therefore the preferred setting for the removal of articular cartilage.
Active Comparator: Control
The mechanical shaver is used to remove superficial fibrillations.
- Measurement of pain reduction [ Time Frame: 12 months after surgery ]it will be assessed with numeric rating scale (NRS) questionnaire (0 no ain-10 thw worst pain).
- Improvement of range of motion (ROM) [ Time Frame: 12 months after surgery ]It will be evaluated during clinical examination using a goniometer in terms of forward flexion, abduction, external rotation with elbow at side (ER1), external rotation with elbow at 90° degree of abduction (ER2), and internal rotation (level reached from the hand on the back side)
- Improvement of the subjective evaluation of the shoulder condition with the simple shoulder test (SST) [ Time Frame: 12 months after surgery ]SST is a self-reported shoulder-specific questionnaire that measures functional limitations of the affected shoulder in patients with shoulder dysfunction. The SST consists of 12 questions with dichotomous (yes/ no) response options.
- Improvement of the subjective evaluation of the shoulder condition and the pain with the Constant-Murley (CM) test [ Time Frame: 12 months after surgery ]The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient (100 best shoulder condition-0 worst shoulder condition).
- Improvement of the shoulder condition with the magnetic resonance imaging (MRI) [ Time Frame: 3 months after surgery ]High resolution MRI will be acquired and evaluated by the radiologist
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309344
|Contact: Alessandro Castagna, MDfirstname.lastname@example.org|
|Humanitas Research Hospital||Recruiting|
|Rozzano, Milano, Italy, 20089|
|Contact: Alessandro Castagna, MD +390282244663 email@example.com|
|Principal Investigator:||Alessandro Castagna, MD||Istituto Clinico Humanitas|