Glenohumeral ArthritisAlexsenNCT04309344
Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage
A study testing WEREWOLF COBLATION System in people with Glenohumeral Arthritis, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
In the non-weight bearing glenohumeral joint, focal chondral defects are encountered infrequently and are usually found in association with other pathologies, such as glenohumeral instability, postoperative chondrolysis, focal osteonecrosis, septic arthritis, osteochondritis dissecans, and rotator cuff tears. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Glenohumeral Arthritis
- What is being tested?
- WEREWOLF COBLATION System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2019to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50-70 years.
- Arthroscopic surgery for rotator cuff disorders.
- Arthroscopic findings of ICRS grade 2 or 3 chondropathy.
- Ability to give informed consent according to the International Conference of Harmonization (ICH)-Good Clinical Practices (GCP), and national/local regulations.
Who cannot join
- Patients with a diagnosis of osteoarthritis before surgery.
- Patients with ICRS grade 4 chondropathy.
- Patients who received subacromial decompression.
- Patients who received biceps tenodesis after tenotomy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Castagna, MD, +390282244663, alessandro.castagna@humanitas.it
About this study
Official title: Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage - a Randomized Controlled Clinical Trial
In the non-weight bearing glenohumeral joint, focal chondral defects are encountered infrequently and are usually found in association with other pathologies, such as glenohumeral instability, postoperative chondrolysis, focal osteonecrosis, septic arthritis, osteochondritis dissecans, and rotator cuff tears. Several studies revealed that approximately one-third of patients with rotator cuff disease have concomitant articular cartilage lesions. Because the glenohumeral articular cartilage is one of the thinnest in the body, the overall accuracy of non-contrast MRI in detecting glenohumeral articular cartilage lesions is moderate and it is difficult to have an accurate characterization of a lesion my MRI. So, currently, arthroscopy is considered the ''gold standard'' for glenohumeral cartilage assessment. Even if the literature lacks high-quality evidence regarding the nonsurgical and surgical treatment options for patients with shoulder chondral defects, in these scenarios, where, in our experience, the most of the lesions are small, diffuse and of ICRS grade 2 or 3 (non-full thickness), arthroscopic debridement is a good option for addressing glenohumeral chondropathy. The main drawbacks with this type of procedure are the removal of underlying healthy cartilage and the potential lack of chondral surface smoothing. Alternatives used to perform arthroscopic chondral debridement is thermal application, carried out by the use of laser devices or the application of monopolar or bipolar radiofrequency (RF). As regards the glenohumeral joint, there are several studies that underlined the potential benefit of arthroscopic debridement in glenohumeral chondropathy and early stage of osteoarthritis, but the type of debridement used in all these studies was mechanical or not specified. Because recent studies showed that Compared to conventional MD, 50° RF treatment appears to be a superior method based on short- and medium-term clinical outcomes and the progression of knee osteoarthritis [11], we want to specifically evaluate the effects of RF in patients with grade II or III chondropathy found during arthroscopy for rotator cuff disorders.
Read the detailed description
This study is a prospective, therapeutic open blind randomized study. The enrollment of the patients will start immediately after the ethical committee approval. Considering our cases and our experience we plan to reach 40 patients (20 patients for group) which respect the inclusion and exclusion criteria in 2 months. We plan to enroll 6 more patients (3 for each group) in order to cover eventual loss of patients during the follow-up and these patients will be evaluated after surgery only if there will not be any losses among the initial 40 patients. During surgery, assessment of the chondropathy will be done and only patients with International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 2 or 3 chondropathy will be enrolled. After addressing the rotator cuff pathology, the patient will be randomized and the radio-frequency (RF) debridement will be performed or not performed, so the patients will enter the control group (no RF) or the treatment group. The clinical evaluation will be performed by R.R., preoperatively and at 3 months, 6 months and 12 months after surgery. At 3 months post-operatively an MRI will be obtained and assessed by an expert shoulder doctor with particular attention for the cartilage. All the data will be completed and analyzed in about 12-13 months after the enrollment is completed and we estimate to present the data by May 2020.
- Conditions
- Glenohumeral Arthritis
- Being tested
- WEREWOLF COBLATION System, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEREWOLF COBLATION SystemDevice
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.
controlProcedure or surgery
mechanical debridement
| Study group | Role | What they receive |
|---|---|---|
| RF | Experimental | 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 Receives: Device: WEREWOLF COBLATION System |
| Control | Active comparator | The mechanical shaver is used to remove superficial fibrillations. Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of pain reduction
it will be assessed with numeric rating scale (NRS) questionnaire (0 no ain-10 thw worst pain).
Measured: 12 months after surgery
Secondary outcomes (4)
Improvement of range of motion (ROM)
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)
Measured: 12 months after surgery
Improvement of the subjective evaluation of the shoulder condition with the simple shoulder test (SST)
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.
Measured: 12 months after surgery
Improvement of the subjective evaluation of the shoulder condition and the pain with the Constant-Murley (CM) test
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).
Measured: 12 months after surgery
Improvement of the shoulder condition with the magnetic resonance imaging (MRI)
High resolution MRI will be acquired and evaluated by the radiologist
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start19 Nov 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral ArthritisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor
- Investigators
- Alessandro Castagna, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309344
- Sponsor's protocol ID
- 831
- Acronym
- Alexsen
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage - a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04309344
- Acronym / sponsor ID
- Alexsen / 831
- Conditions
- Glenohumeral Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the non-weight bearing glenohumeral joint, focal chondral defects are encountered infrequently and are usually found in association with other pathologies, such as glenohumeral instability, postoperative chondrolysis, focal osteonecrosis, septic arthritis, osteochondritis dissecans, and rotator cuff tears. Several studies revealed that approximately one-third of patients with rotator cuff disease have concomitant articular cartilage lesions. Because the glenohumeral articular cartilage is one of the thinnest in the body, the overall accuracy of non-contrast MRI in detecting glenohumeral articular cartilage lesions is moderate and it is difficult to have an accurate characterization of a lesion my MRI. So, currently, arthroscopy is considered the ''gold standard'' for glenohumeral cartilage assessment. Even if the literature lacks high-quality evidence regarding the nonsurgical and surgical treatment options for patients with shoulder chondral defects, in these scenarios, where, in our experience, the most of the lesions are small, diffuse and of ICRS grade 2 or 3 (non-full thickness), arthroscopic debridement is a good option for addressing glenohumeral chondropathy. The main drawbacks with this type of procedure are the removal of underlying healthy cartilage and the potential lack of chondral surface smoothing. Alternatives used to perform arthroscopic chondral debridement is thermal application, carried out by the use of laser devices or the application of monopolar or bipolar radiofrequency (RF). As regards the glenohumeral joint, there are several studies that underlined the potential benefit of arthroscopic debridement in glenohumeral chondropathy and early stage of osteoarthritis, but the type of debridement used in all these studies was mechanical or not specified. Because recent studies showed that Compared to conventional MD, 50° RF treatment appears to be a superior method based on short- and medium-term clinical outcomes and the progression of knee osteoarthritis [11], we want to specifically evaluate the effects of RF in patients with grade II or III chondropathy found during arthroscopy for rotator cuff disorders.
Detailed description
This study is a prospective, therapeutic open blind randomized study. The enrollment of the patients will start immediately after the ethical committee approval. Considering our cases and our experience we plan to reach 40 patients (20 patients for group) which respect the inclusion and exclusion criteria in 2 months. We plan to enroll 6 more patients (3 for each group) in order to cover eventual loss of patients during the follow-up and these patients will be evaluated after surgery only if there will not be any losses among the initial 40 patients. During surgery, assessment of the chondropathy will be done and only patients with International Cartilage Regeneration and Joint Preservation Society (ICRS) grade 2 or 3 chondropathy will be enrolled. After addressing the rotator cuff pathology, the patient will be randomized and the radio-frequency (RF) debridement will be performed or not performed, so the patients will enter the control group (no RF) or the treatment group. The clinical evaluation will be performed by R.R., preoperatively and at 3 months, 6 months and 12 months after surgery. At 3 months post-operatively an MRI will be obtained and assessed by an expert shoulder doctor with particular attention for the cartilage. All the data will be completed and analyzed in about 12-13 months after the enrollment is completed and we estimate to present the data by May 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RF | Experimental | Device: WEREWOLF COBLATION SystemThe 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 |
| Control | Active comparator | Procedure: controlThe mechanical shaver is used to remove superficial fibrillations. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 50-70 years.
- Arthroscopic surgery for rotator cuff disorders.
- Arthroscopic findings of ICRS grade 2 or 3 chondropathy.
- Ability to give informed consent according to the International Conference of Harmonization (ICH)-Good Clinical Practices (GCP), and national/local regulations.
Key exclusion criteria (4 listed)
- Patients with a diagnosis of osteoarthritis before surgery.
- Patients with ICRS grade 4 chondropathy.
- Patients who received subacromial decompression.
- Patients who received biceps tenodesis after tenotomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEREWOLF COBLATION SystemThe 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. | Device | RF |
| controlmechanical debridement | Procedure or surgery | Control |
Primary outcome
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).
4 secondary outcomes
Improvement of range of motion (ROM)
Time frame: 12 months after surgery
Improvement of the subjective evaluation of the shoulder condition with the simple shoulder test (SST)
Time frame: 12 months after surgery
Improvement of the subjective evaluation of the shoulder condition and the pain with the Constant-Murley (CM) test
Time frame: 12 months after surgery
Improvement of the shoulder condition with the magnetic resonance imaging (MRI)
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Castagna, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEREWOLF COBLATION System in people with Glenohumeral Arthritis, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Castagna, MD (+390282244663, alessandro.castagna@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of pain reduction (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.