Biological Effects of a Bipolar Radiofrequency-based Device Over Shoulder Cartilage (Alexsen)

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.

Study Overview

• Status: Unknown
• Conditions: Glenohumeral Arthritis
• Intervention / Treatment: Device: WEREWOLF COBLATION System; Procedure: control

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Humanitas Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 50-70 years.
2. Arthroscopic surgery for rotator cuff disorders.
3. Arthroscopic findings of ICRS grade 2 or 3 chondropathy.
4. Ability to give informed consent according to the International Conference of Harmonization (ICH)-Good Clinical Practices (GCP), and national/local regulations.

Exclusion Criteria:

1. Patients with a diagnosis of osteoarthritis before surgery.
2. Patients with ICRS grade 4 chondropathy.
3. Patients who received subacromial decompression.
4. Patients who received biceps tenodesis after tenotomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RF; 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.	Procedure: control; mechanical debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of pain reduction	it will be assessed with numeric rating scale (NRS) questionnaire (0 no ain-10 thw worst pain).	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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).	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	3 months after surgery

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Collaborators: Smith & Nephew, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: March 10, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: 831

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No