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

NCT04309344 | Unknown DMC

• 1 other identifier: 831
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glenohumeral Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Improvement of range of motion (ROM)

  12 months after surgery

• Improvement of the subjective evaluation of the shoulder condition with the simple shoulder test (SST)

  12 months after surgery

• Improvement of the subjective evaluation of the shoulder condition and the pain with the Constant-Murley (CM) test

  12 months after surgery

• Improvement of the shoulder condition with the magnetic resonance imaging (MRI)

  3 months after surgery

Study Arms (2)

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

Device: WEREWOLF COBLATION System

Control

ACTIVE COMPARATOR

The mechanical shaver is used to remove superficial fibrillations.

Procedure: control

Interventions

WEREWOLF COBLATION System DEVICE

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.

RF

control PROCEDURE

mechanical debridement

Control

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

Study Officials

• Alessandro Castagna, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Castagna, MD

CONTACT

+390282244663; alessandro.castagna@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 16, 2020
• Study Start: November 19, 2019
• Primary Completion: November 30, 2020
• Study Completion: January 31, 2021
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)