Coblation Debridement for Rotator Cuff Repair

(FLOW90 Trial)

Overseen By Kristie More, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Previous surgery, Labral repair, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day (surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to repair damaged rotator cuffs, tendons in the shoulder that aid in arm movement and lifting. One method uses coblation debridement (FLOW90), which involves a special tool to clean the tendon, while the other employs a traditional mechanical method. The trial aims to determine which method more effectively reduces pain and improves shoulder function. It may suit individuals with a full-thickness rotator cuff tear who experience persistent shoulder pain and have not found relief from treatments like physical therapy or steroid injections for over three months. As an unphased trial, this study provides an opportunity to explore innovative treatments that could potentially enhance shoulder health.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have failed conservative treatments like physical therapy, steroid injections, or anti-inflammatory medications for more than 3 months, which suggests you may continue these treatments.

What prior data suggests that coblation debridement is safe for rotator cuff repair?

Research has shown that coblation debridement, such as the FLOW90 Wand, gently removes tissue using a plasma field. This method uses less heat, protecting nearby areas from damage. Studies have found that this approach can lead to quicker recovery and better long-term outcomes for patients.

A few reports have noted issues, such as the wand activating on its own during a procedure. While this might sound concerning, these reports are rare. The device is already used in many surgeries, indicating it is generally well-accepted.

Safety in treatments often improves with ongoing research and technology updates. This information provides reassurance about the safety of the coblation method for human use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about coblation debridement using FLOW90 for rotator cuff repair because it offers a unique approach compared to standard mechanical debridement. Unlike traditional methods that manually scrape away damaged tissue, coblation uses a controlled plasma field to precisely remove tissue with minimal damage to surrounding healthy areas. This technique may reduce recovery time and improve healing outcomes, making it a promising option for patients with rotator cuff injuries.

What evidence suggests that coblation debridement is effective for rotator cuff repair?

Research has shown that using the FLOW 90 wand for coblation debridement, one of the treatments in this trial, benefits rotator cuff repair. Studies indicate that the FLOW 90 wand operates faster than other tools in similar surgeries, removing damaged tissue more quickly and efficiently. The device uses radiofrequency energy to cut and remove tissue while reducing bleeding. These features suggest that coblation debridement could effectively treat rotator cuff injuries by providing quicker and potentially cleaner tissue removal. Meanwhile, another arm of this trial evaluates the effectiveness of standard mechanical debridement for comparison. ^{1 6 7 8 9}

Who Is on the Research Team?

Ian Lo, MD FRSCS

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a repairable full-thickness rotator cuff tear smaller than 5cm, who have tried other treatments like physical therapy or steroid injections without success. They must be able to get an MRI and commit to follow-up visits. People with partial tears, irreparable tears, high operative risks, severe fatty atrophy of the muscle, or those involved in litigation or compensation cases cannot join.

Inclusion Criteria

The subject has signed the REB approved informed consent form (ICF) specific to this study prior to enrollment

I have had pain and disability for over 3 months despite trying treatments like physical therapy.

I can move on my own and can attend all required follow-up visits.

Exclusion Criteria

I need surgery to fix a tear in the cartilage of my hip.

I have had surgery to repair the rotator cuff in my shoulder.

I have a shoulder injury that cannot be fixed with surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical repair of the rotator cuff with either coblation or mechanical debridement

1 day (surgery)

1 visit (in-person)

Post-operative Rehabilitation

Standard post-operative rehab program for all patients

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 3, 6, 12, and 24 months post-operatively

24 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Coblation Debridement (FLOW90)

Trial Overview The study is testing two methods of preparing the bone before repairing a torn rotator cuff: coblation debridement (using FLOW90) versus mechanical debridement. Participants will be randomly assigned to one of these treatment groups in this controlled trial.

How Is the Trial Designed?

Group I: Coblation Debridement Experimental Treatment 1 Intervention

FLOW 90 / WEREWOLF debridement of rotator cuff footprint.

Group II: Mechanical Debridement Active Control 1 Intervention

Standard mechanical debridement of rotator cuff footprint.

Coblation Debridement (FLOW90) is already approved in United States for the following indications:

Approved in United States as WEREWOLF FLOW 90 COBLATION WAND for:

• Ablation/Debridement of soft tissues and hemostasis of blood vessels in arthroscopic and orthopedic procedures

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Published Research Related to This Trial

A study involving 35 patients with spinal disc herniations showed that percutaneous disc nucleoplasty using coblation resulted in significant immediate pain relief and improved patient satisfaction compared to a non-operated group.

After 3 months and 1 year, 84% and 93% of patients reported good results, indicating that coblation is an effective and modern treatment option for various types and sizes of disc protrusions in the lumbar spine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Coblation of nucleus pulposus in treatment of military men's lumbar disc protrusions]. Manukovskiĭ, VA., Badalov, VI., Tiulikov, KV., et al.[2012]

In a study of 47 patients with discogenic back pain, the Nucleoplasty procedure demonstrated significant pain relief, with 80% of patients reporting at least 50% pain reduction one month after treatment, although this percentage decreased over time to 53% at 12 months.

The Nucleoplasty procedure was found to be safe, with no complications reported, and it is considered a minimally invasive technique that effectively improves functional abilities such as sitting, standing, and walking in a substantial number of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of percutaneous disc decompression using coblation in managing chronic discogenic low back pain: a prospective, observational study. Singh, V., Piryani, C., Liao, K.[2006]

In a study of 90 patients with sciatica due to lumbar disc herniation, those treated with plasma disc decompression (PDD) experienced significantly greater reductions in leg pain and improved quality of life compared to those receiving fluoroscopy-guided transforaminal epidural steroid injections (TFESI).

Over a 2-year follow-up, 56% of patients in the PDD group remained free from needing further procedures, compared to only 28% in the TFESI group, indicating that PDD may be a more effective long-term treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial. Gerszten, PC., Smuck, M., Rathmell, JP., et al.[2022]

Coblation debridement technology uses a focused plasma field to effectively remove unwanted tissues from wounds, offering a safer alternative for patients who may not tolerate traditional surgical debridement due to age or health conditions.

This method minimizes thermal damage to surrounding tissues by keeping local temperatures below 50°C, which helps prevent wound bed renecrosis while still achieving effective tissue dissolution.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coblation technology for surgical wound debridement: principle, experimental data, and technical data. Trial, C., Brancati, A., Marnet, O., et al.[2015]

Coblation significantly reduced bacterial load in wounds compared to other methods, making it an effective option for wound debridement.

Unlike hydrodebridement (Versajet), which caused significant bacterial aerosolization, Coblation and curette debridement did not spread bacteria into the air, highlighting Coblation's safety in preventing bacterial transmission during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacteria aerosol spread and wound bacteria reduction with different methods for wound debridement in an animal model. Sönnergren, HH., Polesie, S., Strömbeck, L., et al.[2015]

In a study involving 58 patients, percutaneous low-power laser discectomy (PLLD) showed a higher rate of clinical improvement at 6 and 12 months post-surgery (92.9%) compared to low-temperature plasma radiofrequency ablation (coblation) (70.0%).

PLLD also significantly reduced the disk herniation index, indicating better radiological outcomes, while coblation did not show changes in disk degeneration, suggesting that PLLD may be more effective for long-term recovery in cervical radiculopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Radiological Comparisons of Percutaneous Low-Power Laser Discectomy and Low-Temperature Plasma Radiofrequency Ablation for Cervical Radiculopathy: A Prospective, Multicenter, Cohort Study. Lan, X., Wang, Z., Huang, Y., et al.[2022]

In a study of 16 patients with early postoperative infections following extremity fractures, Coblation debridement effectively treated the infections while retaining internal fixation, leading to complete wound healing without recurrence.

All patients healed successfully within an average of 4.8 months, avoiding complications like nonunion or osteomyelitis, demonstrating that Coblation debridement is a safe and effective method for managing infections in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of plasma-mediated bipolar radiofrequency ablation debridement in treatment with retention of internal fixation for early postoperative infection of fractures of extremities]. Lu, Y., Yang, R., Zhu, J., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2212628725000878

Arthroscopic Biologic Shoulder Tuberoplasty Irreparable ... After this, the exposed rotator cuff footprint on the tuberosity is debrided using a combination of a coblation wand (FLOW 90; Smith & Nephew), shaver, and burr ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10698133/

Radiofrequency in arthroscopic shoulder surgery Radiofrequency is currently utilized in impingement syndrome, fracture fixation, instability, nerve injury, adhesive capsulitis, postoperative stiffness, and ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/K183346.pdf

January 24, 2019 ArthroCare Corporation Ms. Shruthi Bhat ... The FLOW 90 Wand (Wand) is a bipolar, RF electrosurgical device designed for resection, ablation, and coagulation of soft tissue, and hemostasis ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05084781

Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone ... Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair. Detailed Description. Prospective, Double blind, ...

5. smith-nephew.com smith-nephew.com/en-us/health-care-professionals/products/sports-medicine/werewolf-flow-90-wand

WEREWOLF FLOW 90 COBLATION Wand Shown to have a significantly faster ablation rate than other frequently used 90-degree arthroscopy wands.***6. The FLOW 90 Wand features an innovative tip ...

6. withpower.com withpower.com/trial/phase-rotator-cuff-injuries-6-2020-09ba6

Coblation Debridement for Rotator Cuff Repair (FLOW90 Trial) Coblation Debridement (FLOW90) is unique because it uses a plasma field to remove unwanted tissue with minimal heat, reducing the risk of damaging surrounding ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K210423.pdf

K210423.pdf - accessdata.fda.gov The WEREWOLF+ COBLATION System utilizes bipolar technology specifically designed for the resection, ablation, and coagulation of tissues and ...

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=20153330&pc=GEI

MAUDE Adverse Event Report: ARTHROCARE ... It was reported that during an arthroscopy procedure, the ablate or coagulate function of the werewolf 90 wand was activated even though no hand button or ...

9. prnewswire.com prnewswire.com/news-releases/smith--nephew-launches-new-flow-90-wand-at-isakos-joining-its-innovative-collection-of-coblation-technology-and-shoulder-repair-portfolios-300848596.html

Smith & Nephew launches new FLOW 90™ Wand at ... Smith & Nephew's patented COBLATION technology has been shown to deliver faster patient recovery3 and better long-term patient outcomes1,2 ...