Treatment of Tendinosis Using the TenJet Hydroresection System

NCT05352139 | Enrolling By Invitation FDA Device

• 1 other identifier: WIRB CMEH 01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 7

Brief Summary

Treatment of recalcitrant tendinopathy remains a clinical challenge for physicians without a minimally invasive treatment option that can consistently provide patients with a long-term relief from chronic pain and ability to return to function. Surgical debridement of degenerative tendon tissue has long been the standard of care to treat degenerative tendon pathology once all conservative or minimally invasive treatment options have failed. Ultrasound guided tenotomy is an emerging treatment option with the potential to address the underlying degenerative, diseased tissue, by selectively resecting and removing the tissue in a minimally invasive manner. Additionally, with the availability of in-office diagnostic ultrasound imaging, physicians now have an opportunity to evaluate and classify underlying tendon pathology during a clinical exam. This study is to evaluate outcomes in patients presenting with a clinical history of recalcitrant tendinopathy with confirmed diagnosis of degenerative tendinosis using diagnostic ultrasound imaging or MRI.

Conditions

Tendinopathy; Tendinosis

Outcome Measures

Primary Outcomes (7)

• Pain reduction

  Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery

  2 years

• Return to function (Elbow #1)

  This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Mayo Elbow Performance Score (MEPS)

  2 years

• Return to function (Elbow #2)

  This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Patient-Rated Tennis Elbow Evaluation (PRTEE) survey

  2 years

• Return to function (Elbow #3)

  This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Quick Disability Arm, Shoulder and Hand (QDASH) survey

  2 years

• Return to function (All cohorts)

  This will be measured in participants undergoing treatment for Elbow, Hip and Shoulder Tendinopathy using the Short Form Health Survey (SF-12) survey

  2 years

• Return to Function (Hip)

  This will be measured in participants undergoing treatment for Hip Tendinopathy using the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) survey

  2 years

• Return to Function (Shoulder)

  This will be measured in participants undergoing treatment for Shoulder Tendinopathy using the American Shoulder \& Elbow Score (ASES) survey

  2 years

Study Arms (3)

Elbow Tendinosis (Epicondylitis)

Treatment of participants who present with either lateral or medial epicondylitis

Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system; Device: Hydrocision Tenjet System

Hip Tendinosis (Gluteal Tendinopathy)

Treatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy

Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system; Device: Hydrocision Tenjet System

Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy)

Treatment of participants diagnosed with Calcific Shoulder Tendinopathy

Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system; Device: Hydrocision Tenjet System

Interventions

Resection (removal) of the degenerative tissue using the Hydrocision TenJet system PROCEDURE

During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.

Elbow Tendinosis (Epicondylitis); Hip Tendinosis (Gluteal Tendinopathy); Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy)

Hydrocision Tenjet System DEVICE

The TenJet system will be used during surgery to remove the damaged tissue from the joint

Elbow Tendinosis (Epicondylitis); Hip Tendinosis (Gluteal Tendinopathy); Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients between 18-70 years old presenting with chronic, refractory lateral and medial elbow, hip, or shoulder pain, secondary to tendinosis.

You may qualify if:

• Patient is 18 - 70 years of age
• Chronic tendon pain ≥ 3 months duration
• History and clinical examination consistent with tendinosis
• Sonographic or MRI confirmation of tendinosis
• months of conservative treatment
• Patient is willing and able to provide informed consent and comply with the study protocol

You may not qualify if:

• Full thickness tear of the tendon
• Unable to withhold anticoagulants 7 days prior to the procedure.
• Use above 81mg/day of acetylsalicyclic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
• Steroid, PRP, Stem cell or biologic injections within 3 months of the study procedure date
• Needle tenotomy, Tenex, or surgical interventions within 6 months of study procedure date
• Active local or systemic infection requiring antiviral, antibacterial or antifungal treatment
• Chronic conditions such as CRPS or fibromyalgia that might affect pain symptoms.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (7)

Standford Medicine

Redwood City, California, 94063, United States

Location

Cleveland Clinic

Coral Springs, Florida, 33067, United States

Location

Ochsner Health

Baton Rouge, Louisiana, 70836, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 28223, United States

Location

Cleveland Clinic

Lorain, Ohio, 44053, United States

Location

Penn Highlands Orthopedics and Sports Medicine

Clarion, Pennsylvania, 16214, United States

Location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 28, 2022
• Study Start: May 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

US (7)