Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05352139
Other study ID # WIRB CMEH 01
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date April 30, 2025

Study information

Verified date June 2024
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 600
Est. completion date April 30, 2025
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 - 3 months of conservative treatment - Patient is willing and able to provide informed consent and comply with the study protocol Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Resection (removal) of the degenerative tissue using the Hydrocision TenJet system
During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.
Device:
Hydrocision Tenjet System
The TenJet system will be used during surgery to remove the damaged tissue from the joint

Locations

Country Name City State
United States Ochsner Health Baton Rouge Louisiana
United States University of North Carolina Chapel Hill North Carolina
United States Penn Highlands Orthopedics and Sports Medicine Clarion Pennsylvania
United States Cleveland Clinic Coral Springs Florida
United States Cleveland Clinic Lorain Ohio
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania
United States Standford Medicine Redwood City California

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain reduction Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery 2 years
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT03307499 - NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery N/A
Completed NCT02499484 - Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy N/A
Completed NCT01944150 - Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis N/A
Recruiting NCT04578418 - Effect of Collagen Supplementation on Tendinopathy N/A
Completed NCT03262181 - The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy N/A
Completed NCT03502434 - A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers Phase 1
Recruiting NCT04278833 - Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions Phase 4
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Recruiting NCT05603468 - Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair Phase 4
Terminated NCT01544244 - The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis N/A
Recruiting NCT04144946 - Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
Terminated NCT02978833 - Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy Phase 4
Completed NCT03229291 - A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects Phase 1
Recruiting NCT06056440 - Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab) N/A
Recruiting NCT04058509 - Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain N/A
Withdrawn NCT02981394 - Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
Active, not recruiting NCT02600910 - Natural History of Shoulder Pathology in Manual Wheelchair Users
Completed NCT04793971 - Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
Not yet recruiting NCT01225497 - Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy N/A