Clinical trial NCT05352139: Treatment of Tendinosis Using the TenJet Hydroresection System
Official title: Prospective Multi-Center Patient Registry for Patients With Elbow, Hip, and Calcific Shoulder Tendinosis Treated Utilizing the TenJet Hydroresection System
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Tendinopathy
Tendinosis
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain reduction
timeFrame: 2 years
measure: Return to function (Elbow #1)
timeFrame: 2 years
measure: Return to function (Elbow #2)
timeFrame: 2 years
measure: Return to function (Elbow #3)
timeFrame: 2 years
measure: Return to function (All cohorts)
timeFrame: 2 years
measure: Return to Function (Hip)
timeFrame: 2 years
measure: Return to Function (Shoulder)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Standford Medicine
state: California
city: Coral Springs
country: United States
facility: Cleveland Clinic
state: Florida
city: Baton Rouge
country: United States
facility: Ochsner Health
state: Louisiana
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Lorain
country: United States
facility: Cleveland Clinic
state: Ohio
city: Clarion
country: United States
facility: Penn Highlands Orthopedics and Sports Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: