TendinopathyNCT05352139
Treatment of Tendinosis Using the TenJet Hydroresection System
An observational study of Tendinopathy and Tendinosis, run by Rothman Institute Orthopaedics at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tendinopathy, Tendinosis
- What is being tested?
- Resection (removal) of the degenerative tissue using the Hydrocision TenJet system and Hydrocision Tenjet System
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 600 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between 18-70 years old presenting with chronic, refractory lateral and medial elbow, hip, or shoulder pain, secondary to tendinosis.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Ochsner Health
Baton Rouge, Louisiana, 70836
University of North Carolina
Chapel Hill, North Carolina, 28223
Penn Highlands Orthopedics and Sports Medicine
Clarion, Pennsylvania, 16214
Cleveland Clinic
Coral Springs, Florida, 33067
Cleveland Clinic
Lorain, Ohio, 44053
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Standford Medicine
Redwood City, California, 94063
About this study
Official title: Prospective Multi-Center Patient Registry for Patients With Elbow, Hip, and Calcific Shoulder Tendinosis Treated Utilizing the TenJet Hydroresection System
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
- Being tested
- Resection (removal) of the degenerative tissue using the Hydrocision TenJet system, Hydrocision Tenjet System
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection (removal) of the degenerative tissue using the Hydrocision TenJet systemProcedure or surgery
During the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers.
Hydrocision Tenjet SystemDevice
The TenJet system will be used during surgery to remove the damaged tissue from the joint
| Study group | Role | What they receive |
|---|---|---|
| Elbow Tendinosis (Epicondylitis) | Treatment of participants who present with either lateral or medial epicondylitis Receives: 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 Receives: 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 Receives: Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system; Device: Hydrocision Tenjet System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 May 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352139
- Sponsor's protocol ID
- WIRB CMEH 01
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Patient Registry for Patients With Elbow, Hip, and Calcific Shoulder Tendinosis Treated Utilizing the TenJet Hydroresection System
- ClinicalTrials.gov ID
- NCT05352139
- Acronym / sponsor ID
- WIRB CMEH 01
- Conditions
- Tendinopathy, Tendinosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elbow Tendinosis (Epicondylitis) | – | Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system, Device: Hydrocision Tenjet SystemTreatment of participants who present with either lateral or medial epicondylitis |
| Hip Tendinosis (Gluteal Tendinopathy) | – | Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system, Device: Hydrocision Tenjet SystemTreatment of participants diagnosed with Recalcitrant Gluteal Tendinopathy |
| Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy) | – | Procedure: Resection (removal) of the degenerative tissue using the Hydrocision TenJet system, Device: Hydrocision Tenjet SystemTreatment of participants diagnosed with Calcific Shoulder Tendinopathy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 18-70 years old presenting with chronic, refractory lateral and medial elbow, hip, or shoulder pain, secondary to tendinosis.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection (removal) of the degenerative tissue using the Hydrocision TenJet systemDuring the procedure, the TenJet device will remove degenerative tendinopathic tissue using pressurized saline without causing harm to the healthy tendon fibers. | Procedure or surgery | Elbow Tendinosis (Epicondylitis), Hip Tendinosis (Gluteal Tendinopathy), Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy) |
| Hydrocision Tenjet SystemThe TenJet system will be used during surgery to remove the damaged tissue from the joint | Device | Elbow Tendinosis (Epicondylitis), Hip Tendinosis (Gluteal Tendinopathy), Shoulder Calcific Tendinosis (Calcific Shoulder Tendinopathy) |
Primary outcome
Pain reduction
Time frame: 2 years
Using the Visual Analog Scale for Pain (VAS) participants will be asked to report their pain score after surgery
Return to function (Elbow #1)
Time frame: 2 years
This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Mayo Elbow Performance Score (MEPS)
Return to function (Elbow #2)
Time frame: 2 years
This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Patient-Rated Tennis Elbow Evaluation (PRTEE) survey
Return to function (Elbow #3)
Time frame: 2 years
This will be measured in participants undergoing treatment for Elbow Tendinopathy using the Quick Disability Arm, Shoulder and Hand (QDASH) survey
Return to function (All cohorts)
Time frame: 2 years
This will be measured in participants undergoing treatment for Elbow, Hip and Shoulder Tendinopathy using the Short Form Health Survey (SF-12) survey
Return to Function (Hip)
Time frame: 2 years
This will be measured in participants undergoing treatment for Hip Tendinopathy using the Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) survey
Return to Function (Shoulder)
Time frame: 2 years
This will be measured in participants undergoing treatment for Shoulder Tendinopathy using the American Shoulder \& Elbow Score (ASES) survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Related trials for Tendinopathy
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Synovial Tissue as a Biomarker in the Management of Pigmented Villonodular Synovitis
Synovitis Villonodular
Enrolling by invitation
High and Low Level Laser Therapy in De Quervain's Tenosynovitis
DeQuervain Tendinopathy
Recruiting
High-intensity Laser Therapy Versus Extracorporeal Shock Wave on Tendon Thickness and Occupation Ratio In Patients With Chronic Supraspinatus Tendinopathy
Supraspinatus Tendinopathy
Recruiting
Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tendinopathy and Tendinosis, run by Rothman Institute Orthopaedics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.