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To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
This is a prospective, non-randomized, single arm post-marketing clinical study of patients undergoing percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System to treat elbow tendinosis. Patients will be followed for a maximum of 12 months post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TenJet System | Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TenJet System | Device | Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Elbow Pain Using Visual Analog Scale (VAS) | Change in elbow pain (VAS) compared with baseline. VAS range 0 (no pain) to 10 (intolerable pain); higher scores indicate worse pain. Mean change is calculated as baseline minus follow-up, so positive values indicate improvement. Time points: 2 weeks, 6 weeks, 3 months, 6 months, 12 months. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE) | Change in total PREE score compared with baseline on a 0-100 scale (lower scores indicate less pain/higher function). Mean change is calculated as baseline minus follow-up (positive = improvement) and reported at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Up to 12 months |
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Inclusion Criteria:
Patient is > 18 years of age
Chronic lateral or medial elbow pain > 3 month duration
History and clinical examination consistent with lateral or medial epicondylitis
Sonographic evidence of medial or lateral elbow tendinosis as evidenced by
> 3 months of non-operative treatment that included
Patient is willing and able to provide informed consent and comply with the study protocol
Exclusion Criteria:
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Patients with chronic, refractory lateral or medial elbow pain secondary to elbow tendinosis
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| Name | Affiliation | Role |
|---|---|---|
| Reginald Kapteyn, DO | Orthopaedic Associates of Muskegon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Associates of Muskegon | Muskegon | Michigan | 49444 | United States | ||
| Penn Highlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | TenJet System | Percutaneous ultrasound guided medial and lateral tenotomy in the elbow using the TenJet HydroSurgery System TenJet System: Percutaneous ultrasound guided medial and lateral tenotomy in the elbow using the TenJet HydroSurgery System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline includes 29 participants contributing 32 elbows. Baseline measures are reported at the elbow level where indicated.
| ID | Title | Description |
|---|---|---|
| BG000 | TenJet System | Percutaneous ultrasound guided medial and lateral tenotomy in the elbow using the TenJet HydroSurgery System TenJet System: Percutaneous ultrasound guided medial and lateral tenotomy in the elbow using the TenJet HydroSurgery System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Elbow Pain Using Visual Analog Scale (VAS) | Change in elbow pain (VAS) compared with baseline. VAS range 0 (no pain) to 10 (intolerable pain); higher scores indicate worse pain. Mean change is calculated as baseline minus follow-up, so positive values indicate improvement. Time points: 2 weeks, 6 weeks, 3 months, 6 months, 12 months. | Baseline includes 29 participants contributing 32 elbows; follow-up is analyzed per elbow. At the 12-month timepoint, 27 elbows (25 participants) completed follow-up, as reported in the Participant Flow. However, VAS outcome data were available for 26 elbows. One elbow did not have a recorded VAS score at 12 months due to a missing patient-reported outcome. Therefore, analyses of VAS at 12 months are based on the 26 elbows with available data. | Posted | Mean | Standard Deviation | VAS Score | Up to 12 months | elbows | elbows |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TenJet System | Percutaneous ultrasound guided medial and lateral tenotomy in the elbow using the TenJet HydroSurgery System TenJet System: Percutaneous ultrasound guided medial and lateral tenotomy in the elbow using the TenJet HydroSurgery System |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suneela Frary | HydroCision | 978-289-1311 | sfrary@hydrocision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Mar 18, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| DuBois |
| Pennsylvania |
| 15801 |
| United States |
| Noble Pain Management & Sports Medicine | Fort Worth | Texas | 76110 | United States |
| elbows |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
| Height (cm) | Mean | Full Range | centimeters | Participants |
|
|
| Weight (kg) | Mean | Full Range | kilograms | Participants |
|
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| Mean Duration of Symptoms | Mean | Full Range | months | Participants |
|
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| Elbow Tendinosis Diagnosis (medial / lateral / both) | Number | elbows | elbows |
|
|
| Mean BMI | Mean | Full Range | kg/m^2 | Participants |
|
|
Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System
TenJet System: Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System
| OG001 | 2 Weeks | Participants follow-up at 2 Weeks |
| OG002 | 6 Weeks | Participant follow-up at 6 Weeks |
| OG003 | 3 Months | Participant follow-up at 3 Months |
| OG004 | 6 Months | Patient follow-up at 6 Months |
| OG005 | 12 Months | Participant follow-up at 12 Months |
|
|
| Secondary | Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE) | Change in total PREE score compared with baseline on a 0-100 scale (lower scores indicate less pain/higher function). Mean change is calculated as baseline minus follow-up (positive = improvement) and reported at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. | Baseline includes 29 participants contributing 32 elbows; follow-up is analyzed per elbow. At the 12-month timepoint, 27 elbows (25 participants) completed follow-up. Outcome data are reported based on available data at each timepoint. Where applicable, differences between the number of elbows followed and analyzed reflect missing patient-reported outcomes rather than loss to follow-up. | Posted | Mean | Standard Deviation | PREE Score | Up to 12 months | elbows | elbows |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 2 |
| 29 |
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| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
|
| elbows |
|
|
| Mean improvement over baseline |
|
|