Trial Outcomes & Findings for Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System (NCT NCT03487250)
NCT ID: NCT03487250
Last Updated: 2026-05-07
Results Overview
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.
COMPLETED
29 participants
Up to 12 months
2026-05-07
Participant Flow
Unit of analysis: elbows
Participant milestones
| Measure |
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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Overall Study
STARTED
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29 32
|
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Overall Study
COMPLETED
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25 27
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Overall Study
NOT COMPLETED
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4 5
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Lost to follow-up, withdrawn, or pursuing surgical intervention
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4
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Baseline Characteristics
Percutaneous US Guided Elbow Tenotomy With the TenJet HydroSurgery System
Baseline characteristics by cohort
| Measure |
TenJet System
n=32 elbows
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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Age, Continuous
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48.0 years
n=29 Participants
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Sex: Female, Male
Female
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19 Participants
n=29 Participants
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Sex: Female, Male
Male
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10 Participants
n=29 Participants
|
|
Region of Enrollment
United States
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29 participants
n=29 Participants
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Height (cm)
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158.75 centimeters
n=29 Participants
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Weight (kg)
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83.73 kilograms
n=29 Participants
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Mean Duration of Symptoms
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27.0 months
n=29 Participants
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Elbow Tendinosis Diagnosis (medial / lateral / both)
Medial location
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4 elbows
n=32 elbows
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Elbow Tendinosis Diagnosis (medial / lateral / both)
Lateral location
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26 elbows
n=32 elbows
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Elbow Tendinosis Diagnosis (medial / lateral / both)
Both
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2 elbows
n=32 elbows
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Mean BMI
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29.8 kg/m^2
n=29 Participants
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PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Baseline
n=32 elbows
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
|
2 Weeks
n=29 elbows
Participants follow-up at 2 Weeks
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6 Weeks
n=28 elbows
Participant follow-up at 6 Weeks
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3 Months
n=26 elbows
Participant follow-up at 3 Months
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6 Months
n=26 elbows
Patient follow-up at 6 Months
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12 Months
n=26 elbows
Participant follow-up at 12 Months
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|---|---|---|---|---|---|---|
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Change in Elbow Pain Using Visual Analog Scale (VAS)
VAS Score
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5.1 VAS Score
Standard Deviation 2.5
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3.0 VAS Score
Standard Deviation 1.7
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1.9 VAS Score
Standard Deviation 1.7
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1.1 VAS Score
Standard Deviation 1.2
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0.7 VAS Score
Standard Deviation 1.0
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0.5 VAS Score
Standard Deviation 0.9
|
|
Change in Elbow Pain Using Visual Analog Scale (VAS)
Mean improvement over baseline
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—
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2.2 VAS Score
Standard Deviation 2.3
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3.0 VAS Score
Standard Deviation 2.4
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3.9 VAS Score
Standard Deviation 2.7
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4.3 VAS Score
Standard Deviation 2.8
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4.4 VAS Score
Standard Deviation 3.0
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SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Baseline
n=32 elbows
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
|
2 Weeks
n=31 elbows
Participants follow-up at 2 Weeks
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6 Weeks
n=28 elbows
Participant follow-up at 6 Weeks
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3 Months
n=26 elbows
Participant follow-up at 3 Months
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6 Months
n=28 elbows
Patient follow-up at 6 Months
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12 Months
n=27 elbows
Participant follow-up at 12 Months
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|---|---|---|---|---|---|---|
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Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE)
PREE Total Score
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58.5 PREE Score
Standard Deviation 17.6
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37.9 PREE Score
Standard Deviation 19.7
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25.2 PREE Score
Standard Deviation 17.0
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18.1 PREE Score
Standard Deviation 15.7
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14.0 PREE Score
Standard Deviation 11.1
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9.6 PREE Score
Standard Deviation 12.3
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Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE)
Mean improvement over baseline
|
—
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20.6 PREE Score
Standard Deviation 15.4
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31.2 PREE Score
Standard Deviation 16.9
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40.2 PREE Score
Standard Deviation 20.6
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46.4 PREE Score
Standard Deviation 20.7
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47.3 PREE Score
Standard Deviation 20.3
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Adverse Events
TenJet System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TenJet System
n=29 participants at risk
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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Musculoskeletal and connective tissue disorders
Worsening Pain
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6.9%
2/29 • Number of events 2 • 12 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place