BACKGROUND: The optimal choice for intervention for recalcitrant lateral elbow tendinopathy remains unclear as various treatment modalities have documented comparable results in the literature. PURPOSE: To explore the safety, tolerability, and early efficacy of a new minimally invasive mode of treatment that delivers focused, calibrated ultrasonic energy, effectively microresecting the pathological tendon and removing only pathological tissue. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Seven male and 13 female patients aged 33 to 65 years averaging 12.5 months (range, 4-48) of failed nonoperative therapy underwent the ultrasonic microresection procedure in an outpatient clinic setting. The procedure involved a sterile, ultrasound-guided percutaneous microresection with a proprietary device (TX1) performed through a stab incision under local anesthesia. The duration of the procedure and complications of the device or procedure were assessed. Outcome parameters included patient satisfaction; visual analog scale (VAS) pain scores; Disabilities of the Arm, Shoulder and Hand (DASH) scores at 1, 3, 6, and 12 months; and ultrasound assessment at 3 and 6 months. RESULTS: The median duration for the sterile confirmatory ultrasound examination (phase 1) was 88.5 seconds (range, 39-211; SD, ±47.6), the median duration of the procedure proper (phase 2) was 10.1 minutes (range, 4.1-19.4; SD, ±3.7), and the median energy time (duration the TX1 device was activated) was 32.5 seconds (range, 18-58; SD, ±11.0). No complications were encountered. A significant improvement in VAS score (from 5.5 to 3.3; P < .001) occurred by 1 week, and significant improvements in both DASH-Compulsory (from 21.7 to 11.3; P = .001) and DASH-Work (from 25.0 to 6.3; P = .012) scores occurred by 1 month. The VAS scores further improved at 3, 6, and 12 months (from 2.0 to 1.0 to 0.50; P = .003 and .023). The DASH-Compulsory score improved significantly from 3 to 6 months (from 8.6 to 4.6; P = .003), and both the DASH-Compulsory and DASH-Work scores were sustained by 12 months. Sonographically reduced tendon thickness (19 patients), resolved or reduced hypervascularity (17 patients), and reduced hypoechoic area (18 patients) occurred by 6 months. Nineteen of the 20 patients (95%) expressed satisfaction with the procedure, with 9 patients being very satisfied with their overall experience at 6 months after the procedure, 10 patients somewhat satisfied, and 1 patient neutral. CONCLUSION: Ultrasonic microresection of diseased tissue with the TX1 device provides a focally directed, safe, specific, minimally invasive, and well-tolerated treatment for recalcitrant lateral elbow tendinopathy in an office-based or ambulatory surgical setting with good evidence of some level of efficacy in 19 of 20 patients (95%) that is sustained for at least 1 year.
BACKGROUND: The optimal choice for intervention for recalcitrant lateral elbow tendinopathy remains unclear as various treatment modalities have documented comparable results in the literature. PURPOSE: To explore the safety, tolerability, and early efficacy of a new minimally invasive mode of treatment that delivers focused, calibrated ultrasonic energy, effectively microresecting the pathological tendon and removing only pathological tissue. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: Seven male and 13 female patients aged 33 to 65 years averaging 12.5 months (range, 4-48) of failed nonoperative therapy underwent the ultrasonic microresection procedure in an outpatient clinic setting. The procedure involved a sterile, ultrasound-guided percutaneous microresection with a proprietary device (TX1) performed through a stab incision under local anesthesia. The duration of the procedure and complications of the device or procedure were assessed. Outcome parameters included patient satisfaction; visual analog scale (VAS) pain scores; Disabilities of the Arm, Shoulder and Hand (DASH) scores at 1, 3, 6, and 12 months; and ultrasound assessment at 3 and 6 months. RESULTS: The median duration for the sterile confirmatory ultrasound examination (phase 1) was 88.5 seconds (range, 39-211; SD, ±47.6), the median duration of the procedure proper (phase 2) was 10.1 minutes (range, 4.1-19.4; SD, ±3.7), and the median energy time (duration the TX1 device was activated) was 32.5 seconds (range, 18-58; SD, ±11.0). No complications were encountered. A significant improvement in VAS score (from 5.5 to 3.3; P < .001) occurred by 1 week, and significant improvements in both DASH-Compulsory (from 21.7 to 11.3; P = .001) and DASH-Work (from 25.0 to 6.3; P = .012) scores occurred by 1 month. The VAS scores further improved at 3, 6, and 12 months (from 2.0 to 1.0 to 0.50; P = .003 and .023). The DASH-Compulsory score improved significantly from 3 to 6 months (from 8.6 to 4.6; P = .003), and both the DASH-Compulsory and DASH-Work scores were sustained by 12 months. Sonographically reduced tendon thickness (19 patients), resolved or reduced hypervascularity (17 patients), and reduced hypoechoic area (18 patients) occurred by 6 months. Nineteen of the 20 patients (95%) expressed satisfaction with the procedure, with 9 patients being very satisfied with their overall experience at 6 months after the procedure, 10 patients somewhat satisfied, and 1 patient neutral. CONCLUSION: Ultrasonic microresection of diseased tissue with the TX1 device provides a focally directed, safe, specific, minimally invasive, and well-tolerated treatment for recalcitrant lateral elbow tendinopathy in an office-based or ambulatory surgical setting with good evidence of some level of efficacy in 19 of 20 patients (95%) that is sustained for at least 1 year.
Authors: Sravya Vajapey; Sennay Ghenbot; Michael R Baria; Robert A Magnussen; W Kelton Vasileff Journal: Sports Health Date: 2020-11-30 Impact factor: 3.843