Elbow, Tennis
Conditions
Brief summary
To evaluate the acute and long-term clinical outcomes of tenotomy with the TenJet System in patients with elbow tendinosis.
Detailed description
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.
Interventions
DEVICETenJet System
Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System
Sponsors
HydroCision, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * tendon thickening and hypoechogenicity, * with or without hypervascularity on Doppler examination and, * with or without cortical irregularities, Or MRI findings consistent with lateral or medial tendinosis, with or without intrasubstance tear. * \> 3 months of non-operative treatment that included * nonsteroidal anti-inflammatory drugs * activity modification * physical therapy * elbow straps * With or without previous steroid injections, protein rich plasma injections, or stem cell injections * Patient is willing and able to provide informed consent and comply with the study protocol
Exclusion criteria
* Documented ipsilateral upper extremity musculoskeletal condition (other than elbow tendinosis in the same arm on the opposite side) * Bleeding disorders and/or current use of anti-coagulants with the inability to withhold anticoagulants for required time prior to procedure * Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment * Steroid injection within 4 weeks of the study procedure * Active local or systemic infection * Patient found to have further degenerative changes of the elbow contributing to pain, such as cartilage thinning, loose body, or evidence of tendinosis other than medial or lateral, including triceps or ulnar collateral ligament. * Patient is known or suspected to be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Elbow Pain Using Visual Analog Scale (VAS) | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Elbow Function Using the Patient-Rated Elbow Evaluation Questionnaire (PREE) | Up to 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORReginald Kapteyn, DO
Orthopaedic Associates of Muskegon
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.0 years |
| Elbow Tendinosis Diagnosis (medial / lateral / both) Both | 2 elbows |
| Elbow Tendinosis Diagnosis (medial / lateral / both) Lateral location | 26 elbows |
| Elbow Tendinosis Diagnosis (medial / lateral / both) Medial location | 4 elbows |
| Height (cm) | 158.75 centimeters |
| Mean BMI | 29.8 kg/m^2 |
| Mean Duration of Symptoms | 27.0 months |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 10 Participants |
| Weight (kg) | 83.73 kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 2 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
None listed