A Study to Evaluate the Safety of Ultrasound-guided Tenotomy for Achilles Tendinopathy and Feasibility of a Standardized Ultrasound Imaging Protocol
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 20-005052
Sponsor Protocol Number: AMSSM R34 Bridge
About this study
The purpose of this study is to determine the safety of Ultrasound-guided Tenotomy (USGT) by describing the rate and types of USGT-related complications at the Achilles, and to demonstrate the feasibility of an RCT (randomized control trial) at each site by measuring the patient volume per year treated with USGT for Achilles Tendinopathy (AT), and capture rate utilizing a standardized ultrasound imaging protocol for AT.
The research is about the post-procedure outcomes and is not about the ultrasound device or the ultrasound-guided tenotomy procedure.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients ≥ 18 years old.
- All patients indicated for Ultrasound-guided Tenotomy (USGT) for chronic Achilles Tendinopathy (AT) pain (> 3 months).
Exclusion Criteria:
- < 18 years old.
- Cannot read/write in English.
- Having USGT concurrent with other procedures (e.g., PRP or platelet-rich plasma).
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jacob Sellon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available