Status:
UNKNOWN
Efficacy of CTM for Tennis ELbow
Lead Sponsor:
Indiana Hand to Shoulder Center
Collaborating Sponsors:
CTM Biomedical
Conditions:
Tennis Elbow
Lateral Epicondylitis \(Tennis Elbow\)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this study, the objective is to evaluate the effectiveness of a single application of human Connective Tissue Allograft (CTA) as a treatment of LET. CTM Biomedical markets and distributes decellula...
Detailed Description
Lateral Elbow Tendinopathy (LET) is considered an overload injury of the extensor tendons of the forearm where they attach at the lateral epicondyle. LET is a common condition encountered both in prim...
Eligibility Criteria
Inclusion
- Males or females age 18 or older
- Patients presenting with symptomatic lateral epicondylitis for at least 6 weeks
- Patients who have not had a meaningful symptomatic improvement after 6 weeks of physical therapy
- Patients who can consent to be a part of this study
- Patients who are able to return to the Indiana Hand to Shoulder Center or a satellite location for follow up time points
Exclusion
- Previous surgery to the lateral side of the elbow
- Systemic inflammatory conditions (RA, psoriatic arthritis, lupus, etc)
- Previous elbow injection within the last 6 months
- History of recent elbow trauma
- Patients actively involved in workman's compensation cases
- Non-English Speaking Patients
Key Trial Info
Start Date :
January 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06171555
Start Date
January 26 2023
End Date
December 31 2025
Last Update
March 27 2024
Active Locations (1)
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1
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States, 46260