Status:
ENROLLING_BY_INVITATION
Treatment of Tendinosis Using the TenJet Hydroresection System
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Tendinopathy
Tendinosis
Eligibility:
All Genders
18-70 years
Brief Summary
Treatment of recalcitrant tendinopathy remains a clinical challenge for physicians without a minimally invasive treatment option that can consistently provide patients with a long-term relief from chr...
Eligibility Criteria
Inclusion
- Patient is 18 - 70 years of age
- Chronic tendon pain ≥ 3 months duration
- History and clinical examination consistent with tendinosis
- Sonographic or MRI confirmation of tendinosis
- 3 months of conservative treatment
- Patient is willing and able to provide informed consent and comply with the study protocol
Exclusion
- Full thickness tear of the tendon
- Unable to withhold anticoagulants 7 days prior to the procedure.
- Use above 81mg/day of acetylsalicyclic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 7 days of treatment
- Steroid, PRP, Stem cell or biologic injections within 3 months of the study procedure date
- Needle tenotomy, Tenex, or surgical interventions within 6 months of study procedure date
- Active local or systemic infection requiring antiviral, antibacterial or antifungal treatment
- Chronic conditions such as CRPS or fibromyalgia that might affect pain symptoms.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05352139
Start Date
May 1 2022
End Date
April 30 2025
Last Update
June 21 2024
Active Locations (7)
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1
Standford Medicine
Redwood City, California, United States, 94063
2
Cleveland Clinic
Coral Springs, Florida, United States, 33067
3
Ochsner Health
Baton Rouge, Louisiana, United States, 70836
4
University of North Carolina
Chapel Hill, North Carolina, United States, 28223