Status:
COMPLETED
Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Chronic Tendinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a person's ability to perform daily activities and recreation. Traditional conservative treatments include acti...
Eligibility Criteria
Inclusion
- aged 18-100 years
- pain (≥ 5/10 pain on the VAS) that is a direct result of tendinosis as determined by history of injury and study team member physician's best judgment and review of medical records, imaging studies, etc.
- Tendinosis will be confirmed by clinical and ultrasonographic examination by the PI
- ≥3 months of pain after injury that has failed conservative treatments or after corticosteroid (CSI) (must be 3 months after CSI to avoid theoretical tendon rupture)
Exclusion
- taking coumadin or other anti-coagulant or anti-platelet medication
- known coagulopathy or bleeding dyscrasia
- current or recent fluoroquinolone prescription
- prior PNT or PRP for the affected tendon(s)
- known systemic illness such as vasculitis, an autoimmune or an inflammatory disease, or uncontrolled diabetes
- presence of other musculoskeletal injury or tendon rupture in the region
- currently are or plan to become pregnant during the study.
- Patients taking aspirin or NSAIDs are not excluded.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01833598
Start Date
September 1 2012
End Date
June 1 2019
Last Update
December 23 2020
Active Locations (2)
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1
Hospital for Special Surgery
New York, New York, United States, 10021
2
Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029