Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

University Hospitals (UH)

Status and phase: Withdrawn; Phase 4

Conditions: Lateral Epicondylitis (Tennis Elbow)

Treatments: Device: Percutaneous Tenotomy; Biological: Leukocyte rich platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04384809

STUDY20200165

Details and patient eligibility

About

This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.

Full description

This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy. Patients with a history of common extensor tendinopathy for greater than 3 months, refractory to conservative treatments, are randomized into one of two groups: injection with leukocyte rich platelet rich plasma or percutaneous tenotomy with the Tenex system. Both groups of patients are followed up in clinic at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following the procedure to examine levels of pain or complications following both procedures.

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 3 months of lateral elbow pain
• Subjectively failed trial of physical therapy and counterbracing
• Identifiable pathology on ultrasound (one or more of the following: thickened or disorganized tendon origin, microtearing, edema, neovascularization

Exclusion criteria

• Steroid injection within the last 3 months
• Previous surgery for common extensor tendinopathy
• Current treatment with analgesics
• Pregnant, non-English speaking, or illiterate individuals
• History of anemia
• History of bleeding disorder
• Anticoagulant use
• History of cervical radiculopathy
• Hemoglobin less than 11 grams per deciliter
• Hematocrit less than 33%
• Platelet count outside of normal range of 150-400 x 1000 microliter

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Leukocyte rich platelet rich plasma injection

Experimental group

Description:

Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon

Treatment:

Biological: Leukocyte rich platelet rich plasma

Percutaneous tenotomy

Experimental group

Description:

Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device

Treatment:

Device: Percutaneous Tenotomy