Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in the Treatment of Chronic Common Extensor Tendinopathy

Conditions
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Lateral Epicondylitis (Tennis Elbow)

Intervention / Treatment
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* Biological: Leukocyte rich platelet rich plasma
* Device: Percutaneous Tenotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-blinded, parallel randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Leukocyte rich platelet rich plasma injection<br>Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon | Biological: Leukocyte rich platelet rich plasma<br>* Leukocyte rich platelet rich plasma will be obtained and prepared from a peripheral artery of the subject and then will be injected in the common extensor tendon<br>|
| Experimental: Percutaneous tenotomy<br>Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device | Device: Percutaneous Tenotomy<br>* Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain: visual analogue scale | Change in pain will be measured using a 10 point visual analogue scale where 0 represents no pain and 10 indicates the worst pain possible. | up to 12 months post-procedure | 
| Change in function | Change in function will be measured using the Oxford Elbow score using a 48 point scale where a score of 0 indicates severe functional impairment and a score of 48 indicates no functional impairment | up to 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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common extensor, lateral epicondyle, tennis elbow