Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

University Hospitals Cleveland Medical Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Lateral Epicondylitis (Tennis Elbow)

Interventions

Leukocyte rich platelet rich plasmaBIOLOGICAL

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

Percutaneous TenotomyDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: up to 12 months post-procedure

Data from ClinicalTrials.gov

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