Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

Phase 4

Withdrawn

• Conditions: Lateral Epicondylitis (Tennis Elbow)

• Registration Number: NCT04384809
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21
• Study Start: 2023-01-01
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in function	up to 12 months post-procedure	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
Change in pain: visual analogue scale	up to 12 months post-procedure	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.

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States