Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

Phase 4

Withdrawn

• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Interventions: Biological: Leukocyte rich platelet rich plasma; Device: Percutaneous Tenotomy

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Leukocyte rich platelet rich plasma injection	Leukocyte rich platelet rich plasma	Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon
Percutaneous tenotomy	Percutaneous Tenotomy	Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device

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