Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in 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.

Study Overview

• Status: Withdrawn
• Conditions: Lateral Epicondylitis (Tennis Elbow)
• Intervention / Treatment: Biological: Leukocyte rich platelet rich plasma; Device: Percutaneous Tenotomy

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Leukocyte rich platelet rich plasma injection; Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon	Biological: Leukocyte rich platelet rich plasma; 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
Experimental: Percutaneous tenotomy; Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device	Device: Percutaneous Tenotomy; Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: common extensor; lateral epicondyle; tennis elbow
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Arm Injuries; Elbow Tendinopathy; Tendinopathy; Tennis Elbow
• Other Study ID Numbers: STUDY20200165

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes