Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

NCT ID: NCT04384809

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-05-01

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.

Conditions

Lateral Epicondylitis (Tennis Elbow)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leukocyte rich platelet rich plasma injection

Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon

Group Type: EXPERIMENTAL

Leukocyte rich platelet rich plasma

Intervention Type: BIOLOGICAL

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 tenotomy

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

Group Type: EXPERIMENTAL

Percutaneous Tenotomy

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: BIOLOGICAL

Percutaneous Tenotomy

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

STUDY20200165

Identifier Type: -

Identifier Source: org_study_id