NCT04384809

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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)

Interventions

Type	Name	Description
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
DEVICE	Percutaneous Tenotomy	Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2020-05-12
• Last updated: 2022-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study