Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

NCT04384809 | Withdrawn Phase 4 FDA Drug FDA Device

• 1 other identifier: STUDY20200165
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis (Tennis Elbow)

Keywords

common extensor; lateral epicondyle; tennis elbow

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Leukocyte rich platelet rich plasma injection

EXPERIMENTAL

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

Biological: Leukocyte rich platelet rich plasma

Percutaneous tenotomy

EXPERIMENTAL

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

Device: Percutaneous Tenotomy

Interventions

Leukocyte rich platelet rich plasma 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

Leukocyte rich platelet rich plasma injection

Percutaneous Tenotomy DEVICE

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

Percutaneous tenotomy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded, parallel randomized control trial

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: January 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

US (1)