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Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy

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ClinicalTrials.gov Identifier: NCT04384809
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Robert Flannery, MD, 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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis (Tennis Elbow) Biological: Leukocyte rich platelet rich plasma Device: Percutaneous Tenotomy Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-blinded, parallel randomized control trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in the Treatment of Chronic Common Extensor Tendinopathy
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in pain: visual analogue scale [ Time Frame: 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.

  2. Change in function [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384809


Contacts
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Contact: Robert Flannery, MD 216-844-3078 Robert.Flannery@UHhospitals.org

Sponsors and Collaborators
University Hospitals Cleveland Medical Center
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Responsible Party: Robert Flannery, MD, Principal Investigator, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT04384809    
Other Study ID Numbers: STUDY20200165
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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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
Keywords provided by Robert Flannery, MD, University Hospitals Cleveland Medical Center:
common extensor
lateral epicondyle
tennis elbow
Additional relevant MeSH terms:
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Tendinopathy
Tennis Elbow
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Elbow Tendinopathy
Arm Injuries