Back to resultsPlatelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy
Primary Purpose
Lateral Epicondylitis (Tennis Elbow)
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Leukocyte rich platelet rich plasma
Percutaneous Tenotomy
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis (Tennis Elbow) focused on measuring common extensor, lateral epicondyle, tennis elbow
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
Sites / Locations
- University Hospitals Cleveland Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Leukocyte rich platelet rich plasma injection
Percutaneous tenotomy
Arm Description
Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon
Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04384809
First Posted
May 7, 2020
Last Updated
November 16, 2022
Sponsor
University Hospitals Cleveland Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04384809
Brief Title
Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy
Official Title
Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in the Treatment of Chronic Common Extensor Tendinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis (Tennis Elbow)
Keywords
common extensor, lateral epicondyle, tennis elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Non-blinded, parallel randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Leukocyte rich platelet rich plasma injection
Arm Type
Experimental
Arm Description
Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon
Arm Title
Percutaneous tenotomy
Arm Type
Experimental
Arm Description
Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device
Intervention Type
Biological
Intervention Name(s)
Leukocyte rich platelet rich plasma
Intervention Description
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
Device
Intervention Name(s)
Percutaneous Tenotomy
Intervention Description
Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device
Primary Outcome Measure Information:
Title
Change in pain: visual analogue scale
Description
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.
Time Frame
up to 12 months post-procedure
Title
Change in function
Description
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
Time Frame
up to 12 months post-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy
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