Lateral Epicondylitis (Tennis Elbow)Phase 4NCT04384809
Platelet Rich Plasma Injection vs Percutaneous Tenotomy for Common Extensor Tendinopathy
A Phase 4 study testing Leukocyte rich platelet rich plasma and Percutaneous Tenotomy in people with Lateral Epicondylitis (Tennis Elbow), run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Leukocyte rich platelet rich plasma and Percutaneous Tenotomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in the Treatment of Chronic Common Extensor Tendinopathy
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.
Read the 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)
- Being tested
- Leukocyte rich platelet rich plasma, Percutaneous Tenotomy
- Keywords
- common extensor, lateral epicondyle, tennis elbow
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leukocyte rich platelet rich plasmaBiological
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 TenotomyDevice
Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device
| Study group | Role | What they receive |
|---|---|---|
| Leukocyte rich platelet rich plasma injection | Experimental | Patients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon Receives: Biological: Leukocyte rich platelet rich plasma |
| Percutaneous tenotomy | Experimental | Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device Receives: Device: Percutaneous Tenotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jan 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2023 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded, parallel randomized control trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384809
- Sponsor's protocol ID
- STUDY20200165
- Status last verified
- Nov 2022
- First submitted
- 7 May 2020
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Leukocyte-rich Platelet Rich Plasma Injection to Percutaneous Tenotomy in the Treatment of Chronic Common Extensor Tendinopathy
- ClinicalTrials.gov ID
- NCT04384809
- Acronym / sponsor ID
- STUDY20200165
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- common extensor, lateral epicondyle, tennis elbow
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded, parallel randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Leukocyte rich platelet rich plasma injection | Experimental | Biological: Leukocyte rich platelet rich plasmaPatients will be injected with leukocyte rich platelet rich plasma in their common extensor tendon |
| Percutaneous tenotomy | Experimental | Device: Percutaneous TenotomyPatients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leukocyte rich platelet rich plasmaLeukocyte 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 | Biological | Leukocyte rich platelet rich plasma injection |
| Percutaneous TenotomyPatients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device | Device | Percutaneous tenotomy |
Primary outcome
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.
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Leukocyte rich platelet rich plasma and Percutaneous Tenotomy in people with Lateral Epicondylitis (Tennis Elbow), run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain: visual analogue scale (time frame: up to 12 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.