Lateral EpicondylitisPhase 2NCT01618487
Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study
A Phase 2 study testing Arthroscopic tenotomy, Open tenotomy and Debridement and repair in people with Lateral Epicondylitis and Tennis Elbow, run by Christine M. Kleinert Institute for Hand and Microsurgery at 1 site in United States.
Trial summary
The investigator hopes to determine if one of three current standard of care surgeries for lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are: arthroscopic tenotomy, open tenotomy, and debridement and repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis, Tennis Elbow
- What is being tested?
- Arthroscopic tenotomy, Open tenotomy and Debridement and repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2019
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 yrs old
- pain over the lateral epicondyle (via palpitation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for a duration of greater than 6 months prior to enrollment
- conservative treatment has failed and surgical intervention is recommend as standard of care
- ability to give informed consent
Who cannot join
- had surgery by a physician or specialist within the last 2 years as treatment for lateral epicondylitis
- congenital deformities, tendon ruptures or elbow fractures within the past year
- co-existing elbow diagnosis (i.e. osteoarthritis or instability)
- pregnant women, women trying to get pregnant, or breastfeeding mothers
- under the age of 18 or over 65
- incapable of giving informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Christine M. Kleinert Institute of Hand and Microsurgery
Louisville, Kentucky, 40202
Christina L Kaufman, PhD, 502-562-0390, ckaufman@cmki.org
Millicent L Horn, BS, 502-562-0307, mhorn@cmki.org
About this study
Official title: Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study
The investigator hopes to determine if one of three current standard of care surgeries for lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are: arthroscopic tenotomy, open tenotomy, and debridement and repair.
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Being tested
- Arthroscopic tenotomy, Open tenotomy, Debridement and repair
- Keywords
- tennis elbow, lateral epicondylitis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic tenotomyProcedure or surgery
This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.
Open tenotomyProcedure or surgery
This involves opening the skin on the arm up to expose the muscle and tendon. There is a total of 1 incision made.
Debridement and repairProcedure or surgery
This involves using an arthroscopic technique (using a scope and a small incision) to go in and remove any tissue that is diseased/does not belong and repairing the tear(s) in the tendon. There is a total of 1-2 incisions made.
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic tenotomy | Active comparator | Patients who are in this group will have arthroscopic tenotomy. A scope is used to see the tendon and release it. Receives: Procedure: Arthroscopic tenotomy |
| Open tenotomy | Active comparator | Patients in this group will undergo open tenotomy. This involves opening the skin to expose the muscle and tendon, and then the tendon is released. Receives: Procedure: Open tenotomy |
| Debridement and repair | Active comparator | The patients in this group will undergo an arthroscopic technique (scope and small incision) to go in and remove any tissue that is diseased/does not belong and repair the tear(s) in the tendon. Receives: Procedure: Debridement and repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation)
The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christine M. Kleinert Institute for Hand and Microsurgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tuna Ozyurekoglu, MD, Principal investigator, Christine M. Kleinert Institute of Hand and Microsurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618487
- Sponsor's protocol ID
- 11.0565
- Status last verified
- Jan 2018
- First submitted
- 11 Jun 2012
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT01618487
- Acronym / sponsor ID
- 11.0565
- Conditions
- Lateral Epicondylitis, Tennis Elbow
- Keywords
- tennis elbow, lateral epicondylitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Christine M. Kleinert Institute for Hand and MicrosurgeryUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 13 Jun 2012 (estimated)
- 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.
The investigator hopes to determine if one of three current standard of care surgeries for lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are: arthroscopic tenotomy, open tenotomy, and debridement and repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic tenotomy | Active comparator | Procedure: Arthroscopic tenotomyPatients who are in this group will have arthroscopic tenotomy. A scope is used to see the tendon and release it. |
| Open tenotomy | Active comparator | Procedure: Open tenotomyPatients in this group will undergo open tenotomy. This involves opening the skin to expose the muscle and tendon, and then the tendon is released. |
| Debridement and repair | Active comparator | Procedure: Debridement and repairThe patients in this group will undergo an arthroscopic technique (scope and small incision) to go in and remove any tissue that is diseased/does not belong and repair the tear(s) in the tendon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 yrs old
- pain over the lateral epicondyle (via palpitation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for a duration of greater than 6 months prior to enrollment
- conservative treatment has failed and surgical intervention is recommend as standard of care
- ability to give informed consent
Key exclusion criteria (6 listed)
- had surgery by a physician or specialist within the last 2 years as treatment for lateral epicondylitis
- congenital deformities, tendon ruptures or elbow fractures within the past year
- co-existing elbow diagnosis (i.e. osteoarthritis or instability)
- pregnant women, women trying to get pregnant, or breastfeeding mothers
- under the age of 18 or over 65
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 |
|---|---|---|
| Arthroscopic tenotomyThis is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it. | Procedure or surgery | Arthroscopic tenotomy |
| Open tenotomyThis involves opening the skin on the arm up to expose the muscle and tendon. There is a total of 1 incision made. | Procedure or surgery | Open tenotomy |
| Debridement and repairThis involves using an arthroscopic technique (using a scope and a small incision) to go in and remove any tissue that is diseased/does not belong and repairing the tear(s) in the tendon. There is a total of 1-2 incisions made. | Procedure or surgery | Debridement and repair |
Primary outcome
symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation)
Time frame: 24 months
The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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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.
Tuna Ozyurekoglu, MD principal investigator
Christine M. Kleinert Institute of Hand and Microsurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arthroscopic tenotomy, Open tenotomy and Debridement and repair in people with Lateral Epicondylitis and Tennis Elbow, run by Christine M. Kleinert Institute for Hand and Microsurgery 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jan 2018. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuna Ozyurekoglu, MD (502-561-4286, tozyurekoglu@kleinertkutz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation) (time frame: 24 months). 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 25 Jan 2018.