Epicondylitis of the ElbowNCT02710682
Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis
A study testing Mini-open surgery and Ultrasound-guided Tendon fenestration in people with Epicondylitis of the Elbow and Tennis Elbow, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent, painful syndrome of the elbow. It is refractory to conservative treatment measures, including rest, excentric and concentric exercises in approximately 20% of patients after 6 months. Read more about this study
- Who is it for?
- Ages 30 to 67 years
- Conditions the study is for
- Epicondylitis of the Elbow, Tennis Elbow
- What is being tested?
- Mini-open surgery and Ultrasound-guided Tendon fenestration
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Jul 2020
- Phase
- Interventional
- 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 30 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Workers
- Ability to read, understand and answer questionnaires in French or English
- Diagnosis of unilateral, lateral epicondylosis established by an orthopaedist, determined by clinical presentation and pain, ≥ 4/10 on a pain numerical rating scale, on palpation of the region slightly anterior and distal to the lateral epicondyle, exacerbated by the extension of the wrist or the middle finger when the elbow is in extension.
- Chronic epicondylosis, refractory to medical treatment conducted for at least six months, which includes rest and implementation of ergonomics to avoid soliciting the extensor tendons, and at least one of: physical therapy, a rehabilitation program with stretching and / or strengthening exercises, injection treatments (corticosteroids, autologous PRP) or extracorporeal shock waves.
Who cannot join
- Suspected tumor or infectious etiology
- Injection of corticosteroids during the last 3 months
- Hemorrhagic diathesis; anticoagulation (platelets <50,000, International Normalized Ratio (INR) > 2)
- Local infection
- History of elbow surgery or fracture
- History of inflammatory arthropathy
- Neck pain and radiculopathy
- Inability to provide informed consent because of a language problem, dementia or a major psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
About this study
Official title: Ultrasound-guided Tendon Fenestration Versus Open Surgery for the Treatment of Chronic Lateral Epicondylosis of the Elbow: a Prospective, Randomized, Single Blind, Pilot Study.
Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent, painful syndrome of the elbow. It is refractory to conservative treatment measures, including rest, excentric and concentric exercises in approximately 20% of patients after 6 months. Corticosteroid injections can provide relief in the short term. Mini-open surgery may be proposed when the conservative treatment fails and studies have shown an efficacy of 70%. Ultrasound-guided tendon fenestration is a minimally-invasive technique which stimulates the physiological healing mechanisms of the tendon and appears promising for the treatment of chronic tendinopathies. To our knowledge, no studies have compared the US-guided fenestration technique to mini-open surgery for the treatment of chronic lateral epicondylosis.
The primary objective of this pilot study is to compare the efficacy of US-guided fenestration to mini-open surgery to reduce pain and improve functional status in workers suffering from chronic lateral epicondylosis refractory to 6-month conservative treatment.
This is a prospective single-blind randomized pilot study. Sixty-four subjects will be randomized into two intervention groups for treatment either by US-guided fenestration or mini-open surgery. The primary outcome of the study will be the Patient Rated Tennis Elbow Evaluation (PRTEE) score at 6 month post-procedure.
Read the detailed description
STUDY DESIGN:
Phase II, prospective, two-arm, single-blind randomized controlled study.
SETTING:
Up to 64 patients (56 + 15% loss to follow-up) suffering from chronic lateral epicondylosis will be recruited by one of two orthopedists working in a specialized outpatient clinic, at the Centre Hospitalier de l'Université de Montréal (CHUM), a tertiary care academic center. Ultrasound examination of the elbow will be performed before the interventions.
RANDOMIZATION:
Using a computerized randomization list, the subjects will be randomized into the 2 treatment arms to be treated either by an US-guided tendon fenestration technique or by mini-open surgery. Randomization will be stratified by block sizes of 8.
FOLLOW UP Subjects' follow-up will extend over a period of 12 months - i.e., at 6 weeks and 3, 6 and 12 months post-intervention. The primary outcome will be the PRTEE score. Secondary outcomes will evaluate the impact of each procedure on: Pain-free grip (dynamometer), Medication Quantitative Scale, working activity (QuickDASH general and work modules; RA-WIS), Patient Global Impression of Change and Patient Satisfaction. The ultrasound examination will be repeated at 6 and 12 months. The predictive value of various B-mode parameters, color Doppler and elastography will be explored.
ANALYSIS:
The primary endpoint will be the proportion of subjects in each intervention arm presenting a reduction of at least 11/100 of the PRTEE score at 6 months post-intervention. The Fisher's exact test will be used to compare the proportion of subjects in each treatment group. The primary analysis will follow the intention-to-treat principle. Regarding the secondary endpoints, an ANOVA for repeated measures with two factors (time and group), a Fisher's exact test or a recursive partitioning analysis will be performed as appropriate.
- Conditions
- Epicondylitis of the Elbow, Tennis Elbow
- Being tested
- Mini-open surgery, Ultrasound-guided Tendon fenestration
- Keywords
- Lateral Epicondylitis of the elbow, Tendon Fenestration, Minimally invasive Surgery, Ultrasound-guided procedure, Ultrasonography, Elastography
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-open surgeryProcedure or surgery
This treatment will be administered by an orthopedic surgeon specialized in upper limb surgery.
- Skin disinfection; Local anesthesia (lidocaine 1%).
- Skin incision, slightly anterior to lateral epicondyle.
- Exposure of the plane between the tendon and fascia.
- Extensor Carpi Radialis Longus (ECRL) tendon is lifted to expose the Extensor Carpi Radialis Brevis (ECRB) tendon.
- Excision of diseased tissue of the ECRB tendon.
- ECRL tendon is sutured back to the fascia. The skin is closed.
- Patient is monitored for 30 minutes after procedure.
Ultrasound-guided Tendon fenestrationDevice
This treatment will be administered by a fellowship-trained MSK radiologist.
- Patient's elbow at 70 degrees of flexion with the forearm pronated resting on an examination table.
- Skin disinfection. Local anesthesia, skin, superficial fascia and tendon, with lidocaine 1%.
- Using a 22 G needle under continuous ultrasound guidance, several passes (about 20-30) within the abnormal area of the tendon, contacting the bone, until the area softens.
- Patient monitored for 30 minutes, before being discharged.
| Study group | Role | What they receive |
|---|---|---|
| Mini-open surgery | Active comparator | Surgery Receives: Procedure: Mini-open surgery |
| Ultrasound-guided Tendon fenestration | Experimental | Tendon fenestration Receives: Device: Ultrasound-guided Tendon fenestration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Tennis Elbow Evaluation
Proportion of patients with a change of at least 11/100 points in the score of the Patient Rated Tennis Elbow Evaluation - 6 months
Measured: Baseline and 6 months post-intervention
Secondary outcomes (10)
Patient Rated Tennis Elbow Evaluation
Proportion of patients with a change of at least 11/100 points in the score over the time.
Mean change in the score over the time.
Measured: Baseline and 6 weeks, 3 months, 12 months post-intervention
QuickDASH main module
Proportion of patients with a change of at least 8/100 points in the score over the time.
Mean change in the score over the time.
Measured: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
QuickDASH Work module
Proportion of patients with a change of at least 8/100 points in the score over the time.
Mean change in the score over the time.
Measured: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
RA-WIS questionnaire
Proportion of patients with score of at least 17 points over the time. Mean change in the score over the time.
Measured: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Grip strength without pain
Mean change over the time
Measured: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Medication Quantitative Scale
Mean change over the time
Measured: 6 weeks, 3 months, 6 months and 12 months post-intervention
Global Perception of Change
Proportion of patients reporting that their condition has significantly or moderately improved over the time
Measured: 6 weeks, 3 months, 6 months and 12 months post-intervention
Level of satisfaction
Proportion of patients reporting that their condition has significantly or moderately satisfied over the time
Measured: 6 weeks, 3 months, 6 months and 12 months post-intervention
Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound
Recursive partitioning analysis
Measured: Baseline, 6 and 12 months post-intervention
Common Extensor Tendon Elasticity measured at ultrasound elastography
Recursive partitioning analysis
Measured: Baseline, 6 and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epicondylitis of the ElbowStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Bureau, MD, MSc, Principal investigator, CRCHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710682
- Sponsor's protocol ID
- CE 15.327
- Status last verified
- Jun 2022
- First submitted
- 8 Mar 2016
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lungu E, Grondin P, Tetreault P, Desmeules F, Cloutier G, Choiniere M, Bureau NJ. Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study. BMJ Open. 2018 Jun 9;8(6):e021373. doi: 10.1136/bmjopen-2017-021373.
PubMed 29886446Bureau NJ, Tetreault P, Grondin P, Freire V, Desmeules F, Cloutier G, Julien AS, Choiniere M. Treatment of chronic lateral epicondylosis: a randomized trial comparing the efficacy of ultrasound-guided tendon dry needling and open-release surgery. Eur Radiol. 2022 Nov;32(11):7612-7622. doi: 10.1007/s00330-022-08794-4. Epub 2022 Apr 28.
PubMed 35482125Tobaly D, Tetreault P, Cloutier G, Choiniere M, Grondin P, Freire V, Julien AS, Bureau NJ. Assessing the treatment response of lateral elbow tendinopathy using time-dependent ultrasonography, Doppler imaging, and elastography. Insights Imaging. 2024 May 11;15(1):113. doi: 10.1186/s13244-024-01695-8.
PubMed 38734857
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Tendon Fenestration Versus Open Surgery for the Treatment of Chronic Lateral Epicondylosis of the Elbow: a Prospective, Randomized, Single Blind, Pilot Study.
- ClinicalTrials.gov ID
- NCT02710682
- Acronym / sponsor ID
- CE 15.327
- Conditions
- Epicondylitis of the Elbow, Tennis Elbow
- Keywords
- Lateral Epicondylitis of the elbow, Tendon Fenestration, Minimally invasive Surgery, Ultrasound-guided procedure, Ultrasonography, Elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 17 Mar 2016 (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.
Lateral epicondylosis, also called tennis elbow or lateral epicondylitis, is a prevalent, painful syndrome of the elbow. It is refractory to conservative treatment measures, including rest, excentric and concentric exercises in approximately 20% of patients after 6 months. Corticosteroid injections can provide relief in the short term. Mini-open surgery may be proposed when the conservative treatment fails and studies have shown an efficacy of 70%. Ultrasound-guided tendon fenestration is a minimally-invasive technique which stimulates the physiological healing mechanisms of the tendon and appears promising for the treatment of chronic tendinopathies. To our knowledge, no studies have compared the US-guided fenestration technique to mini-open surgery for the treatment of chronic lateral epicondylosis.
The primary objective of this pilot study is to compare the efficacy of US-guided fenestration to mini-open surgery to reduce pain and improve functional status in workers suffering from chronic lateral epicondylosis refractory to 6-month conservative treatment.
This is a prospective single-blind randomized pilot study. Sixty-four subjects will be randomized into two intervention groups for treatment either by US-guided fenestration or mini-open surgery. The primary outcome of the study will be the Patient Rated Tennis Elbow Evaluation (PRTEE) score at 6 month post-procedure.
Detailed description
STUDY DESIGN:
Phase II, prospective, two-arm, single-blind randomized controlled study.
SETTING:
Up to 64 patients (56 + 15% loss to follow-up) suffering from chronic lateral epicondylosis will be recruited by one of two orthopedists working in a specialized outpatient clinic, at the Centre Hospitalier de l'Université de Montréal (CHUM), a tertiary care academic center. Ultrasound examination of the elbow will be performed before the interventions.
RANDOMIZATION:
Using a computerized randomization list, the subjects will be randomized into the 2 treatment arms to be treated either by an US-guided tendon fenestration technique or by mini-open surgery. Randomization will be stratified by block sizes of 8.
FOLLOW UP Subjects' follow-up will extend over a period of 12 months - i.e., at 6 weeks and 3, 6 and 12 months post-intervention. The primary outcome will be the PRTEE score. Secondary outcomes will evaluate the impact of each procedure on: Pain-free grip (dynamometer), Medication Quantitative Scale, working activity (QuickDASH general and work modules; RA-WIS), Patient Global Impression of Change and Patient Satisfaction. The ultrasound examination will be repeated at 6 and 12 months. The predictive value of various B-mode parameters, color Doppler and elastography will be explored.
ANALYSIS:
The primary endpoint will be the proportion of subjects in each intervention arm presenting a reduction of at least 11/100 of the PRTEE score at 6 months post-intervention. The Fisher's exact test will be used to compare the proportion of subjects in each treatment group. The primary analysis will follow the intention-to-treat principle. Regarding the secondary endpoints, an ANOVA for repeated measures with two factors (time and group), a Fisher's exact test or a recursive partitioning analysis will be performed as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-open surgery | Active comparator | Procedure: Mini-open surgerySurgery |
| Ultrasound-guided Tendon fenestration | Experimental | Device: Ultrasound-guided Tendon fenestrationTendon fenestration |
Who may qualify
- Ages
- 30 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Workers
- Ability to read, understand and answer questionnaires in French or English
- Diagnosis of unilateral, lateral epicondylosis established by an orthopaedist, determined by clinical presentation and pain, ≥ 4/10 on a pain numerical rating scale, on palpation of the region slightly anterior and distal to the lateral epicondyle, exacerbated by the extension of the wrist or the middle finger when the elbow is in extension.
- Chronic epicondylosis, refractory to medical treatment conducted for at least six months, which includes rest and implementation of ergonomics to avoid soliciting the extensor tendons, and at least one of: physical therapy, a rehabilitation program with stretching and / or strengthening exercises, injection treatments (corticosteroids, autologous PRP) or extracorporeal shock waves.
Key exclusion criteria (8 listed)
- Suspected tumor or infectious etiology
- Injection of corticosteroids during the last 3 months
- Hemorrhagic diathesis; anticoagulation (platelets <50,000, International Normalized Ratio (INR) > 2)
- Local infection
- History of elbow surgery or fracture
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 |
|---|---|---|
| Mini-open surgeryThis treatment will be administered by an orthopedic surgeon specialized in upper limb surgery. 1. Skin disinfection; Local anesthesia (lidocaine 1%). 2. Skin incision, slightly anterior to lateral epicondyle. 3. Exposure of the plane between the tendon and fascia. 4. Extensor Carpi Radialis Longus (ECRL) tendon is lifted to expose the Extensor Carpi Radialis Brevis (ECRB) tendon. 5. Excision of diseased tissue of the ECRB tendon. 6. ECRL tendon is sutured back to the fascia. The skin is closed. 7. Patient is monitored for 30 minutes after procedure. | Procedure or surgery | Mini-open surgery |
| Ultrasound-guided Tendon fenestrationThis treatment will be administered by a fellowship-trained MSK radiologist. 1. Patient's elbow at 70 degrees of flexion with the forearm pronated resting on an examination table. 2. Skin disinfection. Local anesthesia, skin, superficial fascia and tendon, with lidocaine 1%. 3. Using a 22 G needle under continuous ultrasound guidance, several passes (about 20-30) within the abnormal area of the tendon, contacting the bone, until the area softens. 4. Patient monitored for 30 minutes, before being discharged. | Device | Ultrasound-guided Tendon fenestration |
Primary outcome
Patient Rated Tennis Elbow Evaluation
Time frame: Baseline and 6 months post-intervention
Proportion of patients with a change of at least 11/100 points in the score of the Patient Rated Tennis Elbow Evaluation - 6 months
10 secondary outcomes
Patient Rated Tennis Elbow Evaluation
Time frame: Baseline and 6 weeks, 3 months, 12 months post-intervention
QuickDASH main module
Time frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
QuickDASH Work module
Time frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
RA-WIS questionnaire
Time frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Grip strength without pain
Time frame: Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Medication Quantitative Scale
Time frame: 6 weeks, 3 months, 6 months and 12 months post-intervention
Global Perception of Change
Time frame: 6 weeks, 3 months, 6 months and 12 months post-intervention
Level of satisfaction
Time frame: 6 weeks, 3 months, 6 months and 12 months post-intervention
Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound
Time frame: Baseline, 6 and 12 months post-intervention
Common Extensor Tendon Elasticity measured at ultrasound elastography
Time frame: Baseline, 6 and 12 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 29886446Lungu E, Grondin P, Tetreault P, Desmeules F, Cloutier G, Choiniere M, Bureau NJ. Ultrasound-guided tendon fenestration versus open-release surgery for the treatment of chronic lateral epicondylosis of the elbow: protocol for a prospective, randomised, single blinded study. BMJ Open. 2018 Jun 9;8(6):e021373. doi: 10.1136/bmjopen-2017-021373.
- Results publication: PubMed 35482125Bureau NJ, Tetreault P, Grondin P, Freire V, Desmeules F, Cloutier G, Julien AS, Choiniere M. Treatment of chronic lateral epicondylosis: a randomized trial comparing the efficacy of ultrasound-guided tendon dry needling and open-release surgery. Eur Radiol. 2022 Nov;32(11):7612-7622. doi: 10.1007/s00330-022-08794-4. Epub 2022 Apr 28.
- Results publication: PubMed 38734857Tobaly D, Tetreault P, Cloutier G, Choiniere M, Grondin P, Freire V, Julien AS, Bureau NJ. Assessing the treatment response of lateral elbow tendinopathy using time-dependent ultrasonography, Doppler imaging, and elastography. Insights Imaging. 2024 May 11;15(1):113. doi: 10.1186/s13244-024-01695-8.
- Individual participant dataSharing planned: No
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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.
Nathalie Bureau, MD, MSc principal investigator
CRCHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-open surgery and Ultrasound-guided Tendon fenestration in people with Epicondylitis of the Elbow and Tennis Elbow, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 15 Sep 2025. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Rated Tennis Elbow Evaluation (time frame: Baseline and 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02710682, which also lists 3 linked publications.
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 15 Sep 2025.