Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis
Primary Purpose
Epicondylitis of the Elbow, Tennis Elbow
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mini-open surgery
Ultrasound-guided Tendon fenestration
Sponsored by
About this trial
This is an interventional treatment trial for Epicondylitis of the Elbow focused on measuring Lateral Epicondylitis of the elbow, Tendon Fenestration, Minimally invasive Surgery, Ultrasound-guided procedure, Ultrasonography, Elastography
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Centre hospitalier de l'Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Mini-open surgery
Ultrasound-guided Tendon fenestration
Arm Description
Surgery
Tendon fenestration
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
RA-WIS questionnaire
Proportion of patients with score of at least 17 points over the time. Mean change in the score over the time.
Grip strength without pain
Mean change over the time
Medication Quantitative Scale
Mean change over the time
Global Perception of Change
Proportion of patients reporting that their condition has significantly or moderately improved over the time
Level of satisfaction
Proportion of patients reporting that their condition has significantly or moderately satisfied over the time
Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound
Recursive partitioning analysis
Common Extensor Tendon Elasticity measured at ultrasound elastography
Recursive partitioning analysis
Full Information
NCT ID
NCT02710682
First Posted
March 8, 2016
Last Updated
June 6, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT02710682
Brief Title
Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis of the Elbow, Tennis Elbow
Keywords
Lateral Epicondylitis of the elbow, Tendon Fenestration, Minimally invasive Surgery, Ultrasound-guided procedure, Ultrasonography, Elastography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mini-open surgery
Arm Type
Active Comparator
Arm Description
Surgery
Arm Title
Ultrasound-guided Tendon fenestration
Arm Type
Experimental
Arm Description
Tendon fenestration
Intervention Type
Procedure
Intervention Name(s)
Mini-open surgery
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ultrasound-guided Tendon fenestration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Rated Tennis Elbow Evaluation
Description
Proportion of patients with a change of at least 11/100 points in the score of the Patient Rated Tennis Elbow Evaluation - 6 months
Time Frame
Baseline and 6 months post-intervention
Secondary Outcome Measure Information:
Title
Patient Rated Tennis Elbow Evaluation
Description
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.
Time Frame
Baseline and 6 weeks, 3 months, 12 months post-intervention
Title
QuickDASH main module
Description
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.
Time Frame
Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Title
QuickDASH Work module
Description
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.
Time Frame
Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Title
RA-WIS questionnaire
Description
Proportion of patients with score of at least 17 points over the time. Mean change in the score over the time.
Time Frame
Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Title
Grip strength without pain
Description
Mean change over the time
Time Frame
Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Title
Medication Quantitative Scale
Description
Mean change over the time
Time Frame
6 weeks, 3 months, 6 months and 12 months post-intervention
Title
Global Perception of Change
Description
Proportion of patients reporting that their condition has significantly or moderately improved over the time
Time Frame
6 weeks, 3 months, 6 months and 12 months post-intervention
Title
Level of satisfaction
Description
Proportion of patients reporting that their condition has significantly or moderately satisfied over the time
Time Frame
6 weeks, 3 months, 6 months and 12 months post-intervention
Title
Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound
Description
Recursive partitioning analysis
Time Frame
Baseline, 6 and 12 months post-intervention
Title
Common Extensor Tendon Elasticity measured at ultrasound elastography
Description
Recursive partitioning analysis
Time Frame
Baseline, 6 and 12 months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Bureau, MD, MSc
Organizational Affiliation
CRCHUM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29886446
Citation
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.
Results Reference
background
PubMed Identifier
35482125
Citation
Bureau 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 Reference
result
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Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis
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