Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis

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.

Study Overview

• Status: Completed
• Conditions: Tennis Elbow; Epicondylitis of the Elbow
• Intervention / Treatment: Procedure: Mini-open surgery; Device: Ultrasound-guided Tendon fenestration

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Université de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mini-open surgery; Surgery	Procedure: Mini-open 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.
Experimental: Ultrasound-guided Tendon fenestration; Tendon fenestration	Device: Ultrasound-guided Tendon fenestration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 6 months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Grip strength without pain	Mean change over the time	Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention
Medication Quantitative Scale	Mean change over the time	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	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	6 weeks, 3 months, 6 months and 12 months post-intervention
Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound	Recursive partitioning analysis	Baseline, 6 and 12 months post-intervention
Common Extensor Tendon Elasticity measured at ultrasound elastography	Recursive partitioning analysis	Baseline, 6 and 12 months post-intervention

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Nathalie Bureau, MD, MSc, CRCHUM

Publications and helpful links

General 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.
• Bureau NJ, Tétreault P, Grondin P, Freire V, Desmeules F, Cloutier G, Julien AS, Choinière 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 Apr 28. doi: 10.1007/s00330-022-08794-4. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 11, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasonography; Elastography; Lateral Epicondylitis of the elbow; Tendon Fenestration; Minimally invasive Surgery; Ultrasound-guided procedure
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow
• Other Study ID Numbers: CE 15.327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No