Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis

NCT02710682 | Completed

• 1 other identifier: CE 15.327
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Epicondylitis of the Elbow; Tennis Elbow

Keywords

Lateral Epicondylitis of the elbow; Tendon Fenestration; Minimally invasive Surgery; Ultrasound-guided procedure; Ultrasonography; Elastography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Patient Rated Tennis Elbow Evaluation

  Baseline and 6 weeks, 3 months, 12 months post-intervention

• QuickDASH main module

  Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention

• QuickDASH Work module

  Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention

• RA-WIS questionnaire

  Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention

• Grip strength without pain

  Baseline and 6 weeks, 3 months, 6 months and 12 months post-intervention

Study Arms (2)

Mini-open surgery

ACTIVE COMPARATOR

Surgery

Procedure: Mini-open surgery

Ultrasound-guided Tendon fenestration

EXPERIMENTAL

Tendon fenestration

Device: Ultrasound-guided Tendon fenestration

Interventions

Mini-open surgery PROCEDURE

This 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.

Mini-open surgery

Ultrasound-guided Tendon fenestration DEVICE

This 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.

Ultrasound-guided Tendon fenestration

Eligibility Criteria

• Age: 30 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

Location

Related Publications (3)

• 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.

  PMID: 29886446 BACKGROUND

• 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.

  PMID: 35482125 RESULT

• Tobaly 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.

  PMID: 38734857 RESULT

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Nathalie Bureau, MD, MSc

  CRCHUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 17, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 15, 2025

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)