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Tendon Fenestration Versus Surgery for the Treatment of Chronic Lateral Epicondylosis

NCT02710682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-09-15

No results posted yet for this study

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

Interventions

PROCEDURE

Mini-open surgery

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.

DEVICE

Ultrasound-guided Tendon fenestration

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Nathalie Bureau, MD, MSc · CRCHUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-01-31
Completion
2020-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02710682 on ClinicalTrials.gov