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Ultrasound-guided Tendon fenestration for Tennis Elbow

N/A
Waitlist Available
Led By Nathalie Bureau, MD, MSc
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3 months, 6 months and 12 months post-intervention
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Tennis Elbow

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3 months, 6 months and 12 months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3 months, 6 months and 12 months post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Common Extensor Tendon Elasticity measured at ultrasound elastography
Common Extensor Tendon Morphometric parameters measured at B-mode ultrasound
Global Perception of Change
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ultrasound-guided Tendon fenestrationExperimental Treatment1 Intervention
Tendon fenestration
Group II: Mini-open surgeryActive Control1 Intervention
Surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound-guided Tendon fenestration
2016
N/A
~70

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,456 Total Patients Enrolled
Nathalie Bureau, MD, MScPrincipal InvestigatorCRCHUM
~7 spots leftby Dec 2025