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Arthroscopic Surgery vs Non-Operative Treatment for Tennis Elbow

N/A
Recruiting
Led By J W Pollock, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptoms consistent with lateral epicondylitis persisting for >6 months, and have failed conservative management
Adult, skeletally mature (>18yrs)
Must not have
Bilateral lateral epicondylitis
Cognitive difficulties that prevent ability to provide informed consent and reliable completion of questionnaires
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of enrollment up until 2-years post-operative

Summary

This trial will compare two different surgical treatments for chronic tennis elbow in order to determine which is more effective.

Who is the study for?
This trial is for individuals who have been experiencing tennis elbow symptoms for at least 9 months and haven't improved with standard treatments. It's not suitable for those with workers' compensation claims, previous severe elbow injuries or surgeries, or other conditions that better explain their symptoms.
What is being tested?
The study is comparing two surgical methods to treat chronic tennis elbow: arthroscopic release versus arthroscopic debridement. Participants will be randomly assigned to one of the procedures in a double-blind setting to determine which is more effective.
What are the potential side effects?
Potential side effects may include pain at the surgery site, swelling, stiffness in the elbow, infection risk from surgery, and possible damage to nearby nerves or blood vessels during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had tennis elbow symptoms for over 6 months and treatments haven't worked.
Select...
I am over 18 years old and my bones have stopped growing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have tennis elbow on both arms.
Select...
I am able to understand and provide consent, and can reliably complete questionnaires.
Select...
I have had previous elbow trauma or surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of enrollment up until 2-years post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of enrollment up until 2-years post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Mayo Elbow Performance Score
Secondary study objectives
Adverse Events
Elbow
Hand
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Arthroscopic tennis elbow releaseActive Control1 Intervention
This group will have arthroscopic tennis elbow release through a standard, two-portal technique,
Group II: Non OperativePlacebo Group1 Intervention
control group will not undergo a second portal or muscle release.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,880 Total Patients Enrolled
J W Pollock, MDPrincipal InvestigatorThe Ottawa Hospital

Media Library

Arthroscopic tennis elbow release Clinical Trial Eligibility Overview. Trial Name: NCT02236689 — N/A
Tennis Elbow Research Study Groups: Arthroscopic tennis elbow release, Non Operative
Tennis Elbow Clinical Trial 2023: Arthroscopic tennis elbow release Highlights & Side Effects. Trial Name: NCT02236689 — N/A
Arthroscopic tennis elbow release 2023 Treatment Timeline for Medical Study. Trial Name: NCT02236689 — N/A
~3 spots leftby Jun 2025
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