68 Participants Needed

Arthroscopic Surgery vs Non-Operative Treatment for Tennis Elbow

KM
JW
Overseen ByJ W Pollock, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Hospital Research Institute

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if arthroscopic surgery, a minimally invasive procedure using small incisions and a camera, effectively treats chronic tennis elbow compared to non-surgical methods. Researchers will divide participants into two groups: one will receive the surgical procedure, and the other will not undergo surgery. The study targets individuals who have experienced tennis elbow symptoms for over six months without relief from other treatments. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance treatment options for chronic tennis elbow.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that arthroscopic tennis elbow release is safe?

Research has shown that arthroscopic surgery for tennis elbow is generally safe. Studies have found that 91% to 97.7% of patients experience improvement after this procedure.

Both arthroscopic and open surgeries for tennis elbow have similar safety profiles and risks, indicating that the arthroscopic method is as safe as traditional open surgery. The success rate is also high; one study reported a 92% success rate for the arthroscopic approach. Although all surgeries carry some risks, these figures suggest that this procedure is well-tolerated by patients.12345

Why are researchers excited about this trial's treatments?

Most treatments for tennis elbow focus on rest, physical therapy, or injections to manage pain and inflammation. However, the arthroscopic tennis elbow release is unique because it involves a minimally invasive surgical technique that directly addresses the affected tendons through a two-portal approach. Researchers are excited about this method because it has the potential to provide faster and more effective relief by precisely targeting and releasing the damaged tissue, potentially leading to quicker recovery times compared to traditional non-operative treatments.

What evidence suggests that this trial's treatments could be effective for tennis elbow?

This trial will compare arthroscopic surgery for tennis elbow with non-operative treatment. Research has shown that arthroscopic surgery yields promising results. In past studies, 91% to 97.7% of patients improved after the procedure, indicating that many people feel much better and can use their arm more easily afterward. Some studies also mention that the duration of symptoms before surgery might not affect its effectiveness. Overall, these findings strongly suggest that arthroscopic surgery can effectively treat long-lasting tennis elbow.13678

Who Is on the Research Team?

JW

J W Pollock, MD

Principal Investigator

The Ottawa Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had tennis elbow symptoms for over 6 months and treatments haven't worked.
I am over 18 years old and my bones have stopped growing.
Provision of informed consent

Exclusion Criteria

I have tennis elbow on both arms.
I am able to understand and provide consent, and can reliably complete questionnaires.
Alternative diagnosis that better explain their symptoms
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either arthroscopic tennis elbow release or non-operative management

Immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Arthroscopic tennis elbow release
  • Non operative
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Arthroscopic tennis elbow releaseActive Control1 Intervention
Group II: Non OperativePlacebo Group1 Intervention

Arthroscopic tennis elbow release is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Arthroscopic tennis elbow release for:
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Approved in United States as Arthroscopic tennis elbow release for:
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Approved in Canada as Arthroscopic tennis elbow release for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Published Research Related to This Trial

Lateral epicondylitis, commonly known as tennis elbow, affects 1% to 3% of the population, primarily those aged 35 to 50, and is characterized by a failure of the tendon to heal rather than inflammation.
Most cases respond well to nonsurgical treatments like physical therapy and corticosteroid injections, but if these fail, arthroscopic surgery has a high success rate, with improvement reported in 91% to 97.7% of patients.
Arthroscopic tennis elbow release.Savoie, FH., O'Brien, MJ.[2022]
Lateral epicondylitis, commonly known as tennis elbow, affects 1% to 3% of the population and is primarily caused by overloading the tendon, particularly at the extensor carpi radialis brevis, despite the term 'epicondylitis' suggesting inflammation.
Nonsurgical treatments, such as rest, physiotherapy, and platelet-rich plasma injections, are preferred, while surgery is considered only if pain and functional disability persist, with both open and arthroscopic techniques showing good outcomes.
LATERAL EPICONDYLITIS OF THE ELBOW.Cohen, M., da Rocha Motta Filho, G.[2022]
Arthroscopic surgery for recalcitrant lateral epicondylitis significantly reduced pain levels, with the visual analog scale (VAS) scores dropping from an average of 7.05 before surgery to 3.20 after surgery over a follow-up period of 42 months.
The Quick DASH score, which measures elbow function, improved from 63.18 to 25.68 post-surgery, indicating a substantial enhancement in patients' daily activities and overall arm function.
Midterm Results of Arthroscopic Treatment for Recalcitrant Lateral Epicondylitis of the Elbow.Saremi, H., Seydan, MA., Seifrabiei, MA.[2022]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/20188266/
Arthroscopic tennis elbow releaseSatisfactory results of the arthroscopic surgical procedures have been documented, with reported improvement rates of 91% to 97.7%. The recent advances in ...
Arthroscopic tennis elbow release - PMCThis article will explain and review the current literature regarding this procedure and the potential benefits of this technique.
A randomized, double-blind sham-controlled trial on the ...The purpose of this prospective, randomized sham-controlled trial is to determine whether arthroscopic tennis elbow release is effective at ...
Outcomes of arthroscopic lateral epicondylitis releaseThis study found no evidence that the outcomes of arthroscopic ECRB release to treat lateral epicondylitis were associated with symptom duration.
Arthroscopic Repair of Extensor Carpi Radialis Brevis in ...We describe a technique for the release and repair of the extensor carpi radialis brevis tendon using an arthroscopic approach.
Arthroscopic tennis elbow releaseMost cases of lateral epicondylitis respond to appropriate nonoperative treatment protocols. Nonoperative management includes medication, bracing, physical ...
A comparative meta-analysis of the efficacy and safety ...Arthroscopic and open release techniques for lateral epicondylitis provide similar functional outcomes and complication rates. However, arthroscopic surgery may ...
Is There any Difference in Clinical Outcome between Open ...Improved clinical results were achieved after treatment with either open or arthroscopic treatment. The surgical success rate was 95.6% in open surgery and 92. ...
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