Arthroscopic Surgery vs Non-Operative Treatment for Tennis Elbow

Overseen By J W Pollock, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Previous elbow trauma, Cognitive difficulties, others

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-operative period

68 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

Who Is on the Research Team?

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

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?

Group I: Arthroscopic tennis elbow release Active Control 1 Intervention

This group will have arthroscopic tennis elbow release through a standard, two-portal technique,

Group II: Non Operative Placebo Group 1 Intervention

control group will not undergo a second portal or muscle release.

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

Approved in European Union as Arthroscopic tennis elbow release for:

• Chronic lateral epicondylitis
• Tennis elbow

Approved in United States as Arthroscopic tennis elbow release for:

• Chronic lateral epicondylitis
• Tennis elbow

Approved in Canada as Arthroscopic tennis elbow release for:

• Chronic lateral epicondylitis
• Tennis elbow

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm Results of Arthroscopic Treatment for Recalcitrant Lateral Epicondylitis of the Elbow. Saremi, H., Seydan, MA., Seifrabiei, MA.[2022]

Conservative treatments for lateral epicondylitis (tennis elbow) show a high success rate of 70-90% after one year, but some cases may require surgical intervention.

The described three-portal arthroscopic technique for treating lateral epicondylitis offers better visualization and lower morbidity compared to traditional open surgery, allowing for quicker recovery and return to normal activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Three-Portal Technique in Arthroscopic Lateral Epicondylitis Release. Gowda, A., Kennedy, G., Gallacher, S., et al.[2020]

A systematic review of 34 studies involving 1508 patients with lateral epicondylitis found no significant difference in pain relief and functional outcomes between open and arthroscopic surgery techniques.

However, the arthroscopic procedure was associated with significantly fewer postoperative complications compared to the open surgery method (33.4% vs 57.3%), suggesting it may be a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Open versus Arthroscopic Surgery for Lateral Epicondylitis, Evidence from a Systematic Review. Moradi, A., Pasdar, P., Mehrad-Majd, H., et al.[2022]

The overall complication rate for lateral epicondylar release procedures is low at 3.3%, with open procedures having the highest rate at 4.3%, while percutaneous and arthroscopic methods show lower rates of 1.9% and 1.1%, respectively.

In higher-level studies that directly compared the different surgical methods, complication rates were even lower, indicating that both percutaneous and arthroscopic techniques may offer safer options for managing lateral epicondylitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Lateral Epicondylar Release. Pomerantz, ML.[2022]

In a study of 87 patients with resistant lateral epicondylitis, both open and arthroscopic release procedures showed similar outcomes, with 69% of open cases and 72% of arthroscopic cases achieving good or excellent results.

Patients who underwent arthroscopic release returned to work sooner and needed less postoperative therapy compared to those who had open release, suggesting a potential advantage in recovery time with the arthroscopic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lateral epicondylitis: a comparative study of open and arthroscopic lateral release. Peart, RE., Strickler, SS., Schweitzer, KM.[2022]

In a study of 61 patients who underwent open surgical release for tennis elbow, 96.7% reported symptom improvement post-surgery, indicating the procedure is highly effective.

Patients with diabetes mellitus experienced worse outcomes, including higher pain scores, reduced grip strength, and increased recurrence rates, highlighting the need for careful preoperative counseling for diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcome assessment after open tennis elbow release: what are the predictor parameters? Siddiqui, MA., Koh, J., Kua, J., et al.[2011]

A study involving 24 patients with tennis elbow showed that small incision surgical techniques resulted in significant improvements in pain and function, with the mean visual analog scale (VAS) score decreasing from 7.2 to 3.5 points after surgery.

The procedure demonstrated a low complication rate and high patient satisfaction, making it a recommended option for those who do not respond to non-operative treatments for tennis elbow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Treatment of Tennis Elbow; Minimal Incision Technique. Amroodi, MN., Mahmuudi, A., Salariyeh, M., et al.[2020]

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