Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Tennis Elbow

Treatments: Procedure: Non operative; Procedure: Arthroscopic tennis elbow release

Study type: Interventional

Funder types: Other

Identifiers

NCT02236689

20140553-01H

Details and patient eligibility

About

We propose a randomized, double-blind controlled trial comparing arthroscopic release with arthroscopic debridement for the management of chronic tennis elbow in an effort to definitively determine whether arthroscopic tennis elbow release is an effective treatment of tennis elbow, and to further provide better recommendations for the use of this procedure, in an effort to improve patient care.

Full description

Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a lifetime, most typically affecting individuals between the ages of 35 and 50.

Tennis elbow is a common occurrence in the general population that causes lateral elbow pain and diminished grip strength, which may be debilitating. Most affected individuals achieve symptom resolution within 6 months to 1 year with measures such as physiotherapy, anti-inflammatories and corticosteroid injections, but a small subset will go on to develop chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis elbow release (ATER), which has gained popularity in recent years as it presents a less invasive option, allows for direct visualization of the elbow joint for other pathology and has a faster return-to-work time compared to other surgical procedures. Despite its promise there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual efficacy of this procedure into question. A randomized controlled trial on arthroscopic tennis elbow release would provide much needed evidence in order to define its role in the management of tennis elbow and to help refine treatment protocols.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms consistent with lateral epicondylitis persisting for >6 months, and have failed conservative management
• Adult, skeletally mature (>18yrs)
• Provision of informed consent

Exclusion criteria

• Alternative diagnosis that better explain their symptoms
• Previous elbow trauma or surgery
• Case involving workplace insurance claims (e.g. WSIB)
• Unwilling, or unlikely in the opinion of the investigator to be followed for the duration of the study (e.g., patient refusal, unfixed address, plans to move...etc.)
• Cognitive difficulties that prevent ability to provide informed consent and reliable completion of questionnaires
• Bilateral lateral epicondylitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Arthroscopic tennis elbow release

Active Comparator group

Description:

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

Treatment:

Procedure: Arthroscopic tennis elbow release

Non Operative

Placebo Comparator group

Description:

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

Treatment:

Procedure: Non operative