Clinical trial NCT02236689: Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement
Official title: A Randomized, Double-blind Controlled Trial Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement for the Management of Chronic Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tennis Elbow
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mayo Elbow Performance Score
timeFrame: From baseline to up until 24-Months Post-Operative
Secondary outcomes:
measure: Change in Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: From baseline to up until 24-Months Post-Operative
measure: Change in American Shoulder and Elbow Surgeons Elbow (ASES)
timeFrame: From baseline to up until 24-Months Post-Operative
measure: Change in Oxford Elbow Score (OES)
timeFrame: From time of enrollment up until 2-years post-operative
measure: Change in Grip Strength
timeFrame: From time of enrollment up until 2-years post-operative
measure: Adverse Events
timeFrame: Ongoing from time of enrollment, up until 24-months post-operative
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: J W Pollock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matache BA, Berdusco R, Momoli F, Lapner PL, Pollock JW. A randomized, double-blind sham-controlled trial on the efficacy of arthroscopic tennis elbow release for the management of chronic lateral epicondylitis. BMC Musculoskelet Disord. 2016 Jun 1;17:239. doi: 10.1186/s12891-016-1093-9.