Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02236689|
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : April 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tennis Elbow||Procedure: Non operative Procedure: Arthroscopic tennis elbow release||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind Controlled Trial Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement for the Management of Chronic Lateral Epicondylitis|
|Actual Study Start Date :||April 2016|
|Estimated Primary Completion Date :||June 2025|
|Estimated Study Completion Date :||December 2025|
Active Comparator: Arthroscopic tennis elbow release
This group will have arthroscopic tennis elbow release through a standard, two-portal technique,
Procedure: Arthroscopic tennis elbow release
Patients randomized to Arthroscopic tennis elbow release (ATER) will receive arthroscopic release of the origin of the extensor carpi radialis brevis tendon through a standard, two-portal arthroscopic technique (medial and lateral).
Placebo Comparator: Non Operative
control group will not undergo a second portal or muscle release.
Procedure: Non operative
no surgical intervention
- Change in Mayo Elbow Performance Score [ Time Frame: From baseline to up until 24-Months Post-Operative ]The Mayo Elbow Performance score is an outcome measure specific to the elbow to assess activities of daily living (ADLs). This outcome measure consists of 4 subscales: pain, range of motion, stability and daily function. Each section is combined for a total score out of 100 points. A higher score, indicates a better outcome.
- Change in Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: From baseline to up until 24-Months Post-Operative ]The Disabilities of the Arm, Shoulder and Hand (DASH), is a questionnaire that measures physical function and symptoms in those with an upper extremity disorder. The DASH is a 30 item questionnaire, each question is rated using a Likert scale. The question points are combined for a total of 100 points. A higher score indicates a worse outcome.
- Change in American Shoulder and Elbow Surgeons Elbow (ASES) [ Time Frame: From baseline to up until 24-Months Post-Operative ]The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
- Change in Oxford Elbow Score (OES) [ Time Frame: From time of enrollment up until 2-years post-operative ]The Oxford Elbow Score (OES) is an outcome measure specific to patients who have had elbow surgery. The OES consists of 12 questions, looking into 3 domains: elbow function, pain, and social-psychological, using a Likert scale. Questions are summed, for a total score of 100 points. A higher score indicates a better outcome.
- Change in Grip Strength [ Time Frame: From time of enrollment up until 2-years post-operative ]Grip strength will be measured using a hand-held dynamometer. Each participant will be asked to squeeze as much as they are comfortably able for approximately 3 seconds. 3 trials will be completed on each hand. Results will be averaged, and recorded in kilograms. Higher strength is a better outcome.
- Adverse Events [ Time Frame: Ongoing from time of enrollment, up until 24-months post-operative ]Rates of study adverse events or serious adverse events (e.g. number of reoperations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236689
|Contact: J W Pollock, MD||613-737-8899 ext 73031|
|Contact: Katie McIlquham||613-737-8899 ext 79839|
|The Ottawa Hospital, General Campus||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: J Pollock, MD 613-737-8899 ext 73031|
|Principal Investigator: J W Pollock, MD|
|Principal Investigator:||J W Pollock, MD||The Ottawa Hospital|