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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
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Procedure: Non operative Procedure: Arthroscopic tennis elbow release Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients eligible for inclusion in the study will have had symptoms for at least 9 months and have failed conservative management.

Exclusion Criteria:

  • Significant prior elbow trauma will be excluded alternative diagnoses that better explain their symptoms
  • Patients who have had significant prior elbow trauma or surgery
  • WSIB patients

Information from the National Library of Medicine

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


Contacts
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Contact: J W Pollock, MD 613-737-8899 ext 73031
Contact: Katie McIlquham 613-737-8899 ext 79839

Locations
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Canada, Ontario
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         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: J W Pollock, MD The Ottawa Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02236689    
Other Study ID Numbers: 20140553-01H
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries