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Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement

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ClinicalTrials.gov Identifier: NCT02236689
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
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, with arthroscopy gaining 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. 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 answer this question and provide better recommendations for the use of this procedure.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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
Study Start Date : April 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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. Mayo Elbow Performance Score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand [ Time Frame: 1 year ]
  2. American Shoulder and Elbow Surgeons Elbow [ Time Frame: 1 year ]


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 1 year and have failed conservative management.

Exclusion Criteria:

  • Significant prior elbow trauma will be excluded alternative diagnoses that better explain their symptoms (ie. golfer's elbow)

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

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     History of Changes
Other Study ID Numbers: 2014-0553
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries