Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement
Primary Purpose
Tennis Elbow
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Non operative
Arthroscopic tennis elbow release
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow
Eligibility 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
Sites / Locations
- The Ottawa Hospital, General CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Arthroscopic tennis elbow release
Non Operative
Arm Description
This group will have arthroscopic tennis elbow release through a standard, two-portal technique,
control group will not undergo a second portal or muscle release.
Outcomes
Primary Outcome Measures
Change in Mayo Elbow Performance Score
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
Change in Disabilities of the Arm, Shoulder and Hand (DASH)
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)
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)
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
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
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.
Full Information
NCT ID
NCT02236689
First Posted
September 8, 2014
Last Updated
September 21, 2022
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02236689
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arthroscopic tennis elbow release
Arm Type
Active Comparator
Arm Description
This group will have arthroscopic tennis elbow release through a standard, two-portal technique,
Arm Title
Non Operative
Arm Type
Placebo Comparator
Arm Description
control group will not undergo a second portal or muscle release.
Intervention Type
Procedure
Intervention Name(s)
Non operative
Intervention Description
no surgical intervention
Intervention Type
Procedure
Intervention Name(s)
Arthroscopic tennis elbow release
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Mayo Elbow Performance Score
Description
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.
Time Frame
From baseline to up until 24-Months Post-Operative
Secondary Outcome Measure Information:
Title
Change in Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
From baseline to up until 24-Months Post-Operative
Title
Change in American Shoulder and Elbow Surgeons Elbow (ASES)
Description
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.
Time Frame
From baseline to up until 24-Months Post-Operative
Title
Change in Oxford Elbow Score (OES)
Description
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.
Time Frame
From time of enrollment up until 2-years post-operative
Title
Change in Grip Strength
Description
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.
Time Frame
From time of enrollment up until 2-years post-operative
Title
Adverse Events
Description
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.
Time Frame
Ongoing from time of enrollment, up until 24-months post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
J W Pollock, MD
Phone
613-737-8899
Ext
73031
First Name & Middle Initial & Last Name or Official Title & Degree
Katie McIlquham
Phone
613-737-8899
Ext
79839
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J W Pollock, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital, General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Pollock, MD
Phone
613-737-8899
Ext
73031
First Name & Middle Initial & Last Name & Degree
J W Pollock, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27245219
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.
Results Reference
derived
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Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement
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