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| Name | Class |
|---|---|
| Canadian Orthopaedic Foundation | OTHER |
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Very large tears of the shoulder tendons (the 'rotator cuff') that are not surgically repairable and in the absence of significant shoulder arthritis are common in older patients, and are associated with significant pain and functional limitations. Transfer of one particular tendon called the trapezius is becoming popular as a means of restoring function and improving pain in patients with massive rotator cuff tears. This tendon is appealing for transfer, as it has a similar line of pull to the infraspinatus (one of the rotator cuff tendons). There is currently no clear surgical consensus regarding the optimal treatment of patients with symptomatic massive irreparable rotator cuff tears that are appropriate candidates for joint salvage treatment, and no high level of evidence studies to guide clinical decision making have been published.
A pilot study is required prior to the development of a full-scale trial to assess its feasibility and recruitment across clinical sites, to determine protocol adherence (errors in randomization), and patient retention over a 12-month period.
The main objective of this pilot trial is to assess a composite measure of feasibility including recruitment, protocol adherence, and patient retention at one-year. The secondary objectives, currently exploratory only, are to determine the clinical outcomes of lower trapezius tendon transfer versus arthroscopic rotator cuff partial repair and biceps tenodesis/tenotomy on clinical outcome measures, shoulder function, adverse events and reoperation rates at two-years.
This pilot study is a parallel-group multicentre randomized controlled trial with participating sites across Canada, and one site in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Trapezius Tendon Transfer | Active Comparator | The Lower Trapezius Tendon Transfer procedure involves transferring one of the other tendons located just outside the shoulder (the 'lower trapezius') and attaching this to the upper part of the arm bone, in the place of the torn rotator cuff tendon. |
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| Partial Rotator Cuff Repair | Active Comparator | The rotator cuff repair procedure involves reattaching the torn tendon(s) back to the upper part of the arm bone. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower Trapezius Tendon Transfer | Procedure | This procedure is performed arthroscopically. The lower trapezius tendon is harvested from the back of the shoulder blade. A donor tendon is then used to extend the lower trapezius tendon so that it can reach the top of the arm bone. The tendon graft is then attached to the top of the arm bone, while the other end remains attached to the lower trapezius tendon itself. Any additional concomitant procedures (e.g. debridement, biceps release…etc.) may be performed as well. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment and Follow-Up | Assess the feasibility of this pilot trial as determined by: (1) Recruitment rate of 6 per month across study centres; (2) 3 or fewer crossovers for enrolled participants; and (3) 85% of participants have a full adherence to protocol. | 1-year |
| Measure | Description | Time Frame |
|---|---|---|
| The Western Ontario Rotator Cuff Score (WORC) | The WORC is a disease specific evaluation, proven to be an accurate and valid assessment of quality of life for rotator cuff disease. The WORC is a patient-reported measure, 21-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean a worse outcome. | 2-years post-operative |
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Inclusion Criteria:
Adult male and females over 18 years of age
MRI confirmed diagnosis of massive rotator cuff tears defined using the Schumaier 2020 definition of massive cuff tears which includes the following criteria:
Features of irreparability of their rotator cuff tendon tear including:
An external rotation lag present on clinical exam. A positive external rotation lag will be considered as inability to perform external rotation with or against gravity.
Provision of informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie McIlquham | Contact | 613-737-8899 | 79839 | kmcilquham@ohri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Peter Lapner, MD FRCSC | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
Individual participant data will be be shared with other researchers unless requested and an agreement is in place. Only aggregate data will be made public (overall study results).
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| Partial Rotator Cuff Repair | Procedure | This procedure is performed arthroscopically. The massive rotator cuff tear will be repaired by securing the loose tendon ends to the bone with suture anchors. The surgeon may also conduct a debridement of the area to remove any broken-down cartilage and tissues. Finally, the biceps tendon in will be further inspected for any damage or inflammatory changes, and the tendon may be released at the discretion of the surgeon (known as a biceps tenodesis or tenotomy depending on technique). |
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| Constant Score | The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points. The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome). | 2-years post-operative |
| American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (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. | 2-years post-operative |
| Subjective Shoulder Value | A participant's subjective value on shoulder function will be assessed using a questionnaire. The overall functional value of the shoulder is written as a percentage from 0-100% of a normal shoulder. The higher the score, the better the outcome. | 2-years post-operative |
| EuroQol EQ-5D-5L | The EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (each question rated 1-5), lower scores indicate better outcome. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100), where a higher score indicates a better outcome. | 2-years post-operative |
| Functional Range of Motion | Measured in degrees, and active movement. Range of motion measures include forward elevation (flexion), abduction, and external rotation from a neutral position, and internal rotation at the spinal level. | 2-years post-operative |
| Strength | Measured using a dynamometer, and from the external rotation in neutral position. Strength will be reported in pounds. | 2-years post-operative |
| Ultrasound | Ultrasound will be used to evaluate tendon healing rate after the repair or the transfer and assess for integrity. If the repair/transfer has healed it is considered a better outcome (tendon healing - yes/no). | 1-year post-operative |
| Reoperation Rate | The number of reoperations will be monitored and recorded and compared between study groups. A higher rate of reoperations indicates a worse outcome. | 2-years post-operative |