Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.

Detailed Description
-----------------
This study aims to determine if active external rotation two years postoperatively varies based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty (RTSA). The study also aims to determine whether active forward elevation, abduction, scapular notching, and functional outcomes two years postoperatively vary based on whether an inlay or onlay humeral component is used in reverse shoulder arthroplasty. Patients undergoing primary RTSA by Dr. J. Michael Wiater, Dr. Brett Wiater, or Dr. Alexander Martusiewicz at Beaumont Health will be screened for eligibility. Following informed consent, participants will be randomised (1:1) to one of the following groups: 1) RTSA with inlay humeral component (Tornier Perform Stem Reverse+) or 2) RTSA with onlay humeral component (Tornier Ascend Flex stem). At baseline, participants will complete study questionnaires, receive a range-of-motion (ROM) exam, and standard of care x-rays and computed tomography (CT) scans. These evaluations will be repeated at 3 months, 12 months and 24 months.

Official Title
-----------------
Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty: A Prospective, Randomized Trial

Conditions
-----------------
Arthritis Shoulder, Rotator Cuff Injuries

Intervention / Treatment
-----------------
* Device: Tornier Ascend Flex stem
* Device: Tornier Perform Stem Reverse+


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing primary reverse total shoulder arthroplasty with the following components: Onlay group: Ascend Flex stem, Perform Reversed standard +3 lateralized 25mm baseplate with standard 36 mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere Inlay group: Perform Stem Reverse, Perform Reversed +3 lateralized 25mm baseplate with standard 36mm glenosphere or +6 lateralized 25mm baseplate with 39mm glenosphere Diagnosis of cuff tear arthropathy, massive cuff tear, or primary osteoarthritis with cuff tear Negative external rotation lag sign, ability to externally rotate beyond neutral Age 18 years or older Exclusion Criteria: Revision arthroplasty Prior open shoulder surgery Concomitant tendon transfer (Latissimus Dorsi, Pectoralis Tendon, Lower Trapezius) Diagnosis of rheumatoid arthritis, infection, acute trauma or instability Patients not undergoing a standardized physical therapy protocol Patient anatomy does not accommodate the study implants per surgeon discretion Pregnant, patient-reported Minors (under 18 years of age) Cognitively impaired based on a diagnosis of dementia, psychiatric disorder, or any cognitive deficit that will not allow for proper informed consent or answering of study questionnaires

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized double-blind trial of two active comparators.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Onlay Component-Tornier Ascend Flex stem<br>Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus) | Device: Tornier Ascend Flex stem<br>* Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)<br>|
| Active Comparator: Inlay Component-Tornier Perform Stem Reverse+<br>Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus) | Device: Tornier Perform Stem Reverse+<br>* Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active external rotation, 2 years | Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees. | 2 years postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active external rotation, 3 months | Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees. | 3 months postoperative | 
| Active external rotation, 1 year | Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees. | 1 year postoperative | 
| Strength during active external rotation, 3 months | Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds. | 3 months postoperative | 
| Strength during active external rotation, 1 year | Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds. | 1 year postoperative | 
| Strength during active external rotation, 2 years | Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds | 2 years postoperative | 
| Active forward elevation, 3 months | Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees. | 3 months postoperative | 
| Active forward elevation, 1 year | Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees. | 1 year postoperative | 
| Active forward elevation, 2 years | Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees. | 2 years postoperative | 
| Strength during active forward elevation, 3 months | Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds. | 3 months postoperative | 
| Strength during active forward elevation, 1 year | Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds. | 1 year postoperative | 
| Strength during active forward elevation, 2 years | Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds. | 2 years postoperative | 
| Abduction, 3 months | Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees. | 3 months postoperative | 
| Abduction, 1 year | Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees. | 1 year postoperative | 
| Abduction, 2 years | Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees. | 2 years postoperative | 
| Strength during abduction, 3 months | Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds. | 3 months postoperative | 
| Strength during abduction, 1 year | Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds. | 1 year postoperative | 
| Strength during abduction, 2 years | Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds. | 2 years postoperative | 
| Internal rotation, 3 months | Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees. | 3 months postoperative | 
| Internal rotation, 1 year | Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees. | 1 year postoperative | 
| Internal rotation, 2 years | Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees. | 2 years postoperative | 
| Strength during Internal rotation, 3 months | Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds. | 3 months postoperative | 
| Strength during Internal rotation, 1 year | Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds. | 1 year postoperative | 
| Strength during Internal rotation, 2 years | Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds. | 2 years postoperative | 
| External rotation lag sign test, 3 months | Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness. | 3 months postoperative | 
| External rotation lag sign test, 1 year | Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally. A positive test indicates supraspinatus and infraspinatus tendon weakness. | 1 year postoperative | 
| External rotation lag sign test, 2 years | Number of patients with positive external rotation lag sign test. The test is performed with the elbow passively flexed and repaired shoulder abducted 90 degrees by the examiner. Next, the examiner passively takes the patient's shoulder into a position of maximal external rotation. The patient is then instructed to hold that position. A positive test is if the patient cannot maintain the position and the shoulder rotates internally A positive test indicates supraspinatus and infraspinatus tendon weakness. | 2 years postoperative | 
| Drop arm test, 3 months | Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction. | 3 months postoperative | 
| Drop arm test, 1 year | Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction. | 1 year postoperative | 
| Drop arm test, 2 years | Number of patients with positive drop arm test of repaired shoulder, performed by passively abducting the patient's shoulder and observing for arm drop as the patient slowly lowers the arm to the waist. A positive test indicates supraspinatus dysfunction. | 2 years postoperative | 
| Lift off test, 3 months | Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness. | 3 months postoperative | 
| Lift off test, 1 year | Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness. | 1 year postoperative | 
| Lift off test, 2 years | Number of patients with positive lift off test. The test is performed by the patient performing internal rotation of repaired shoulder, by lifting the hand off the back while the examiner places pressure on the hand. The test is considered to be positive if the patient cannot resist, lift the hand off the back or if the patient compensates by extending the elbow and shoulder. A positive test indicates subscapularis weakness. | 2 years postoperative | 
| Belly press test, 3 months | Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction. | 3 months postoperative | 
| Belly press test, 1 year | Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction. | 1 year postoperative | 
| Belly press test, 2 years | Number of patients with positive belly press test. The patient is asked to press the palm of the hand against the abdomen and bring the elbow forward. The test is positive if the patient is unable to maintain maximal internal rotation of repaired shoulder, demonstrates weakness or the elbow deviates posteriorly. A positive test indicates subscapularis muscle dysfunction. | 2 years postoperative | 
| Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 3 months | Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome). | 3 months postoperative | 
| Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 1 year | Patients will complete a questionnaire of the repaired shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome). | 1 year postoperative | 
| Functional impairment by American Shoulder and Elbow Surgeons' score (ASES), 2 years | Patients will complete a questionnaire of shoulder function and pain, with 100 maximum points. A score of 0 indicates no impairment (best outcome), and 100 indicates maximum impairment (worst outcome). | 2 years postoperative | 
| Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 3 months | Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome). | 3 months postoperative | 
| Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 1 year | Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome). | 1 year postoperative | 
| Quality of life by Western Ontario Osteoarthritis of the Shoulder score (WOOS), 2 years | Patients complete a questionnaire comprising 4 domains of: physical symptoms; sports, recreation and work; lifestyle; and emotions. Each question is answered using a visual analog scale with a possible score ranging from 0 to 100. There are 19 questions, and the total score ranges from 0 to 1900. A score of 1900 signifies that the patient has an extreme decrease in the shoulder-related quality of life (worst outcome), whereas a score of 0 signifies that the patient has no decrease in shoulder-related quality of life (best outcome). | 2 years postoperative | 
| Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 3 months | Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome). | 3 months postoperative | 
| Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 1 year | Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome). | 1 year postoperative | 
| Global Health, by Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) score, 2 years | Patients will complete the PROMIS-10 assessment of global health for the previous 7 days, a 10-question assessment where each statement is scored from 1 (poor health) to 5 (excellent health) on a Likert scale. A total score is summed from the 10 questions, resulting in a minimum of 10 and maximum of 50 points. Higher scores indicate better health (best outcome). | 2 years postoperative | 
| Visual Analog Scale measure of pain, 3 months | Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome). | 3 months postoperative | 
| Visual Analog Scale measure of pain, 1 year | Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome). | 1 year postoperative | 
| Visual Analog Scale measure of pain, 2 years | Shoulder-related pain reported by the patient for the repaired shoulder as a score on a visual analog scale from 0 to 10, where 0=no pain at all (best outcome), and 10=pain as bad as it can be (worst outcome). | 2 years postoperative | 
| Scapular notching, 3 months | Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome). | 3 months postoperative | 
| Scapular notching, 1 year | Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome). | 1 year postoperative | 
| Scapular notching, 2 years | Scapular notching of the repaired shoulder. Measured from radiographic evaluation and scored on the Sirveaux classification scale as Grade 1-4, where grade 1 indicates a defect that only involves the inferior pillar of the scapular neck (best outcome). In Grade 2, the notch contacts the lower screw. In Grade 3, erosion of the bone extends over the lower screw. In Grade 4, the notch extends under the baseplate (worst outcome). | 2 years postoperative | 
| Reoperation | Number of patients requiring reoperation of the same shoulder within 2 years. | 2 years postoperative | 
| Study-related adverse events | All adverse events determined by the PI to be probably or definitely related to study interventions (surgery or device). | 2 years postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder function, shoulder pain, shoulder range of motion