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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)
Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)
William Beaumont Hospital
Royal Oak, Michigan, United States
Active external rotation, 2 years
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Time frame: 2 years postoperative
Active external rotation, 3 months
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Time frame: 3 months postoperative
Active external rotation, 1 year
Range of motion of repaired shoulder, active external rotation. Measured with goniometer in degrees.
Time frame: 1 year postoperative
Strength during active external rotation, 3 months
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 3 months postoperative
Strength during active external rotation, 1 year
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 1 year postoperative
Strength during active external rotation, 2 years
Strength measurement during active external rotation of repaired shoulder. Measured with dynamometer in pounds
Time frame: 2 years postoperative
Active forward elevation, 3 months
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Time frame: 3 months postoperative
Active forward elevation, 1 year
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Time frame: 1 year postoperative
Active forward elevation, 2 years
Range of motion of repaired shoulder, active forward elevation. Measured with goniometer in degrees.
Time frame: 2 years postoperative
Strength during active forward elevation, 3 months
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 3 months postoperative
Strength during active forward elevation, 1 year
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 1 year postoperative
Strength during active forward elevation, 2 years
Strength measured during active forward elevation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 2 years postoperative
Abduction, 3 months
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Time frame: 3 months postoperative
Abduction, 1 year
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Time frame: 1 year postoperative
Abduction, 2 years
Range of motion of repaired shoulder, abduction. Measured with goniometer in degrees.
Time frame: 2 years postoperative
Strength during abduction, 3 months
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 3 months postoperative
Strength during abduction, 1 year
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 1 year postoperative
Strength during abduction, 2 years
Strength measured during abduction of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 2 years postoperative
Internal rotation, 3 months
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Time frame: 3 months postoperative
Internal rotation, 1 year
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Time frame: 1 year postoperative
Internal rotation, 2 years
Range of motion of repaired shoulder, internal rotation. Measured with goniometer in degrees.
Time frame: 2 years postoperative
Strength during Internal rotation, 3 months
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 3 months postoperative
Strength during Internal rotation, 1 year
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 1 year postoperative
Strength during Internal rotation, 2 years
Strength measured during internal rotation of repaired shoulder. Measured with dynamometer in pounds.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 2 years postoperative
Reoperation
Number of patients requiring reoperation of the same shoulder within 2 years.
Time frame: 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).
Time frame: 2 years postoperative
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