Glenohumeral Joint Degeneration
Conditions
Brief summary
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.
Interventions
DEVICEReUnion System with a Large-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
DEVICEReUnion System with a Small-Diameter Glenosphere +2 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
DEVICEReUnion System with a Large-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
DEVICEReUnion System with a Small-Diameter Glenosphere +6 mm offset
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
Sponsors
Stryker Nordic
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects willing to sign the informed consent * Male and non-pregnant female subjects ages 50 - 90 at the time of surgery * Subjects requiring a primary reverse total shoulder arthroplasty * Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss
Exclusion criteria
* Inability to comply with follow-up requirements * Subjects with inflammatory arthritis * Subjects with proximal humerus fractures * Subjects with sequels of trauma * Subjects that are immunologically compromised * Subjects with an active or suspected latent infection in or about the shoulder * Need to add a tendon transfer * Need for structural humeral bone graft * Pregnant subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Active Forward Elevation of the Shoulder | One year | Degrees of movement the participant is able to independently lift arm upward to the ceiling, while keeping elbow straight. Normal movement for forward elevation is 180 degrees. |
| Active External Rotation of the Shoulder | One year | Degrees of movement the participant is able to independently rotate arm up, while keeping arm at 0 degrees of abduction. Normal movement for external rotation is 90 degrees. |
| Shoulder Abduction Strength | one year | Shoulder abduction strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal. |
| Shoulder External Rotation Strength | One year | Shoulder external rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal. |
| Shoulder Internal Rotation Strength | One year | Shoulder internal rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Shoulder Score (OSS) Questionnaire | 1 year | The Oxford Shoulder Score (OSS) is a patient reported questionnaire that includes 12 descriptors of pain and disability for shoulder ailments and related quality of daily activities. Each descriptor rating ranges from 0 to 4, with 4 representing the best (no pain, no difficulty with activity) and 0 is the worst (unbearable pain, extreme difficulty with activity). The score is calculated from the summation of all 12 descriptors, for a total range of 0 to 48, where a higher score reflects the best outcome (less pain and difficulty with activity) and a lower score reflects a worse outcome (more pain and difficulty with activity). |
| American Shoulder and Elbow Surgeons (ASES) Questionnaire | One year | A self-assessment that measures pain and ability to perform daily activities.The questionnaire is divided into 2 components, a single pain question and 10 questions on function of daily living.The total score is weighted 50% for pain and 50% for function. Pain is ranked from 0-10, where 0 is no pain and 10 is unbearable pain.The total pain score is calculated by subtracting the result of this question from 10 and multiplying by 5.The function score is calculated from the sum of 10 questions on daily living.The 10 questions are scored from 0-3, where 0=unable to perform daily activity and 3=no difficulty with daily activity.The individual function scores are summed for a maximum functional score of 30.This functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points.The pain and function scores are then added together to obtain the final score out of 100.The final score ranges from 0 to 100, where higher scores correlate to better outcomes. |
| Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire | One year | The Quick DASH (disabilities of the arm, shoulder and hand) questionnaire is an 11 item self-reported participant questionnaire that measures physical function and symptoms in individuals experiencing musculoskeletal disorders of the upper limb. Each item is scored 1-5 where 1 reflects no pain or difficulty with activities and 5 reflects extreme pain or difficulty with activities. All individual scores are then summed and averaged to produce a score out of five. The score is then transformed to a score out of 100 by subtracting one and multiplying by 25. The final score ranges from 0 to 100, where a higher resulting score reflects more pain and greater disability while a lower score reflects less pain and disability. |
| Shoulder Pain | One year | Shoulder pain values reported by participants will be assessed using the 10cm Visual Analogue Scale (VAS). The VAS line will be 10 cm long with two endpoints representing 0 (no pain) and 10 (worst possible pain). Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the No pain end, and the number of centimeters will be reported as the pain score. |
| Patient Satisfaction | One year | Patient satisfaction with the outcome of the surgery measured by on a scale from 1-10, where 1 is not at all satisfied and 10 is very satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Small-Diameter Glenosphere +2 mm Offset Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
ReUnion System with a Small-Diameter Glenosphere +2 mm offset: Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset | 34 |
| Small-Diameter Glenosphere +6 mm Offset Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
ReUnion System with a Small-Diameter Glenosphere +6 mm offset: Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset | 28 |
| Large-Diameter Glenosphere +2 mm Offset Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
ReUnion System with a Large-Diameter Glenosphere +2 mm offset: Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset | 29 |
| Large-Diameter Glenosphere +6 mm Offset Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
ReUnion System with a Large-Diameter Glenosphere +6 mm offset: Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset | 22 |
| Total | 113 |
Baseline characteristics
| Characteristic | Small-Diameter Glenosphere +6 mm Offset | Large-Diameter Glenosphere +2 mm Offset | Large-Diameter Glenosphere +6 mm Offset | Total | Small-Diameter Glenosphere +2 mm Offset |
|---|---|---|---|---|---|
| Age, Continuous | 72.90 years STANDARD_DEVIATION 7.92 | 73.75 years STANDARD_DEVIATION 7.2 | 71.98 years STANDARD_DEVIATION 7.72 | 72.3 years STANDARD_DEVIATION 7.6 | 72.65 years STANDARD_DEVIATION 8.24 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 28 participants | 29 participants | 22 participants | 113 participants | 34 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 8 Participants | 55 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 14 Participants | 58 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 28 | 0 / 29 | 0 / 22 |
| other Total, other adverse events | 0 / 34 | 3 / 28 | 0 / 29 | 0 / 22 |
| serious Total, serious adverse events | 0 / 34 | 5 / 28 | 0 / 29 | 0 / 22 |
Outcome results
Primary
Active External Rotation of the Shoulder
Degrees of movement the participant is able to independently rotate arm up, while keeping arm at 0 degrees of abduction. Normal movement for external rotation is 90 degrees.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Active External Rotation of the Shoulder | 55 degrees of movement | Standard Deviation 17 |
| Small-Diameter Glenosphere +6 mm Offset | Active External Rotation of the Shoulder | 60 degrees of movement | Standard Deviation 18 |
| Large-Diameter Glenosphere +2 mm Offset | Active External Rotation of the Shoulder | 52 degrees of movement | Standard Deviation 22 |
| Large-Diameter Glenosphere +6 mm Offset | Active External Rotation of the Shoulder | 54 degrees of movement | Standard Deviation 17 |
p-value: 0.558ANOVA
Primary
Active Forward Elevation of the Shoulder
Degrees of movement the participant is able to independently lift arm upward to the ceiling, while keeping elbow straight. Normal movement for forward elevation is 180 degrees.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Active Forward Elevation of the Shoulder | 146 degrees of movement | Standard Deviation 15 |
| Small-Diameter Glenosphere +6 mm Offset | Active Forward Elevation of the Shoulder | 141 degrees of movement | Standard Deviation 28 |
| Large-Diameter Glenosphere +2 mm Offset | Active Forward Elevation of the Shoulder | 143 degrees of movement | Standard Deviation 19 |
| Large-Diameter Glenosphere +6 mm Offset | Active Forward Elevation of the Shoulder | 137 degrees of movement | Standard Deviation 20 |
p-value: 0.552ANOVA
Primary
Shoulder Abduction Strength
Shoulder abduction strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Shoulder Abduction Strength | 4.8 units on a scale | Standard Deviation 0.4 |
| Small-Diameter Glenosphere +6 mm Offset | Shoulder Abduction Strength | 4.5 units on a scale | Standard Deviation 0.6 |
| Large-Diameter Glenosphere +2 mm Offset | Shoulder Abduction Strength | 4.7 units on a scale | Standard Deviation 0.5 |
| Large-Diameter Glenosphere +6 mm Offset | Shoulder Abduction Strength | 4.8 units on a scale | Standard Deviation 0.4 |
p-value: 0.274Kruskal-Wallis
Primary
Shoulder External Rotation Strength
Shoulder external rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Shoulder External Rotation Strength | 4.8 units on a scale | Standard Deviation 0.4 |
| Small-Diameter Glenosphere +6 mm Offset | Shoulder External Rotation Strength | 4.6 units on a scale | Standard Deviation 0.6 |
| Large-Diameter Glenosphere +2 mm Offset | Shoulder External Rotation Strength | 4.7 units on a scale | Standard Deviation 0.5 |
| Large-Diameter Glenosphere +6 mm Offset | Shoulder External Rotation Strength | 4.7 units on a scale | Standard Deviation 0.4 |
p-value: 0.539Kruskal-Wallis
Primary
Shoulder Internal Rotation Strength
Shoulder internal rotation strength was measured using manual testing where strength was graded as: (1) paralysis; (2) contraction with no ability to resist gravity; (3) weak but able to resist gravity; (4) weak but able to resist the examiner; (5) normal.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Shoulder Internal Rotation Strength | 4.9 units on a scale | Standard Deviation 0.3 |
| Small-Diameter Glenosphere +6 mm Offset | Shoulder Internal Rotation Strength | 4.8 units on a scale | Standard Deviation 0.4 |
| Large-Diameter Glenosphere +2 mm Offset | Shoulder Internal Rotation Strength | 4.7 units on a scale | Standard Deviation 0.4 |
| Large-Diameter Glenosphere +6 mm Offset | Shoulder Internal Rotation Strength | 4.9 units on a scale | Standard Deviation 0.3 |
p-value: 0.478Kruskal-Wallis
Secondary
American Shoulder and Elbow Surgeons (ASES) Questionnaire
A self-assessment that measures pain and ability to perform daily activities.The questionnaire is divided into 2 components, a single pain question and 10 questions on function of daily living.The total score is weighted 50% for pain and 50% for function. Pain is ranked from 0-10, where 0 is no pain and 10 is unbearable pain.The total pain score is calculated by subtracting the result of this question from 10 and multiplying by 5.The function score is calculated from the sum of 10 questions on daily living.The 10 questions are scored from 0-3, where 0=unable to perform daily activity and 3=no difficulty with daily activity.The individual function scores are summed for a maximum functional score of 30.This functional score is then multiplied by 5/3 to make the maximum functional score out of 50 possible points.The pain and function scores are then added together to obtain the final score out of 100.The final score ranges from 0 to 100, where higher scores correlate to better outcomes.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | American Shoulder and Elbow Surgeons (ASES) Questionnaire | 50.7 score on a scale | Standard Deviation 37.8 |
| Small-Diameter Glenosphere +6 mm Offset | American Shoulder and Elbow Surgeons (ASES) Questionnaire | 46.7 score on a scale | Standard Deviation 39.5 |
| Large-Diameter Glenosphere +2 mm Offset | American Shoulder and Elbow Surgeons (ASES) Questionnaire | 56.8 score on a scale | Standard Deviation 37.6 |
| Large-Diameter Glenosphere +6 mm Offset | American Shoulder and Elbow Surgeons (ASES) Questionnaire | 56.4 score on a scale | Standard Deviation 35.6 |
p-value: 0.823ANOVA
Secondary
Oxford Shoulder Score (OSS) Questionnaire
The Oxford Shoulder Score (OSS) is a patient reported questionnaire that includes 12 descriptors of pain and disability for shoulder ailments and related quality of daily activities. Each descriptor rating ranges from 0 to 4, with 4 representing the best (no pain, no difficulty with activity) and 0 is the worst (unbearable pain, extreme difficulty with activity). The score is calculated from the summation of all 12 descriptors, for a total range of 0 to 48, where a higher score reflects the best outcome (less pain and difficulty with activity) and a lower score reflects a worse outcome (more pain and difficulty with activity).
Time frame: 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Oxford Shoulder Score (OSS) Questionnaire | 6.8 score on a scale | Standard Deviation 14.8 |
| Small-Diameter Glenosphere +6 mm Offset | Oxford Shoulder Score (OSS) Questionnaire | 4.2 score on a scale | Standard Deviation 8.9 |
| Large-Diameter Glenosphere +2 mm Offset | Oxford Shoulder Score (OSS) Questionnaire | 11.0 score on a scale | Standard Deviation 20.4 |
| Large-Diameter Glenosphere +6 mm Offset | Oxford Shoulder Score (OSS) Questionnaire | 0.7 score on a scale | Standard Deviation 0.1 |
p-value: 0.527ANOVA
Secondary
Patient Satisfaction
Patient satisfaction with the outcome of the surgery measured by on a scale from 1-10, where 1 is not at all satisfied and 10 is very satisfied.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Patient Satisfaction | 9.6 score on a scale | Standard Deviation 0.7 |
| Small-Diameter Glenosphere +6 mm Offset | Patient Satisfaction | 9.4 score on a scale | Standard Deviation 1 |
| Large-Diameter Glenosphere +2 mm Offset | Patient Satisfaction | 9.2 score on a scale | Standard Deviation 1.6 |
| Large-Diameter Glenosphere +6 mm Offset | Patient Satisfaction | 9.4 score on a scale | Standard Deviation 0.8 |
p-value: 0.789Kruskal-Wallis
Secondary
Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire
The Quick DASH (disabilities of the arm, shoulder and hand) questionnaire is an 11 item self-reported participant questionnaire that measures physical function and symptoms in individuals experiencing musculoskeletal disorders of the upper limb. Each item is scored 1-5 where 1 reflects no pain or difficulty with activities and 5 reflects extreme pain or difficulty with activities. All individual scores are then summed and averaged to produce a score out of five. The score is then transformed to a score out of 100 by subtracting one and multiplying by 25. The final score ranges from 0 to 100, where a higher resulting score reflects more pain and greater disability while a lower score reflects less pain and disability.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire | 9.7 score on a scale | Standard Deviation 0.6 |
| Small-Diameter Glenosphere +6 mm Offset | Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire | 9.1 score on a scale | Standard Deviation 1.4 |
| Large-Diameter Glenosphere +2 mm Offset | Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire | 9.3 score on a scale | Standard Deviation 1.4 |
| Large-Diameter Glenosphere +6 mm Offset | Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire | 8.3 score on a scale | Standard Deviation 2.1 |
p-value: 0.231ANOVA
Secondary
Shoulder Pain
Shoulder pain values reported by participants will be assessed using the 10cm Visual Analogue Scale (VAS). The VAS line will be 10 cm long with two endpoints representing 0 (no pain) and 10 (worst possible pain). Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the No pain end, and the number of centimeters will be reported as the pain score.
Time frame: One year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Small-Diameter Glenosphere +2 mm Offset | Shoulder Pain | 0.3 score on a scale | Standard Deviation 0.9 |
| Small-Diameter Glenosphere +6 mm Offset | Shoulder Pain | 0.5 score on a scale | Standard Deviation 0.9 |
| Large-Diameter Glenosphere +2 mm Offset | Shoulder Pain | 0.3 score on a scale | Standard Deviation 0.9 |
| Large-Diameter Glenosphere +6 mm Offset | Shoulder Pain | 0.3 score on a scale | Standard Deviation 0.8 |
p-value: 0.595Kruskal-Wallis