Trial Outcomes & Findings for Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty (NCT NCT02768597)
NCT ID: NCT02768597
Last Updated: 2024-02-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
One year
Results posted on
2024-02-13
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
28
|
29
|
22
|
|
Overall Study
COMPLETED
|
34
|
28
|
29
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72.65 years
STANDARD_DEVIATION 8.24 • n=34 Participants
|
72.90 years
STANDARD_DEVIATION 7.92 • n=28 Participants
|
73.75 years
STANDARD_DEVIATION 7.20 • n=29 Participants
|
71.98 years
STANDARD_DEVIATION 7.72 • n=22 Participants
|
72.3 years
STANDARD_DEVIATION 7.6 • n=113 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=34 Participants
|
14 Participants
n=28 Participants
|
15 Participants
n=29 Participants
|
8 Participants
n=22 Participants
|
55 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=34 Participants
|
14 Participants
n=28 Participants
|
14 Participants
n=29 Participants
|
14 Participants
n=22 Participants
|
58 Participants
n=113 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
34 participants
n=34 Participants
|
28 participants
n=28 Participants
|
29 participants
n=29 Participants
|
22 participants
n=22 Participants
|
113 participants
n=113 Participants
|
PRIMARY outcome
Timeframe: One yearDegrees 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Active Forward Elevation of the Shoulder
|
146 degrees of movement
Standard Deviation 15
|
141 degrees of movement
Standard Deviation 28
|
143 degrees of movement
Standard Deviation 19
|
137 degrees of movement
Standard Deviation 20
|
PRIMARY outcome
Timeframe: One yearDegrees 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Active External Rotation of the Shoulder
|
55 degrees of movement
Standard Deviation 17
|
60 degrees of movement
Standard Deviation 18
|
52 degrees of movement
Standard Deviation 22
|
54 degrees of movement
Standard Deviation 17
|
PRIMARY outcome
Timeframe: one yearShoulder 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Shoulder Abduction Strength
|
4.8 units on a scale
Standard Deviation 0.4
|
4.5 units on a scale
Standard Deviation 0.6
|
4.7 units on a scale
Standard Deviation 0.5
|
4.8 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: One yearShoulder 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Shoulder External Rotation Strength
|
4.8 units on a scale
Standard Deviation 0.4
|
4.6 units on a scale
Standard Deviation 0.6
|
4.7 units on a scale
Standard Deviation 0.5
|
4.7 units on a scale
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: One yearShoulder 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Shoulder Internal Rotation Strength
|
4.9 units on a scale
Standard Deviation 0.3
|
4.8 units on a scale
Standard Deviation 0.4
|
4.7 units on a scale
Standard Deviation 0.4
|
4.9 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 1 yearThe 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).
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Oxford Shoulder Score (OSS) Questionnaire
|
6.8 score on a scale
Standard Deviation 14.8
|
4.2 score on a scale
Standard Deviation 8.9
|
11.0 score on a scale
Standard Deviation 20.4
|
0.7 score on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: One yearA 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
American Shoulder and Elbow Surgeons (ASES) Questionnaire
|
50.7 score on a scale
Standard Deviation 37.8
|
46.7 score on a scale
Standard Deviation 39.5
|
56.8 score on a scale
Standard Deviation 37.6
|
56.4 score on a scale
Standard Deviation 35.6
|
SECONDARY outcome
Timeframe: One yearThe 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire
|
9.7 score on a scale
Standard Deviation 0.6
|
9.1 score on a scale
Standard Deviation 1.4
|
9.3 score on a scale
Standard Deviation 1.4
|
8.3 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: One yearShoulder 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Shoulder Pain
|
0.3 score on a scale
Standard Deviation 0.9
|
0.5 score on a scale
Standard Deviation 0.9
|
0.3 score on a scale
Standard Deviation 0.9
|
0.3 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: One yearPatient 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.
Outcome measures
| Measure |
Small-Diameter Glenosphere +2 mm Offset
n=34 Participants
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 Participants
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
|
Large-Diameter Glenosphere +2 mm Offset
n=29 Participants
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 Participants
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
|
|---|---|---|---|---|
|
Patient Satisfaction
|
9.6 score on a scale
Standard Deviation 0.7
|
9.4 score on a scale
Standard Deviation 1.0
|
9.2 score on a scale
Standard Deviation 1.6
|
9.4 score on a scale
Standard Deviation 0.8
|
Adverse Events
Large-Diameter Glenosphere +2 mm Offset
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Large-Diameter Glenosphere +6 mm Offset
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Small-Diameter Glenosphere +2 mm Offset
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Small-Diameter Glenosphere +6 mm Offset
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Large-Diameter Glenosphere +2 mm Offset
n=29 participants at risk
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 participants at risk
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
|
Small-Diameter Glenosphere +2 mm Offset
n=34 participants at risk
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 participants at risk
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
|
|---|---|---|---|---|
|
General disorders
Reoperation
|
0.00%
0/29 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/22 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/34 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
10.7%
3/28 • Number of events 3 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
|
General disorders
Revision surgery
|
0.00%
0/29 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/22 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/34 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
7.1%
2/28 • Number of events 2 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
Other adverse events
| Measure |
Large-Diameter Glenosphere +2 mm Offset
n=29 participants at risk
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
|
Large-Diameter Glenosphere +6 mm Offset
n=22 participants at risk
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
|
Small-Diameter Glenosphere +2 mm Offset
n=34 participants at risk
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
|
Small-Diameter Glenosphere +6 mm Offset
n=28 participants at risk
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
|
|---|---|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/29 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/22 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/34 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
3.6%
1/28 • Number of events 1 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
|
General disorders
Instability requiring modular component exchange
|
0.00%
0/29 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/22 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/34 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
3.6%
1/28 • Number of events 1 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
|
General disorders
Component failure
|
0.00%
0/29 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/22 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
0.00%
0/34 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
3.6%
1/28 • Number of events 1 • Adverse events were collected on all participants from enrollment until approximately two years after surgery, for a total of approximately five years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place