Trial Outcomes & Findings for Reverse Shoulder Prosthesis Study (NCT NCT00764504)
NCT ID: NCT00764504
Last Updated: 2011-04-19
Results Overview
The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: \[(10 - Visual analog scale pain score) x 5\] + \[(5/3) x Cumulative ADL score\]
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
516 participants
Primary outcome timeframe
2-year
Results posted on
2011-04-19
Participant Flow
Participant milestones
| Measure |
Primary
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Overall Study
STARTED
|
141
|
141
|
234
|
|
Overall Study
COMPLETED
|
75
|
71
|
131
|
|
Overall Study
NOT COMPLETED
|
66
|
70
|
103
|
Reasons for withdrawal
| Measure |
Primary
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Overall Study
Death
|
12
|
6
|
13
|
|
Overall Study
Revision of Device
|
12
|
23
|
14
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
40
|
34
|
72
|
Baseline Characteristics
Reverse Shoulder Prosthesis Study
Baseline characteristics by cohort
| Measure |
Primary
n=141 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=141 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=234 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
Total
n=516 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
111 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
377 Participants
n=4 Participants
|
|
Age Continuous
|
71.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
67.4 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
71.2 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
70.4 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
320 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
196 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
141 participants
n=5 Participants
|
141 participants
n=7 Participants
|
234 participants
n=5 Participants
|
516 participants
n=4 Participants
|
|
Operative Shoulder
Right
|
87 participants
n=5 Participants
|
83 participants
n=7 Participants
|
146 participants
n=5 Participants
|
316 participants
n=4 Participants
|
|
Operative Shoulder
Left
|
54 participants
n=5 Participants
|
58 participants
n=7 Participants
|
88 participants
n=5 Participants
|
200 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2-yearPopulation: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
The patient self-report section of the ASES is a condition specific scale which is intended to measure functional limitations and pain of the shoulder. On a scale of 0 to 100, the use of their shoulder is measured with 0 = no use and 100 = full use. The assessment is done in two sections. One Pain (measured by the Visual Analog Pain Scale) and the second is a list of 10 questions referred to as the Activities of Daily Living. The results are calculated with the following equation: \[(10 - Visual analog scale pain score) x 5\] + \[(5/3) x Cumulative ADL score\]
Outcome measures
| Measure |
Primary
n=59 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=49 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=98 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
American Shoulder and Elbow Surgeons Shoulder Score
|
76 Units on a scale
Standard Deviation 18.5
|
62 Units on a scale
Standard Deviation 18.5
|
77 Units on a scale
Standard Deviation 18.1
|
PRIMARY outcome
Timeframe: 2-yearPopulation: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Physician's assessment of a subject's range of motion in degrees.
Outcome measures
| Measure |
Primary
n=59 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=49 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=98 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Average Range of Motion
Active forward elevation
|
119.6 Angle of Degrees of Shoulder Motion
Standard Deviation 39.3
|
84.4 Angle of Degrees of Shoulder Motion
Standard Deviation 36.5
|
120.4 Angle of Degrees of Shoulder Motion
Standard Deviation 34.7
|
|
Average Range of Motion
Active external rotation
|
33.3 Angle of Degrees of Shoulder Motion
Standard Deviation 19.0
|
23.3 Angle of Degrees of Shoulder Motion
Standard Deviation 18.7
|
37.1 Angle of Degrees of Shoulder Motion
Standard Deviation 24.2
|
|
Average Range of Motion
Active cross body adduction
|
25.8 Angle of Degrees of Shoulder Motion
Standard Deviation 18.6
|
13.9 Angle of Degrees of Shoulder Motion
Standard Deviation 15.6
|
27.4 Angle of Degrees of Shoulder Motion
Standard Deviation 20.6
|
PRIMARY outcome
Timeframe: 2-yearPopulation: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Each subject had a chance to rate their satisfaction with surgery at each study interval.
Outcome measures
| Measure |
Primary
n=59 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=49 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=98 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Subject Satisfaction With Surgery
Excellent
|
31 participants
|
20 participants
|
60 participants
|
|
Subject Satisfaction With Surgery
Good
|
18 participants
|
12 participants
|
27 participants
|
|
Subject Satisfaction With Surgery
Satisfactory
|
6 participants
|
13 participants
|
9 participants
|
|
Subject Satisfaction With Surgery
Unsatisfactory
|
4 participants
|
4 participants
|
2 participants
|
PRIMARY outcome
Timeframe: 2-yearPopulation: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
Subject satisfaction: subject's willingness to have surgery performed again if necessary.
Outcome measures
| Measure |
Primary
n=59 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=49 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=98 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Have Surgery Again?
Yes
|
52 participants
|
40 participants
|
88 participants
|
|
Have Surgery Again?
No
|
7 participants
|
9 participants
|
10 participants
|
PRIMARY outcome
Timeframe: 2-yearPopulation: The number of participants analyzed is based on the number of participants who completed the study at the 2 year time frame and who had complete data sets at the final visit.
To meet Neer's limited goals, a subject must report: none, slight or moderate pain with unusual activity and exhibit \>90 degrees active forward elevation and exhibit \>20 degrees of active external rotation.
Outcome measures
| Measure |
Primary
n=59 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=49 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=98 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Neer's "Limited Goals"
Yes - criteria met
|
33 participants
|
9 participants
|
59 participants
|
|
Neer's "Limited Goals"
No - criteria not met
|
26 participants
|
40 participants
|
39 participants
|
PRIMARY outcome
Timeframe: Post-operative, 3-month, 6-month, 1-year, 2-yearPopulation: Number of subjects who came in for a 2 year visit and completed the x-ray portion of the exam.
Radiographic failure is defined as a shift in the position of the component \>3mm or 3 degrees, a fracture of the cement mantle, a fracture of the component, or a \>2mm radiolucency completely around either prosthesis.
Outcome measures
| Measure |
Primary
n=69 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=62 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=127 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Radiographic Failures
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 2-yearPopulation: Adverse events were collected for all subjects who received the RSP device whether or not they were removed from the study at a later date due to protocol violation or consent issues.
Number of device related adverse events and device failures at the 2 year time frame.
Outcome measures
| Measure |
Primary
n=156 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=162 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=249 Participants
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Safety Assessment
Revisions of device
|
12 adverse events
|
23 adverse events
|
14 adverse events
|
|
Safety Assessment
Number of device related adverse events
|
27 adverse events
|
25 adverse events
|
14 adverse events
|
|
Safety Assessment
Total number of operative site adverse events
|
87 adverse events
|
117 adverse events
|
91 adverse events
|
Adverse Events
Primary
Serious events: 0 serious events
Other events: 116 other events
Deaths: 0 deaths
Revision
Serious events: 0 serious events
Other events: 113 other events
Deaths: 0 deaths
Continued Access
Serious events: 0 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Primary
n=156 participants at risk
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder.
|
Revision
n=162 participants at risk
Subjects who are eligible to receive a reverse shoulder prosthesis and who have previously received another orthopedic implant in the operative shoulder. The change in implant device is due to failure of the previously inserted orthopedic device.
|
Continued Access
n=249 participants at risk
Subjects who are eligible to receive a reverse shoulder prosthesis and who have not previously received another orthopedic implant in the operative shoulder. This group are also primary subjects who were enrolled at a later date in order to collect additional data on the reverse shoulder.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia / Bleeding
|
0.64%
1/156 • Number of events 1
|
4.9%
8/162 • Number of events 9
|
0.00%
0/249
|
|
Surgical and medical procedures
Broken Device / Component
|
2.6%
4/156 • Number of events 4
|
1.2%
2/162 • Number of events 2
|
0.00%
0/249
|
|
Surgical and medical procedures
Broken Screw
|
5.8%
9/156 • Number of events 11
|
1.9%
3/162 • Number of events 3
|
0.80%
2/249 • Number of events 2
|
|
Immune system disorders
Cancer
|
3.2%
5/156 • Number of events 5
|
1.9%
3/162 • Number of events 3
|
2.0%
5/249 • Number of events 5
|
|
Social circumstances
Death - Natural Causes
|
5.8%
9/156 • Number of events 9
|
3.1%
5/162 • Number of events 5
|
5.2%
13/249 • Number of events 13
|
|
Surgical and medical procedures
Device Instability / Failure
|
7.1%
11/156 • Number of events 11
|
9.9%
16/162 • Number of events 17
|
3.2%
8/249 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
5.8%
9/156 • Number of events 14
|
13.0%
21/162 • Number of events 25
|
3.6%
9/249 • Number of events 13
|
|
Blood and lymphatic system disorders
Edema
|
3.2%
5/156 • Number of events 5
|
4.3%
7/162 • Number of events 8
|
1.6%
4/249 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
10.3%
16/156 • Number of events 16
|
9.9%
16/162 • Number of events 16
|
8.4%
21/249 • Number of events 23
|
|
Cardiac disorders
Heart Complications
|
6.4%
10/156 • Number of events 11
|
1.9%
3/162 • Number of events 5
|
4.4%
11/249 • Number of events 11
|
|
Infections and infestations
Infections
|
2.6%
4/156 • Number of events 4
|
8.0%
13/162 • Number of events 18
|
6.4%
16/249 • Number of events 17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
36.5%
57/156 • Number of events 81
|
29.0%
47/162 • Number of events 64
|
27.3%
68/249 • Number of events 103
|
|
Nervous system disorders
Neurological disorder and numbness
|
2.6%
4/156 • Number of events 4
|
3.1%
5/162 • Number of events 5
|
3.2%
8/249 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.64%
1/156 • Number of events 1
|
1.9%
3/162 • Number of events 3
|
2.8%
7/249 • Number of events 7
|
|
Vascular disorders
Stroke
|
1.3%
2/156 • Number of events 2
|
0.62%
1/162 • Number of events 1
|
1.6%
4/249 • Number of events 6
|
|
Vascular disorders
Swelling
|
1.9%
3/156 • Number of events 3
|
1.9%
3/162 • Number of events 3
|
2.4%
6/249 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60