Trial Outcomes & Findings for Arthrex Eclipse™ Shoulder Prosthesis (NCT NCT01790113)
NCT ID: NCT01790113
Last Updated: 2021-02-03
Results Overview
To be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is \> or = to 10 and a final Adjusted Constant Score \> or + to 54. 2. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. 3. No reoperation, removal or modification of any study component up to the subject's completion of the study. 4. No serious device-related complications up to the subject's completion of the study.
TERMINATED
NA
303 participants
2 year
2021-02-03
Participant Flow
In February 2013, the first subject was enrolled in the study and the last subject was enrolled in August 2018. Subjects were enrolled at both academic and private study sites.
The treated population was 303 subject, with 224 Eclipse subjects and 79 Univers II subjects.
Participant milestones
| Measure |
Univers™ II
Univers™ II Total Shoulder Replacement
Univers™: Control
|
Eclipse™
Eclipse™ Total Shoulder Replacement
Eclipse™ Total Shoulder Replacement: Investigational
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
224
|
|
Overall Study
COMPLETED
|
76
|
149
|
|
Overall Study
NOT COMPLETED
|
3
|
75
|
Reasons for withdrawal
| Measure |
Univers™ II
Univers™ II Total Shoulder Replacement
Univers™: Control
|
Eclipse™
Eclipse™ Total Shoulder Replacement
Eclipse™ Total Shoulder Replacement: Investigational
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
7
|
|
Overall Study
Study ended due to FDA clearance
|
1
|
68
|
Baseline Characteristics
Arthrex Eclipse™ Shoulder Prosthesis
Baseline characteristics by cohort
| Measure |
Active Comparator: Univer II
n=79 Participants
Univer II Total Shoulder Replacement
|
Experimental: Eclipse
n=224 Participants
Eclipse Total shoulder Replacement
|
Total
n=303 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
79 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
79 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearTo be considered a success, the eclipse subject must meet the following composite clinical success criteria: 1. An improvement in the Adjusted Constant Score (for pain, Function, and range of motion) from baseline (pre-op) to the 24 month time-point that is \> or = to 10 and a final Adjusted Constant Score \> or + to 54. 2. Radiographic success at the Month 24 time-point which is defined as absence of clinically significant humeral radiolucency, humeral migration/subsidence (relative to 3 month time-point), glenoid migration/subsidence (relative to the 3 month time-point), device disassembly or fracture, and/or periprosthetic fracture, as described in the radiographic protocol. 3. No reoperation, removal or modification of any study component up to the subject's completion of the study. 4. No serious device-related complications up to the subject's completion of the study.
Outcome measures
| Measure |
Univer™ II
n=61 Participants
Univers™ II Total Shoulder Replacement
Univers™: Control
|
Eclipse™
n=132 Participants
Eclipse™ Total Shoulder Replacement
Eclipse™ Total Shoulder Replacement: Investigational
|
|---|---|---|
|
Composite Clinical Success
|
89.7 percentage of success rate
|
92.3 percentage of success rate
|
Adverse Events
Active Comparator: Univer II
Experimental: Eclipse
Serious adverse events
| Measure |
Active Comparator: Univer II
n=79 participants at risk
Univer II Total Shoulder Replacement
|
Experimental: Eclipse
n=224 participants at risk
Eclipse Total shoulder Replacement
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Device -Related SAE
|
0.00%
0/79 • 24 months
|
0.89%
2/224 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Procedure Related
|
2.5%
2/79 • Number of events 2 • 24 months
|
2.7%
6/224 • Number of events 7 • 24 months
|
|
General disorders
Non device /procedure related SAE
|
12.7%
10/79 • Number of events 12 • 24 months
|
8.0%
18/224 • Number of events 21 • 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.00%
0/224 • 24 months
|
|
Blood and lymphatic system disorders
Abnormal Blood levels
|
0.00%
0/79 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Blood Cancer
|
0.00%
0/79 • 24 months
|
0.89%
2/224 • Number of events 2 • 24 months
|
|
Cardiac disorders
Cardia Arrest
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.00%
0/224 • 24 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/79 • 24 months
|
0.89%
2/224 • Number of events 2 • 24 months
|
|
Cardiac disorders
Bradycardia
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.00%
0/224 • 24 months
|
|
Endocrine disorders
Cushing
|
0.00%
0/79 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
abdominal Pain
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/79 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
gastric obstruction
|
0.00%
0/79 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
|
General disorders
Cancer
|
3.8%
3/79 • Number of events 3 • 24 months
|
0.45%
1/224 • Number of events 1 • 24 months
|
|
Infections and infestations
UTI
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.89%
2/224 • Number of events 2 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.8%
3/79 • Number of events 3 • 24 months
|
3.6%
8/224 • Number of events 8 • 24 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/79 • 24 months
|
0.89%
2/224 • Number of events 2 • 24 months
|
|
Renal and urinary disorders
Urinary retention
|
3.8%
3/79 • Number of events 3 • 24 months
|
0.00%
0/224 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.00%
0/224 • 24 months
|
|
Blood and lymphatic system disorders
Venous thrombosis
|
1.3%
1/79 • Number of events 2 • 24 months
|
0.00%
0/224 • 24 months
|
|
Vascular disorders
CVA
|
1.3%
1/79 • Number of events 1 • 24 months
|
0.00%
0/224 • 24 months
|
Other adverse events
| Measure |
Active Comparator: Univer II
n=79 participants at risk
Univer II Total Shoulder Replacement
|
Experimental: Eclipse
n=224 participants at risk
Eclipse Total shoulder Replacement
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
17.7%
14/79 • Number of events 16 • 24 months
|
4.9%
11/224 • Number of events 11 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
11.4%
9/79 • Number of events 11 • 24 months
|
5.8%
13/224 • Number of events 16 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
17.7%
14/79 • Number of events 17 • 24 months
|
12.1%
27/224 • Number of events 34 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.3%
5/79 • Number of events 5 • 24 months
|
1.3%
3/224 • Number of events 3 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place