Trial Outcomes & Findings for Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty (NCT NCT01390038)
NCT ID: NCT01390038
Last Updated: 2023-04-25
Results Overview
A subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
157 participants
Primary outcome timeframe
24 months
Results posted on
2023-04-25
Participant Flow
Participant milestones
| Measure |
Simpliciti™ Shoulder System
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Overall Study
STARTED
|
157
|
|
Overall Study
COMPLETED
|
149
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Simpliciti™ Shoulder System
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Simpliciti System Removal
|
2
|
Baseline Characteristics
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
Baseline characteristics by cohort
| Measure |
Simpliciti™ Shoulder System
n=157 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 8.6 • n=39 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 24 monthsA subject is a Patient Success at 24-months if: 1. There is NO continuous radiolucent line around the prosthesis; and 2. The adjusted Constant Score is \> 85 (successful outcome); and 3. They did not have revision surgery; and 4. They did not have a system-related serious adverse event.
Outcome measures
| Measure |
Simpliciti™ Shoulder System
n=149 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Device Success Rate
|
134 participants
|
SECONDARY outcome
Timeframe: 24 monthsSimple Shoulder Test 1 (worse) - 12 (best)
Outcome measures
| Measure |
Simpliciti™ Shoulder System
n=148 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Quality of Life
|
10.8 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 24 months* Elevation in the scapula plane * Internal rotation with arm at the side * External rotation with arm at the side
Outcome measures
| Measure |
Simpliciti™ Shoulder System
n=149 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Range of Motion
Elevation in the Scapular Plan
|
146.6 Degrees
Standard Deviation 23.7
|
|
Range of Motion
Internal Rotation
|
73.9 Degrees
Standard Deviation 1635
|
|
Range of Motion
External Rotation
|
56.4 Degrees
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 24 monthsStrength of a Specific shoulder motion as measured in pounds of force on a dynamometer machine supplied by Tornier
Outcome measures
| Measure |
Simpliciti™ Shoulder System
n=143 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Strength
|
15.7 Pounds
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 24 monthsDevices will be assessed to determine percentage of participants that demonstrated the following after total shoulder arthroplasty: * Migration * Osteolysis * Subsidence
Outcome measures
| Measure |
Simpliciti™ Shoulder System
n=149 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Device Parameters
Migration
|
0 Percentage of participants
|
|
Device Parameters
Osteolysis
|
0 Percentage of participants
|
|
Device Parameters
Subsidence
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 Months0 (worst) - 100 (best)
Outcome measures
| Measure |
Simpliciti™ Shoulder System
n=149 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
American Shoulder and Elbow Surgeon Score
|
91.9 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 24 Months0 (best) - 10 (worst)
Outcome measures
| Measure |
Simpliciti™ Shoulder System
n=149 Participants
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Pain: Visual Analog Scale
|
0.5 units on a scale
Standard Deviation 1.2
|
Adverse Events
Simpliciti™ Shoulder System
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simpliciti™ Shoulder System
n=157 participants at risk
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Aseptic Glenoid Loosening
|
0.64%
1/157 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis, treated shoulder
|
0.64%
1/157 • Number of events 1
|
|
Infections and infestations
Infection
|
0.64%
1/157 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.64%
1/157 • Number of events 1
|
Other adverse events
| Measure |
Simpliciti™ Shoulder System
n=157 participants at risk
The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.
Simpliciti™ Shoulder System: Total shoulder arthroplasty system
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
24.8%
39/157 • Number of events 46
|
|
Musculoskeletal and connective tissue disorders
Pain
|
7.6%
12/157 • Number of events 13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs are restricted from publishing study results until either 18 months after the study is completed or the primary manuscript has been accepted, whichever comes first.
- Publication restrictions are in place
Restriction type: OTHER