Trial Outcomes & Findings for Impact of Humeral Component Version on Outcomes Following RTSA (NCT NCT03111147)
NCT ID: NCT03111147
Last Updated: 2024-03-05
Results Overview
External range of motion measurements of the shoulder in degrees
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
2 years
Results posted on
2024-03-05
Participant Flow
Of 95 patients recruited, 85 met inclusion criteria and were randomized to treatment groups.
Participant milestones
| Measure |
0 Degrees Humeral Component Version
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version
|
30 Degrees Humeral Component Retroversion
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
0 Degrees Humeral Component Version
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version
|
30 Degrees Humeral Component Retroversion
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Death
|
1
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
0 Degrees Humeral Component Version
n=42 Participants
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version
|
30 Degrees Humeral Component Retroversion
n=43 Participants
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.20 years
STANDARD_DEVIATION 8.21 • n=42 Participants
|
69.19 years
STANDARD_DEVIATION 7.45 • n=43 Participants
|
69.19 years
STANDARD_DEVIATION 7.78 • n=85 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=42 Participants
|
31 Participants
n=43 Participants
|
54 Participants
n=85 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=42 Participants
|
12 Participants
n=43 Participants
|
31 Participants
n=85 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
42 Participants
n=42 Participants
|
43 Participants
n=43 Participants
|
85 Participants
n=85 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 9 participants in the 0 degrees humeral component version and 10 patients in the 30 degrees humeral component retroversion did not complete study activities and no data was collected.
External range of motion measurements of the shoulder in degrees
Outcome measures
| Measure |
0 Degrees Humeral Component Version
n=33 Participants
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version
|
30 Degrees Humeral Component Retroversion
n=33 Participants
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion
|
|---|---|---|
|
Postoperative External Range of Motion (ROM)
|
35 degrees
Standard Error 3.4
|
39 degrees
Standard Error 2.1
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 9 participants in the 0 degrees humeral component version and 10 patients in the 30 degrees humeral component retroversion did not complete study activities and no data was collected.
Internal range of motion measurements of the shoulder in degrees
Outcome measures
| Measure |
0 Degrees Humeral Component Version
n=33 Participants
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version
|
30 Degrees Humeral Component Retroversion
n=33 Participants
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion
|
|---|---|---|
|
Postoperative Internal Range of Motion (ROM)
|
35.5 degrees
Standard Error 3.2
|
33.5 degrees
Standard Error 2.5
|
Adverse Events
0 Degrees Humeral Component Version
Serious events: 1 serious events
Other events: 11 other events
Deaths: 1 deaths
30 Degrees Humeral Component Retroversion
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
0 Degrees Humeral Component Version
n=42 participants at risk
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version
|
30 Degrees Humeral Component Retroversion
n=43 participants at risk
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion
|
|---|---|---|
|
Surgical and medical procedures
Revision Reverse Total Shoulder Arthroplasty
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
4.7%
2/43 • Number of events 2 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Infections and infestations
COVID Infection resulting in Death
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
Other adverse events
| Measure |
0 Degrees Humeral Component Version
n=42 participants at risk
Reverse Total Shoulder Arthroplasty with humeral component positioned in 0 degrees of version
0 degrees humeral component version: RTSA with humeral component positioned in 0 degrees of version
|
30 Degrees Humeral Component Retroversion
n=43 participants at risk
Reverse Total Shoulder Arthroplasty with humeral component positioned in 30 degrees of retroversion
30 degrees humeral component retroversion: RTSA with humeral component positioned in 30 degrees of retroversion
|
|---|---|---|
|
Injury, poisoning and procedural complications
Heteroptopic ossification on inferior glenoid
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
7.0%
3/43 • Number of events 3 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Pain
|
16.7%
7/42 • Number of events 7 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
16.3%
7/43 • Number of events 7 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Impingement
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
7.0%
3/43 • Number of events 3 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Crepitus
|
4.8%
2/42 • Number of events 2 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Inferior Scapular Notching
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Interval Bony Healing
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Chronic changes to the distal acronium
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Injury, poisoning and procedural complications
New onset shoulder weakness
|
4.8%
2/42 • Number of events 2 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
4.7%
2/43 • Number of events 2 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Scapular spine tenderness
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Tendinitis (Deltoid)
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Fracture (Scapular body)
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Numbness
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Injury, poisoning and procedural complications
Brachioplexopathy
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Injury, poisoning and procedural complications
Limited Range of Motion
|
4.8%
2/42 • Number of events 2 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Muscle Spams
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
shoulder injury
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
humeral head subluxed inferiorly
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Injury, poisoning and procedural complications
elevated C-reactive protein
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
shoulder aspiration
|
2.4%
1/42 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
0.00%
0/43 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Lateral deltoid insertion pain
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Shoulder strain
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
Lucency around stem of humeral component
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
ecchymosis of proximal arm
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
new onset instability
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
positive sulcus sign
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
|
Musculoskeletal and connective tissue disorders
cortisone injection
|
0.00%
0/42 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
2.3%
1/43 • Number of events 1 • 2 years
Only shoulder related adverse events were assessed and collected per protocol
|
Additional Information
Pamela Sloan, Clinical Research Manager
William Beaumont Hospitals
Phone: 248-551-6059
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place