Trial Outcomes & Findings for Anatomical Shoulder™ Inverse/Reverse Study (NCT NCT02466321)
NCT ID: NCT02466321
Last Updated: 2025-06-12
Results Overview
Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
10 years
Results posted on
2025-06-12
Participant Flow
Unit of analysis: Implants
Participant milestones
| Measure |
Anatomical Shoulder Inverse/Reverse Prosthesis
Subjects implanted with the Anatomical Shoulder Inverse/reverse prosthesis
|
|---|---|
|
Overall Study
STARTED
|
154 154
|
|
Overall Study
Received Study Device
|
153 153
|
|
Overall Study
COMPLETED
|
61 61
|
|
Overall Study
NOT COMPLETED
|
93 93
|
Reasons for withdrawal
| Measure |
Anatomical Shoulder Inverse/Reverse Prosthesis
Subjects implanted with the Anatomical Shoulder Inverse/reverse prosthesis
|
|---|---|
|
Overall Study
Death
|
26
|
|
Overall Study
Revision
|
6
|
|
Overall Study
Lost to Follow-up
|
60
|
|
Overall Study
Did not receive study device
|
1
|
Baseline Characteristics
153 is the number for the analysis
Baseline characteristics by cohort
| Measure |
Inverse / Reverse Shoulder
n=153 implants
Patient treated with a inverse / reverse shoulder device.
Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System
|
|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 6.1 • n=153 Participants • 153 is the number for the analysis
|
|
Sex: Female, Male
Female
|
97 Participants
n=153 Participants • 155 participants were enrolled, 153 serve as basis for the analysis
|
|
Sex: Female, Male
Male
|
56 Participants
n=153 Participants • 155 participants were enrolled, 153 serve as basis for the analysis
|
|
Region of Enrollment
Belgium
|
19 participants
n=153 Participants • 155 participants were enrolled, only 153 cases were operated with the study device and serve for the final results.
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=153 Participants • 155 participants were enrolled, only 153 cases were operated with the study device and serve for the final results.
|
|
Region of Enrollment
Switzerland
|
50 participants
n=153 Participants • 155 participants were enrolled, only 153 cases were operated with the study device and serve for the final results.
|
|
Region of Enrollment
Germany
|
71 participants
n=153 Participants • 155 participants were enrolled, only 153 cases were operated with the study device and serve for the final results.
|
|
BMI
|
27.2 kg/m2
STANDARD_DEVIATION 4.5 • n=153 Participants • 155 participants were enrolled but the analysis of results are based on 153 participants implanted with the study device
|
|
Height
|
165.0 cm
STANDARD_DEVIATION 8.4 • n=153 Participants • 153 is the number of participants receiving the study device , this number serves the final analysis
|
|
Weight
|
74.1 kg
STANDARD_DEVIATION 14.3 • n=153 Participants • 153 participants received the study device and serve as the final analysis
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: For 42 participants constant \& Murley score were available from baseline to 10 years follow-up.
Constant \& Murley Score. This evaluates clinical parameters such as range of motion, power, level of pain and functional ability. The score ranges from 0 - 100 with a higher score representing a better outcome.
Outcome measures
| Measure |
Inverse / Reverse Shoulder
n=42 Implants
Patient treated with a inverse / reverse shoulder device.
Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System
|
|---|---|
|
Functional Performance
|
57.9 score on a scale
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: 10 yearsThe Kaplan-Meier estimator is a non-parametric statistic used to estimate the survival function from lifetime data. It is used to measure the fraction of patients living (in this case without a revision surgery) for a certain amount of time after treatment. A higher score is a better outcome.
Outcome measures
| Measure |
Inverse / Reverse Shoulder
n=153 Implants
Patient treated with a inverse / reverse shoulder device.
Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System
|
|---|---|
|
Survival (Kaplan-Meier)
|
147 Implants
|
Adverse Events
Inverse / Reverse Shoulder
Serious events: 58 serious events
Other events: 0 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Inverse / Reverse Shoulder
n=153 participants at risk
Patient treated with a inverse / reverse shoulder device.
Inverse/Reverse Shoulder Arthroplasty: Implantation of the Anatomical Shoulder Inverse/Reverse System
|
|---|---|
|
General disorders
Death due to unrelated reasons
|
17.0%
26/153 • Number of events 26 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Blood and lymphatic system disorders
Anemia
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
1.3%
2/153 • Number of events 2 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
1.3%
2/153 • Number of events 2 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Musculoskeletal and connective tissue disorders
Fracture of femoral neck
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Musculoskeletal and connective tissue disorders
Fracture of proximal humerus
|
3.3%
5/153 • Number of events 5 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Musculoskeletal and connective tissue disorders
Glenoid implant failure
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Musculoskeletal and connective tissue disorders
Glenoid implant loosening
|
2.0%
3/153 • Number of events 3 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Blood and lymphatic system disorders
hematoma
|
1.3%
2/153 • Number of events 2 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Blood and lymphatic system disorders
hemorrhage
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Musculoskeletal and connective tissue disorders
humeral implant loosening
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Nervous system disorders
Nerve deficit
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Nervous system disorders
nerve injury
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
General disorders
Other general complication (not shoulder)
|
10.5%
16/153 • Number of events 16 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Musculoskeletal and connective tissue disorders
Other shoulder related complication
|
2.6%
4/153 • Number of events 4 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory infection
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
|
Surgical and medical procedures
Wound dehiscence
|
0.65%
1/153 • Number of events 1 • AEs were collected from the time of surgery until study completion (up to 10 years)
Seriousness of the Adverse Events were not assessed. Therefore, all Adverse Events are listed in the Serious Adverse Events table.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60