Osteoarthritis, Post Traumatic Arthritis
Conditions
Brief summary
This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.
Detailed description
This study will be multi-centre and non-comparative. Subjects will be recruited and followed up at similar intervals to reflect the standard clinical practice and intended population for wider use of the device. 157 non-randomised subjects will be recruited from approximately 15 sites. A maximum of 30 subjects may be recruited from one site. More than one implanting surgeon may recruit subjects at each site as a designated sub-Investigator. The primary objective of this PMCF study is to confirm device survivorship of the GLOBAL ICON stemless humeral component at 24 months post-operative. The secondary objectives include the evaluation of clinical performance, radiographic performance and safety outcomes at 3, 12, 24, 60 and 120 months post-operatively. Tertiary endpoints in the study will include a mean change from baseline for the Adjusted Constant-Murley Score, the Oxford Shoulder Score, the EQ-5D-5L dimension score and EQ-VAS scores. Radiographic evidence of aseptic loosening and periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral component will be assessed.
Interventions
DEVICEGlobal ICON
The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.
Sponsors
DePuy Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
Severely painful and/or severely disabled Non-Inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post traumatic arthritis Patient is willing and able to complete the required post-operative schedule Patient has provided written Informed Consent to participate
Exclusion criteria
Subjects under the age of 21 or over the age of 80 on the day of consent Subjects who have not reached skeletal maturity, regardless of age Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the GLOBAL ICON stemless humeral components Bone that is too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e osteoporosis or sclerotic bone, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid Fractures of the proximal humerus that could compromise the fixation of the GLOBAL ICON stemless humeral components Subjects who have undergone previous treatment on the study shoulder that may compromise fixation of the GLOBAL ICON stemless humeral components Revision of a failed hemi, total or reverse shoulder arthroplasty Active local or systemic infection Absent, irreparable or nonfunctional rotator cuff or other essential muscles Subject is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids Subjects who, at the point of enrolment, already have a GLOBAL ICON shoulder replacement or are scheduled to receive, a contralateral shoulder replacement device Subjects who are known to be pregnant or breastfeeding Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes Subjects with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders) Known polyethylene and/or metal sensitivity or allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-related Serious Adverse Events | 24 months | Adverse events are any untoward health issues that occur when compared to a participant's normal health baseline. Serious adverse events include health events that have led to death or a serious deterioration in health that resulted in life threatening illness/injury, permanent impairment of a body structure, required hospitalization or required medical intervention to prevent life threatening illness/injury or permanent impairment to a body structure or function. |
| Percentage of Participants With Overall Composite Clinical Success | At 24 months | Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (\>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events. |
| Adjusted Constant-Murley Shoulder Assessment Score | 24 Months | Constant-Murley Score on operative shoulder adjusted for gender and age. Please note that scores are adjusted to reflect gender and age of participants. The Constant-Murley score is divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100) Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant is 0-178.6; the range for the Adjusted Constant-Murley score in a female participant is 0-192.3. Please note the calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants. |
| Continuous Radiolucent Line | 24 months | X-rays are reviewed by an independent radiographic reviewer to determine if a 1 mm wide or greater, continuous radiolucent line around the entire bony border of the GLOBAL ICON Stemless Shoulder implant exists. Such a line may indicate the implant is loosening. |
| Kaplan Meier Survivorship | 24 months | Kaplan Meier Survival Estimate is based upon the number of GLOBAL ICON implants remaining in the study and the number of GLOBAL ICON implants that have been revised (surgically removed from participants). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | At Baseline (Day 0), 3, 12, 24, and 60 months | Constant-Murley Score was adjusted to reflect gender and age of participants. The Constant-Murley score was divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100). Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant was 0-178.6; the range for the Adjusted Constant-Murley score in a female participant was 0-192.3. The calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants. |
| Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | At Baseline (Day 0), 3, 12, 24, and 60 months | The Oxford Shoulder Score (OSS) was a patient-based questionnaire used to assess shoulder pain after surgery. It consisted of 12 questionnaire items with 5 ordinal response options for each question. Each response was scored from 0 to 4 points (4 = best/least problems and 0=worst/unbearable pain). All item scores across 12 questions were summed to produce a scale of 0-48 (where a higher score reflected best/least problems). |
| Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | At Baseline (Day 0), 3, 12, 24, and 60 months | Mean EQ-5D-5L scores by dimensions at baseline, 3, 12, 24, and 60 months were reported. EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5-item index score was transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher score indicated good health. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement. |
| Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | At Baseline (Day 0), 3, 12, 24, and 60 months | EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement. |
| Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months | Number of participants with radiographic evidence of aseptic loosening of the global icon stemless humeral component immediate post-operative and 3, 12, 24 and 60 months post-operative were reported. Aseptic Loosening was evaluated using all available imaging. Progressing radiolucencies and/or stress shielding indicated aseptic loosening. |
Countries
Canada, Germany, Netherlands, United Kingdom
Participant flow
Recruitment details
Patients were selected for recruitment into the study from the general diagnosis population defined as total shoulder arthroplasty (TSA). The investigation was conducted at 12 centers.
Participants by arm
| Arm | Count |
|---|---|
| GLOBAL ICON Stemless Shoulder System Study participants who received a GLOBAL ICON Stemless shoulder system | 156 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 3 |
| Overall Study | Investigator's Decision | 137 |
| Overall Study | Other | 2 |
| Overall Study | Started but not treated with GLOBAL ICON | 15 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | GLOBAL ICON Stemless Shoulder System | — |
|---|---|---|
| Age, Continuous Study participant age (mean) | 66.0 Years STANDARD_DEVIATION 9.04 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Gender of study participants Female | 80 Participants | — |
| Sex: Female, Male Gender of study participants Male | 76 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 171 |
| other Total, other adverse events | 100 / 156 |
| serious Total, serious adverse events | 75 / 156 |
Outcome results
Primary
Adjusted Constant-Murley Shoulder Assessment Score
Constant-Murley Score on operative shoulder adjusted for gender and age. Please note that scores are adjusted to reflect gender and age of participants. The Constant-Murley score is divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100) Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant is 0-178.6; the range for the Adjusted Constant-Murley score in a female participant is 0-192.3. Please note the calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants.
Time frame: 24 Months
Population: Study participants who received a GLOBAL ICON Shoulder system.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Adjusted Constant-Murley Shoulder Assessment Score | 103.7 Units on a scale | Standard Deviation 21.8 |
Primary
Continuous Radiolucent Line
X-rays are reviewed by an independent radiographic reviewer to determine if a 1 mm wide or greater, continuous radiolucent line around the entire bony border of the GLOBAL ICON Stemless Shoulder implant exists. Such a line may indicate the implant is loosening.
Time frame: 24 months
Population: All participants who received a GLOBAL ICON Stemless Shoulder were evaluated radiographically at 24 months for the presence of a continuous radiolucent line around the implant that was greater than 1mm wide.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Continuous Radiolucent Line | 0 Participants |
Primary
Device-related Serious Adverse Events
Adverse events are any untoward health issues that occur when compared to a participant's normal health baseline. Serious adverse events include health events that have led to death or a serious deterioration in health that resulted in life threatening illness/injury, permanent impairment of a body structure, required hospitalization or required medical intervention to prevent life threatening illness/injury or permanent impairment to a body structure or function.
Time frame: 24 months
Population: Study participants who received a GLOBAL ICON shoulder system
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Device-related Serious Adverse Events | 1 Participants |
Primary
Kaplan Meier Survivorship
Kaplan Meier Survival Estimate is based upon the number of GLOBAL ICON implants remaining in the study and the number of GLOBAL ICON implants that have been revised (surgically removed from participants).
Time frame: 24 months
Population: Study participants who received a GLOBAL ICON Shoulder System.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Kaplan Meier Survivorship | 98.7 Percentage of implants |
Primary
Percentage of Participants With Overall Composite Clinical Success
Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (\>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events.
Time frame: At 24 months
Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Percentage of Participants With Overall Composite Clinical Success | 82.86 Percentage of participants |
Secondary
Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative
Constant-Murley Score was adjusted to reflect gender and age of participants. The Constant-Murley score was divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100). Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant was 0-178.6; the range for the Adjusted Constant-Murley score in a female participant was 0-192.3. The calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants.
Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months
Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | Baseline | 42.2 Unit on a scale | Standard Deviation 22.5 |
| GLOBAL ICON Stemless Shoulder System | Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 3 Months | 70.0 Unit on a scale | Standard Deviation 23.1 |
| GLOBAL ICON Stemless Shoulder System | Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 12 Months | 95.5 Unit on a scale | Standard Deviation 22.8 |
| GLOBAL ICON Stemless Shoulder System | Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 24 Months | 103.7 Unit on a scale | Standard Deviation 21.7 |
| GLOBAL ICON Stemless Shoulder System | Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 60 Months | 106.2 Unit on a scale | Standard Deviation 21.7 |
Secondary
Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative
Mean EQ-5D-5L scores by dimensions at baseline, 3, 12, 24, and 60 months were reported. EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5-item index score was transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher score indicated good health. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.
Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months
Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Mobility: Baseline | 1.8 Unit on a Scale | Standard Deviation 1.04 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Mobility: 3 Months | 1.5 Unit on a Scale | Standard Deviation 0.9 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Mobility: 12 Months | 1.6 Unit on a Scale | Standard Deviation 0.93 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Mobility: 24 Months | 1.7 Unit on a Scale | Standard Deviation 0.99 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Mobility: 60 Months | 1.7 Unit on a Scale | Standard Deviation 0.97 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Self-Care: Baseline | 2.4 Unit on a Scale | Standard Deviation 1.02 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Self-Care: 3 Months | 1.6 Unit on a Scale | Standard Deviation 0.87 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Self-Care: 12 Months | 1.3 Unit on a Scale | Standard Deviation 0.61 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Self-Care: 24 Months | 1.3 Unit on a Scale | Standard Deviation 0.61 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Self-Care: 60 Months | 1.3 Unit on a Scale | Standard Deviation 0.67 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Usual Activities: Baseline | 3.0 Unit on a Scale | Standard Deviation 1 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Usual Activities: 3 Months | 2.0 Unit on a Scale | Standard Deviation 0.97 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Usual Activities: 12 Months | 1.6 Unit on a Scale | Standard Deviation 0.85 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Usual Activities: 24 Months | 1.5 Unit on a Scale | Standard Deviation 0.87 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Usual Activities: 60 Months | 1.6 Unit on a Scale | Standard Deviation 0.83 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Pain/Discomfort: Baseline | 3.5 Unit on a Scale | Standard Deviation 0.82 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Pain/Discomfort: 3 Months | 2.2 Unit on a Scale | Standard Deviation 0.8 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Pain/Discomfort: 12 Months | 2.0 Unit on a Scale | Standard Deviation 0.94 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Pain/Discomfort: 24 Months | 1.9 Unit on a Scale | Standard Deviation 0.97 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Pain/Discomfort: 60 Months | 2.1 Unit on a Scale | Standard Deviation 1.01 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Anxiety/Depression: Baseline | 1.7 Unit on a Scale | Standard Deviation 0.98 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Anxiety/Depression: 3 Months | 1.4 Unit on a Scale | Standard Deviation 0.76 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Anxiety/Depression: 12 Months | 1.4 Unit on a Scale | Standard Deviation 0.75 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Anxiety/Depression: 24 Months | 1.4 Unit on a Scale | Standard Deviation 0.78 |
| GLOBAL ICON Stemless Shoulder System | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Anxiety/Depression: 60 Months | 1.3 Unit on a Scale | Standard Deviation 0.66 |
Secondary
Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative
The Oxford Shoulder Score (OSS) was a patient-based questionnaire used to assess shoulder pain after surgery. It consisted of 12 questionnaire items with 5 ordinal response options for each question. Each response was scored from 0 to 4 points (4 = best/least problems and 0=worst/unbearable pain). All item scores across 12 questions were summed to produce a scale of 0-48 (where a higher score reflected best/least problems).
Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months
Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number of participants analyzed) signifies number participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | Baseline | 20.6 Unit on a Scale | Standard Deviation 8.2 |
| GLOBAL ICON Stemless Shoulder System | Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 3 Months | 35.1 Unit on a Scale | Standard Deviation 9.8 |
| GLOBAL ICON Stemless Shoulder System | Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 12 Months | 41.9 Unit on a Scale | Standard Deviation 7.7 |
| GLOBAL ICON Stemless Shoulder System | Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 24 Months | 43.1 Unit on a Scale | Standard Deviation 7.4 |
| GLOBAL ICON Stemless Shoulder System | Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 60 Months | 43.5 Unit on a Scale | Standard Deviation 7.6 |
Secondary
Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative
EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement.
Time frame: At Baseline (Day 0), 3, 12, 24, and 60 months
Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | Baseline | 64.7 Unit on a scale | Standard Deviation 21.9 |
| GLOBAL ICON Stemless Shoulder System | Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 3 Months | 75.6 Unit on a scale | Standard Deviation 15.8 |
| GLOBAL ICON Stemless Shoulder System | Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 12 Months | 78.1 Unit on a scale | Standard Deviation 17.6 |
| GLOBAL ICON Stemless Shoulder System | Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 24 Months | 79.3 Unit on a scale | Standard Deviation 16.3 |
| GLOBAL ICON Stemless Shoulder System | Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | 60 Months | 78.0 Unit on a scale | Standard Deviation 17.6 |
Secondary
Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative
Number of participants with radiographic evidence of aseptic loosening of the global icon stemless humeral component immediate post-operative and 3, 12, 24 and 60 months post-operative were reported. Aseptic Loosening was evaluated using all available imaging. Progressing radiolucencies and/or stress shielding indicated aseptic loosening.
Time frame: Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months
Population: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GLOBAL ICON Stemless Shoulder System | Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | Immediate Post Operative | 0 Participants |
| GLOBAL ICON Stemless Shoulder System | Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | 3 Months | 0 Participants |
| GLOBAL ICON Stemless Shoulder System | Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | 12 Months | 0 Participants |
| GLOBAL ICON Stemless Shoulder System | Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | 24 Months | 0 Participants |
| GLOBAL ICON Stemless Shoulder System | Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | 60 Months | 0 Participants |