Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis
Conditions
Keywords
Total Shoulder Arthoplasty
Brief summary
The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.
Detailed description
The primary objectives of this study are to evaluate the safety and efficacy (defined as follows) of the Sidus Stem-Free Shoulder System in unilateral primary total shoulder arthroplasty. Safety: Will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects (UADEs) in investigational subjects as well as analyzing survivorship using revision or intended revision as an endpoint. Efficacy: Will be determined by comparing the overall pain and functional performance, survivorship and radiographic success of investigational subjects with those subjects who received the control devices.
Interventions
DEVICESidus Stem-Free Total Shoulder Arthroplasty System
Sponsors
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be 22 years of age or older. * Patient is skeletally mature. * Patient must have signed the IRB/EC approved informed consent. * Patient is a candidate for a total shoulder arthroplasty (replacement of humeral head and glenoid). * Patient has a diagnosis of primary osteoarthritis of the shoulder of grade III or higher. * Patient has experienced symptoms of shoulder pain and/or loss of function for at least 6 months and has a maximum ASES score of 40. * Patient has no findings to indicate an etiology of acute trauma, infection, avascular necrosis or inflammatory arthropathy of the operative shoulder. * Patient has undergone no previous reconstructive shoulder surgery. Acceptable previous shoulder surgeries include arthroscopy, soft tissue repair, or pinning/screw fixation due to a historic fracture. * Patient is willing and able to comply with the required post-operative therapy as defined in the protocol. * Patient is willing and able to comply with the required follow-up schedule as defined in the protocol.
Exclusion criteria
* Patient is a prisoner. * Patient is a known current alcohol or drug abuser. * Patient has a psychiatric illness or cognitive deficit that precluded informed consent. * Patient has a chronic renal impairment or failure. * Patient sensitivity to implant materials. * Patient has a vascular insufficiency due to large or small vessel disease which could inhibit postoperative healing. * Patient is currently receiving or has received within the last 3 months chronic systemic or inhaled steroids. This exclusion does not apply to those patients with occasional inhaler use due to seasonal allergies. * Local rash or skin infection around the intended operative site. * Patients with ongoing Worker's Compensation or third party liability claims related to the operative shoulder. * Pre-existing contra-lateral shoulder replacement less than 6 months ago. * Patient who will require a contra-lateral shoulder replacement less than 6 months from the current planned shoulder replacement. * Patient has evidence of major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, or previous shoulder surgery (other than arthroscopy, soft tissue repair, or pinning/screw fixation due to historic fracture). * Patient has significant muscle paralysis. * Patient has Charcot arthropathy. * Patient has metaphyseal bony defects at the bone/implant interface which could inhibit prosthesis fixation. * Patient has a preoperative computed tomography scans or other radiographic images of the shoulder that showed insufficient glenoid or humeral bone stock to allow for implantation of the prosthesis. * Insufficient bone stock exists in the presence of metabolic bone disease (i.e. osteoporosis or severe osteopenia), cancer and radiation. * Patient with severe glenoid deficiency. * Prior fracture of the operative shoulder with the presence of malunion or non-union. * Prior tuberosity fracture with the presence of malunion or non-union. * Patient has an active joint or systemic infection. * Patient has a life expectancy of less than two years. * Patient with unacceptably high operative risk. * Patient unwilling to sign protocol required informed consent. * Patient is unwilling to complete the protocol required radiographic imaging. * Patient is unwilling to complete the protocol required follow-up of two years. * Patient is known to be pregnant. * Intraoperative findings which indicate insufficient bone stock or local deformities which could inhibit prosthesis fixation. Final assessment of bone quality will be completed intraoperatively upon resection of the humeral head and prior to insertion of the anchor as described in the surgical technique. If there is any doubt regarding bone quality affecting the stable fixation of the anchor, the surgeon must use a stemmed prosthesis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Device Related Serious Adverse Events. | Two years | This outcome will measure the frequency of device related serious adverse events. |
| Survivorship | Up to Two years | The Kaplan-Meier method was used for this study. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 2 years post-operative (whichever came first). |
| Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | Two years | Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best. |
| Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment | Two years | absence of radiographic evidence of pending failure of the humeral components, assessed at 2 years which may include the following: * implant fracture * progressive implant migration or subsidence ≥ 5 mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | 6 weeks, 6 months, and 1 year | Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best. |
| SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | Pre-Op, 6 weeks, 6 months, 1 year and 2 years | SF-12 Mental Health and Physical Composite Scores. SF-12 is a validated health survey that uses 12 questions to measure functional health and well being from the patient's point of view. The SF-12 is calculated on a scale of 0 to 100, where a 0 is the worst level of health and 100 is the best level of health. The scores are then normalized with a mean score of 50 and a standard deviation of 10, so that scores greater than 50 represent a health level better than average, and scores less than 50 represent a level lower than average. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sidus Stem-Free Shoulder System This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.
Sidus Stem-Free Total Shoulder Arthroplasty System | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Completed Study w/o Follow-up Data | 2 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | SIdus System Removal | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Sidus Stem-Free Shoulder System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 29 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants |
| Age, Continuous | 61 Years STANDARD_DEVIATION 9.3 |
| BMI | 30.8 kg/m^2 STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized African American | 4 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 participants |
| Race/Ethnicity, Customized Patient Unwilling to Answer | 2 participants |
| Race/Ethnicity, Customized White Non-Hispanic | 87 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 95 |
| other Total, other adverse events | 28 / 95 |
| serious Total, serious adverse events | 0 / 95 |
Outcome results
Primary
Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment
absence of radiographic evidence of pending failure of the humeral components, assessed at 2 years which may include the following: * implant fracture * progressive implant migration or subsidence ≥ 5 mm
Time frame: Two years
Population: Participants who had received the implant. 85 subjects had radiographic images available at the 2 year time point.. Radiographies were assessed at 2 years for implant fracture, failure of humeral components and progressive implant migration or subsidence greater or equal to 5 mm.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sidus Stem-Free Shoulder System | Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment | Subjects with Evidence of Radiographic Failure | 2 Participants |
| Sidus Stem-Free Shoulder System | Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment | Subjects with Radiographic Success | 83 Participants |
Primary
Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Time frame: Two years
Population: All participants received the implant as treatment. ASES Functional Score Summary and Pain Scores.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sidus Stem-Free Shoulder System | Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Functional Score | 89.4 score on a scale | Standard Deviation 13.3 |
| Sidus Stem-Free Shoulder System | Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Pain Score | 0.7 score on a scale | Standard Deviation 1.5 |
Primary
Survivorship
The Kaplan-Meier method was used for this study. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 2 years post-operative (whichever came first).
Time frame: Up to Two years
Population: At the two year study endpoint there were 86 subjects that had data available at the two year time point.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sidus Stem-Free Shoulder System | Survivorship | Subject devices that survived | 83 Participants |
| Sidus Stem-Free Shoulder System | Survivorship | Subject devices revised | 3 Participants |
Primary
The Number of Device Related Serious Adverse Events.
This outcome will measure the frequency of device related serious adverse events.
Time frame: Two years
Population: This outcome will measure the frequency of device related serious adverse events. At the two year endpoint of the study there were a total of 86 participants with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sidus Stem-Free Shoulder System | The Number of Device Related Serious Adverse Events. | 0 Device Related Serious Adverse Events |
Secondary
ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Pain and function as measured by the American Society of Shoulder and Elbow Surgeons questionnaire. ASES consists of 3 subcomponent scores including pain, instability and activities of daily living. The pain score can be 0 to 10 with 0 being no pain and 10 being the worst pain imaginable. The instability score can be 0 to 10 with 0 being no instability and 10 being the worst instability imaginable. The activities of daily living consists of 10 questions with ordinal responses of 0, 1, 2, and 3. 3 involves no limitation and 0 is unable to do. The 3 subcomponents combine to make the overall ASES score which can range from 0 to 100 with 0 being the worst possible score and 100 being the best.
Time frame: 6 weeks, 6 months, and 1 year
Population: ASES Functional Score Summary and Pain Scores. 95 Participants had ASES data at 6 weeks, 90 at 6 months and 88 at 1 year. At 6 weeks 1 subject was missing data required to calculate the ASES functional score, had pain score data present.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sidus Stem-Free Shoulder System | ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Functional Score 6 Weeks | 59.8 score on a scale | Standard Deviation 18.2 |
| Sidus Stem-Free Shoulder System | ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Functional Score 6 Months | 80.3 score on a scale | Standard Deviation 20.1 |
| Sidus Stem-Free Shoulder System | ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Functional Score 1 Year | 88.1 score on a scale | Standard Deviation 14.5 |
| Sidus Stem-Free Shoulder System | ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Pain Score 6 weeks | 2 score on a scale | Standard Deviation 2.4 |
| Sidus Stem-Free Shoulder System | ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Pain Score 6 months | 1.3 score on a scale | Standard Deviation 2.2 |
| Sidus Stem-Free Shoulder System | ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire | ASES Pain Score 1 year | 0.7 score on a scale | Standard Deviation 1.5 |
Secondary
SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire.
SF-12 Mental Health and Physical Composite Scores. SF-12 is a validated health survey that uses 12 questions to measure functional health and well being from the patient's point of view. The SF-12 is calculated on a scale of 0 to 100, where a 0 is the worst level of health and 100 is the best level of health. The scores are then normalized with a mean score of 50 and a standard deviation of 10, so that scores greater than 50 represent a health level better than average, and scores less than 50 represent a level lower than average.
Time frame: Pre-Op, 6 weeks, 6 months, 1 year and 2 years
Population: SF-12 Mental Health and Physical Composite Scores. 95 subjects had data Pre-operatively, 94 at 6 weeks, 90 at 6 months, 88 at 1 year and 86 at 2 years. One subject at the 6 weeks interval had completed the physical portion of the SF-12 but did not complete all requirements to calculate the SF-12 Mental Score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Mental Health Scores Pre-Op | 50 score on a scale | Standard Deviation 13.5 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Mental Health Scores 6 Weeks | 55.1 score on a scale | Standard Deviation 10.5 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Mental Health Scores 6 Months | 55.5 score on a scale | Standard Deviation 8.4 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Mental Health Scores 1 Year | 54.3 score on a scale | Standard Deviation 9.1 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Mental Health Scores 2 Year | 54.3 score on a scale | Standard Deviation 8.3 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Physical Composite Scores Pre-Op | 32.7 score on a scale | Standard Deviation 6.9 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Physical Composite Scores 6 weeks | 36.5 score on a scale | Standard Deviation 8.3 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Physical Composite Scores 6 months | 44.2 score on a scale | Standard Deviation 10.6 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Physical Composite Scores 1 year | 46.2 score on a scale | Standard Deviation 10.3 |
| Sidus Stem-Free Shoulder System | SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire. | SF-12 Physical Composite Scores 2 year | 47.6 score on a scale | Standard Deviation 8.7 |