Trial Outcomes & Findings for Sidus Stem-Free Shoulder IDE Study (NCT NCT01878253)

NCT ID: NCT01878253

Last Updated: 2019-07-15

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 95 participants
• Primary outcome timeframe: Two years
• Results posted on: 2019-07-15

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	95
Overall Study Pre-Operative	95
Overall Study 6 Weeks	95
Overall Study 6 Months	90
Overall Study 1 Year	88
Overall Study 2 Year	86
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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
Overall Study Death	1
Overall Study SIdus System Removal	3
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	2
Overall Study Completed Study w/o Follow-up Data	2

Baseline Characteristics

Sidus Stem-Free Shoulder IDE Study

Baseline characteristics by cohort

Measure	Sidus Stem-Free Shoulder System n=95 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	66 Participants n=5 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants
Age, Continuous	61 Years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	87 participants n=5 Participants
Race/Ethnicity, Customized African American	4 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 participants n=5 Participants
Race/Ethnicity, Customized Patient Unwilling to Answer	2 participants n=5 Participants
BMI	30.8 kg/m^2 STANDARD_DEVIATION 6.9 • n=5 Participants

PRIMARY outcome

Timeframe: Two years

Population: All participants received the implant as treatment. ASES Functional Score Summary and Pain Scores.

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.

Outcome measures

Measure	Sidus Stem-Free Shoulder System n=86 Participants 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. ASES Functional and Pain Summary scores
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
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 outcome

Timeframe: 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.

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

Outcome measures

Measure	Sidus Stem-Free Shoulder System n=85 Participants 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. ASES Functional and Pain Summary scores
Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment Subjects with Evidence of Radiographic Failure	2 Participants
Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment Subjects with Radiographic Success	83 Participants

PRIMARY outcome

Timeframe: 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.

This outcome will measure the frequency of device related serious adverse events.

Outcome measures

Measure	Sidus Stem-Free Shoulder System n=86 Participants 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. ASES Functional and Pain Summary scores
The Number of Device Related Serious Adverse Events.	0 Device Related Serious Adverse Events

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Sidus Stem-Free Shoulder System n=86 Participants 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. ASES Functional and Pain Summary scores
Survivorship Subject devices that survived	83 Participants
Survivorship Subject devices revised	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sidus Stem-Free Shoulder System n=95 Participants 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. ASES Functional and Pain Summary scores
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
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
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
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
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Sidus Stem-Free Shoulder System n=95 Participants 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. ASES Functional and Pain Summary scores
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
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
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
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
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
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
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
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
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
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

Adverse Events

Sidus Stem-Free Shoulder System

Serious events: 0 serious events

Other events: 28 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sidus Stem-Free Shoulder System n=95 participants at risk 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
Skin and subcutaneous tissue disorders Dermatological	1.1% 1/95 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted until the date of study closure or date of revision (if applicable). If a subject experienced more than 1 of a given AE, the subjects are counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
Musculoskeletal and connective tissue disorders Other General Non-Shoulder Complication	5.3% 5/95 • Number of events 11 • Reported Adverse Events (AEs) include events from the date each subject was implanted until the date of study closure or date of revision (if applicable). If a subject experienced more than 1 of a given AE, the subjects are counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
Musculoskeletal and connective tissue disorders Fracture of Proximal Humerus	1.1% 1/95 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted until the date of study closure or date of revision (if applicable). If a subject experienced more than 1 of a given AE, the subjects are counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
Musculoskeletal and connective tissue disorders Glenoid Implant Loosening	3.2% 3/95 • Number of events 3 • Reported Adverse Events (AEs) include events from the date each subject was implanted until the date of study closure or date of revision (if applicable). If a subject experienced more than 1 of a given AE, the subjects are counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.
Musculoskeletal and connective tissue disorders Other Shoulder Related Complication	22.1% 21/95 • Number of events 29 • Reported Adverse Events (AEs) include events from the date each subject was implanted until the date of study closure or date of revision (if applicable). If a subject experienced more than 1 of a given AE, the subjects are counted only once for that AE. If a subject experienced more than one AE in a system organ class (SOC), the subject is counted only once in that SOC.

Additional Information

Clinical Operation Director

Zimmer Biomet Inc

Phone: 574-371-9823

Email: Bill.Bourdeau@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator must provide the Sponsor at least 30 days to review publications for legal and regulatory compliance and will include in publications a statement that the study was supported by the Sponsor. Sponsor confidential information will not be submitted for publication without Sponsor consent. Sponsor may request delay of publication for 60 days to allow for patent application filing.
• Publication restrictions are in place

Restriction type: OTHER