Sidus Stem-Free Shoulder IDE Study

• Sponsor: Zimmer Biomet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01878253
• Collaborator: (none)
• Enrollment: 95
• Locations: 11
• Arm: 1
• Duration (Months): 66
• Patients Per Site: 8.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis; Posttraumatic Arthrosis; Rheumatoid Arthritis	Device: Sidus Stem-Free Total Shoulder Arthroplasty System	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.	Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

3. The Number of Device Related Serious Adverse Events. [Two years]

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

4. 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).

Secondary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Redwood City	California	United States	94063
2	University of California San Francisco - Orthopaedics Institute	San Francisco	California	United States	94158
3	St. Joseph's Hospital of Atlanta	Atlanta	Georgia	United States	30342
4	Norton Orthopaedic & Sports Medicine	Louisville	Kentucky	United States	40241
5	MedStar Health	Baltimore	Maryland	United States	21218
6	Washington University	Saint Louis	Missouri	United States	63110
7	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033
8	Rothman Institute	Philadelphia	Pennsylvania	United States	19107
9	University of Calgary Sports Medicine Clinic	Calgary	Alberta	Canada	T2N 1N4
10	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
11	St. Joseph's Health Care London - Hand and Upper Limb Centre	London	Ontario	Canada	N6A 4L6

Sponsors and Collaborators

• Zimmer Biomet

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jul 30, 2013

More Information

Publications

None provided.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT01878253
• Other Study ID Numbers: CIU2012-12E; G130026
• First Posted: Jun 14, 2013
• Last Update Posted: Jul 15, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Zimmer Biomet: Total Shoulder Arthoplasty
• Additional relevant MeSH terms: Osteoarthritis

Study Results

Participant Flow

Arm/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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
Period Title: Overall Study
STARTED	95
Pre-Operative	95
6 Weeks	95
6 Months	90
1 Year	88
2 Year	86
COMPLETED	86
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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 Participants	95
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	66 69.5%
>=65 years	29 30.5%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61 (9.3)
Sex: Female, Male (Count of Participants)
Female	40 42.1%
Male	55 57.9%
Race/Ethnicity, Customized (participants) [Number]
White Non-Hispanic	87 91.6%
African American	4 4.2%
Asian	1 1.1%
Hispanic or Latino	1 1.1%
Patient Unwilling to Answer	2 2.1%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	30.8 (6.9)

Outcome Measures

1. Primary Outcome

Title	Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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
Measure Participants	86
ASES Functional Score	89.4 (13.3)
ASES Pain Score	0.7 (1.5)

2. Primary Outcome

Title	Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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
Measure Participants	85
Subjects with Evidence of Radiographic Failure	2 2.1%
Subjects with Radiographic Success	83 87.4%

3. Primary Outcome

Title	The Number of Device Related Serious Adverse Events.
Description	This outcome will measure the frequency of device related serious adverse events.
Time Frame	Two years

Outcome Measure Data

Analysis Population Description

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/Group Title	Investigational
Arm/Group Description	Frequency of device related serious adverse events
Measure Participants	86
Number [Device Related Serious Adverse Events]	0

4. Primary Outcome

Title	Survivorship
Description	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

Outcome Measure Data

Analysis Population Description

At the two year study endpoint there were 86 subjects that had data available at the two year time point.

Arm/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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
Measure Participants	86
Subject devices that survived	83 87.4%
Subject devices revised	3 3.2%

5. Secondary Outcome

Title	ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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 Summary scores
Measure Participants	95
ASES Functional Score 6 Weeks	59.8 (18.2)
ASES Functional Score 6 Months	80.3 (20.1)
ASES Functional Score 1 Year	88.1 (14.5)
ASES Pain Score 6 weeks	2 (2.4)
ASES Pain Score 6 months	1.3 (2.2)
ASES Pain Score 1 year	0.7 (1.5)

6. Secondary Outcome

Title	SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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 SF-12 Mental Health and Physical Composite Scores
Measure Participants	95
SF-12 Mental Health Scores Pre-Op	50 (13.5)
SF-12 Mental Health Scores 6 Weeks	55.1 (10.5)
SF-12 Mental Health Scores 6 Months	55.5 (8.4)
SF-12 Mental Health Scores 1 Year	54.3 (9.1)
SF-12 Mental Health Scores 2 Year	54.3 (8.3)
SF-12 Physical Composite Scores Pre-Op	32.7 (6.9)
SF-12 Physical Composite Scores 6 weeks	36.5 (8.3)
SF-12 Physical Composite Scores 6 months	44.2 (10.6)
SF-12 Physical Composite Scores 1 year	46.2 (10.3)
SF-12 Physical Composite Scores 2 year	47.6 (8.7)

Adverse Events

Time Frame	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).
Adverse Event Reporting Description	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.
Arm/Group Title	Sidus Stem-Free Shoulder System
Arm/Group Description	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
All Cause Mortality
	Sidus Stem-Free Shoulder System
	Affected / at Risk (%)	# Events
Total	1/95 (1.1%)
Serious Adverse Events
	Sidus Stem-Free Shoulder System
	Affected / at Risk (%)	# Events
Total	0/95 (0%)
Other (Not Including Serious) Adverse Events
	Sidus Stem-Free Shoulder System
	Affected / at Risk (%)	# Events
Total	28/95 (29.5%)
Musculoskeletal and connective tissue disorders
Other General Non-Shoulder Complication	5/95 (5.3%)	11
Fracture of Proximal Humerus	1/95 (1.1%)	1
Glenoid Implant Loosening	3/95 (3.2%)	3
Other Shoulder Related Complication	21/95 (22.1%)	29
Skin and subcutaneous tissue disorders
Dermatological	1/95 (1.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.