OsteoarthritisNCT01878253

Sidus Stem-Free Shoulder IDE Study

A study testing Sidus Stem-Free Total Shoulder Arthroplasty System in people with Osteoarthritis and Posttraumatic Arthrosis, run by Zimmer Biomet at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis
What is being tested?: Sidus Stem-Free Total Shoulder Arthroplasty System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 11 sitesin 2 countries
Study dates: Jul 2013to Jan 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 10Show fewer

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.

Who cannot join

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.

Show all 28Show fewer

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.

Trial locations and contacts

11 sites in 2 countries.

Country

City, postcode or hospital

11 sites in 2 countries

United States8 sites

St. Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342
MedStar Health
Baltimore, Maryland, 21218
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, 40241
Rothman Institute
Philadelphia, Pennsylvania, 19107
Stanford University
Redwood City, California, 94063
University of California San Francisco - Orthopaedics Institute
San Francisco, California, 94158
Washington University
St Louis, Missouri, 63110

Other trials in United States

Canada3 sites

University of Calgary Sports Medicine Clinic
Calgary, Alberta, T2N 1N4
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St. Joseph's Health Care London - Hand and Upper Limb Centre
London, Ontario, N6A 4L6

Other trials in Canada

About this study

Official title: Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System

The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.

Read the 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.

Conditions: Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis
Being tested: Sidus Stem-Free Total Shoulder Arthroplasty System
Keywords: Total Shoulder Arthoplasty
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sidus Stem-Free Total Shoulder Arthroplasty SystemDevice

Study groups in NCT01878253
Study group	Role	What they receive
Investigational	Experimental	This arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System. Receives: Device: Sidus Stem-Free Total Shoulder Arthroplasty System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Two years
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
Measured: Two years
The Number of Device Related Serious Adverse Events.
This outcome will measure the frequency of device related serious adverse events.
Measured: Two years
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).
Measured: Up to Two years

Secondary outcomes (2)

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.
Measured: 6 weeks, 6 months, and 1 year
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.
Measured: Pre-Op, 6 weeks, 6 months, 1 year and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Jan 2019

First posted14 Jun 2013 (estimated)
Study startJul 2013
Primary completionMay 2018
Study completionJan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01878253
Sponsor's protocol ID: CIU2012-12E
Other IDs: G130026
Status last verified: Jul 2019
First submitted: 23 May 2013
Last updated: 15 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Trial of the Sidus Stem-Free Shoulder Arthroplasty System
ClinicalTrials.gov ID: NCT01878253
Acronym / sponsor ID: CIU2012-12E
Conditions: Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis
Keywords: Total Shoulder Arthoplasty
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: May 2018 (actual)
Study completion: Jan 2019 (actual)
First posted: 14 Jun 2013 (estimated)
Results: Posted 15 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Investigational	Experimental	Device: Sidus Stem-Free Total Shoulder Arthroplasty SystemThis arm will include all subjects who are implanted with the investigational Sidus Stem-Free Total Shoulder Arthroplasty System.

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (28 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sidus Stem-Free Total Shoulder Arthroplasty System	Device	Investigational

Primary outcome

Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Time frame: 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
Time frame: 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
The Number of Device Related Serious Adverse Events.
Time frame: Two years
This outcome will measure the frequency of device related serious adverse events.
Survivorship
Time frame: 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).

2 secondary outcomes

ASES Functional and Pain Scores at Intervals Other Than 2 Years as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire
Time frame: 6 weeks, 6 months, and 1 year
SF-12 Mental Health and Physical Composite Scores as Measured by the SF-12 Scoring Questionnaire.
Time frame: Pre-Op, 6 weeks, 6 months, 1 year and 2 years

Results and safety

Results posted to the registry on 15 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sidus Stem-Free Shoulder System	95	86

Primary outcome: Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire

Time frame: Two years. Mean (Standard Deviation). Unit: score on a scale

Measure	Sidus Stem-Free Shoulder System n = 86
ASES Functional Score	89.4 (13.3)
ASES Pain Score	0.7 (1.5)

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

Primary outcome: Absence of Radiographic Evidence of Failure or Pending Failure Based on Radiographic Assessment

Time frame: Two years. Count of participants. Unit: Participants

Measure	Sidus Stem-Free Shoulder System n = 85
Subjects with Evidence of Radiographic Failure	2
Subjects with Radiographic Success	83

Population analysed: 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.

Primary outcome: The Number of Device Related Serious Adverse Events.

Time frame: Two years. Number. Unit: Device Related Serious Adverse Events

Measure	Investigational n = 86
Value	0

Population analysed: 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.

Primary outcome: Survivorship

Time frame: Up to Two years. Count of participants. Unit: Participants

Measure	Sidus Stem-Free Shoulder System n = 86
Subject devices that survived	83
Subject devices revised	3

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

2 secondary outcomes are reported in the full results.

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sidus Stem-Free Shoulder System	0 of 95 (0%)	28 of 95 (29.5%)	1 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

11 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Sidus Stem-Free Total Shoulder Arthroplasty System in people with Osteoarthritis and Posttraumatic Arthrosis, run by Zimmer Biomet at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain and Function as Measured by the American Society of Shoulder and Elbow Surgeons Questionnaire (time frame: Two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01878253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.