Long Term Sidus PMCF
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04063943 |
Recruitment Status :
Terminated
(Sponsor has decided there is not a business need for this study and is not required to complete.)
First Posted : August 21, 2019
Last Update Posted : December 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis Post-traumatic; Arthrosis | Device: Sidus Stem-Free Shoulder | Not Applicable |
The data collected from this study will serve the purpose of assessing safety and performance of the Sidus Shoulder.
Safety: Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
Performance: Will be determined by analyzing the implant survival, overall pain and functional performances (based on the ASES Patient Questionnaire and range of motion) and radiographic parameters of subjects who received the Sidus Shoulder. Implant survival will be based on removal or intended removal and determined using the observed component years (OCY) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support Kaplan-Meier survivorship analysis. In the instance that there is sufficient data to perform Kaplan-Meier analysis, the analysis will be performed.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System |
Actual Study Start Date : | July 12, 2019 |
Actual Primary Completion Date : | January 31, 2020 |
Actual Study Completion Date : | March 31, 2020 |

Arm | Intervention/treatment |
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Experimental: Arms
This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System
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Device: Sidus Stem-Free Shoulder
Device: Sidus Stem-Free Total Shoulder Arthroplasty System |
- Safety: Monitoring frequency of AE, SAE and UADEs. [ Time Frame: 10 Years ]Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).
- Performance: ASES Scores [ Time Frame: 10 Years ]Will be determined by analyzing the ASES Questionnaire in subjects who received the Sidus Shoulder. 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.
- Implant Survival [ Time Frame: 10 Years ]Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient must have previously participated in the Sidus IDE clinical trial.
- Patient must not have undergone revision of the Sidus shoulder.
- Patient must be able and willing to complete the protocol required follow-up.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
Exclusion Criteria:
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Patient did not previously participate in the Sidus IDE clinical trial.
- Patient no longer has Sidus shoulder implanted.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063943
United States, Kentucky | |
Norton Orthopaedic & Sports Medicine | |
Louisville, Kentucky, United States, 40241 | |
United States, Maryland | |
MedStar Health | |
Baltimore, Maryland, United States, 21218 | |
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 | |
The Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19107 | |
Canada, Alberta | |
University of Calgary Sports Medicine Clinic | |
Calgary, Alberta, Canada, T2N 1N4 | |
Canada, Ontario | |
Kingston General Hospital | |
Kingston, Ontario, Canada, K7L 2V7 | |
St. Joseph's Health Care London - Hand and Upper Limb Centre | |
London, Ontario, Canada, N6A 4L6 |
Study Director: | Kacy Arnold, RN MBA | Zimmer Biomet |
Responsible Party: | Zimmer Biomet |
ClinicalTrials.gov Identifier: | NCT04063943 |
Other Study ID Numbers: |
CSU2018-27E |
First Posted: | August 21, 2019 Key Record Dates |
Last Update Posted: | December 17, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Osteoarthritis Joint Diseases Arthritis Musculoskeletal Diseases Rheumatic Diseases |