Long Term Sidus PMCF

• ClinicalTrials.gov Identifier: NCT04063943
• Recruitment Status: Terminated
• First Posted: August 21, 2019
• Last Update Posted: December 17, 2020
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

Study Description

Brief Summary:

The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis; Post-traumatic; Arthrosis	Device: Sidus Stem-Free Shoulder	Not Applicable

Detailed Description:

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arms; This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System	Device: Sidus Stem-Free Shoulder; Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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.
3. Implant Survival [ Time Frame: 10 Years ]
   Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Zimmer Biomet

Investigators

• Study Director: Kacy Arnold, RN MBA; Zimmer Biomet

More Information

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT04063943
• Other Study ID Numbers: CSU2018-27E
• First Posted: August 21, 2019
• 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

Additional relevant MeSH terms:

Osteoarthritis; Joint Diseases; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases