Long Term Sidus PMCF

Sponsor

Zimmer Biomet (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04063943

Collaborator

(none)

Enrollment

Locations

Arm

8.6

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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	N/A

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

Actual Enrollment :

0 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 :

Jul 12, 2019

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sidus Stem-Free Total Shoulder 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

Arm

Intervention/Treatment

Experimental: Sidus Stem-Free Total Shoulder

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

Safety: Monitoring frequency of AE, SAE and UADEs. [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 [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 [10 Years]
Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Norton Orthopaedic & Sports Medicine	Louisville	Kentucky	United States	40241
2	MedStar Health	Baltimore	Maryland	United States	21218
3	Rothman Institute	Philadelphia	Pennsylvania	United States	19107
4	The Rothman Institute	Philadelphia	Pennsylvania	United States	19107
5	University of Calgary Sports Medicine Clinic	Calgary	Alberta	Canada	T2N 1N4
6	Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
7	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zimmer Biomet

ClinicalTrials.gov Identifier:

NCT04063943

Other Study ID Numbers:

CSU2018-27E

First Posted:

Aug 21, 2019

Last Update Posted:

May 13, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Osteoarthritis

Study Results

No Results Posted as of May 13, 2021