Clinical trial NCT04063943: Long Term Sidus PMCF
Official title: Long-Term Follow-up of the Sidus® Stem-Free Shoulder Arthroplasty System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Post-traumatic; Arthrosis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-08-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Safety: Monitoring frequency of AE, SAE and UADEs.
timeFrame: 10 Years
measure: Performance: ASES Scores
timeFrame: 10 Years
measure: Implant Survival
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Orthopaedic & Sports Medicine
state: Kentucky
city: Baltimore
country: United States
facility: MedStar Health
state: Maryland
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Calgary
country: Canada
facility: University of Calgary Sports Medicine Clinic
state: Alberta
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care London - Hand and Upper Limb Centre
state: Ontario
Study officials:
affiliation: Zimmer Biomet
name: Kacy Arnold, RN MBA
role: STUDY_DIRECTOR
References: