Long Term Sidus PMCF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis Post-traumatic; Arthrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sidus Stem-Free Total Shoulder

This arm will include all subjects who are implanted with the Sidus Stem-Free Total Shoulder Arthroplasty System

Group Type EXPERIMENTAL

Sidus Stem-Free Shoulder

Intervention Type DEVICE

Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Interventions

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Sidus Stem-Free Shoulder

Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No