NCT04063943

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

July 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

May 13, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

July 2, 2019

Last Update Submit

May 10, 2021

Conditions

OsteoarthritisPost-traumatic; Arthrosis

Outcome Measures

Primary Outcomes (3)

  • Safety: Monitoring frequency of AE, SAE and UADEs.

    Will be assessed by monitoring the frequency and incidence of adverse events (AE), serious adverse events (SAE), and unanticipated adverse device effects (UADE).

    10 Years

  • Performance: ASES Scores

    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.

    10 Years

  • Implant Survival

    Based on removal or intended removal of the device and determined using the OCY or Kaplan-Meier method.

    10 Years

Study Arms (1)

Sidus Stem-Free Total Shoulder

EXPERIMENTAL

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

Device: Sidus Stem-Free Shoulder

Interventions

Sidus Stem-Free ShoulderDEVICE

Device: Sidus Stem-Free Total Shoulder Arthroplasty System

Sidus Stem-Free Total Shoulder

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Norton Orthopaedic & Sports Medicine

Louisville, Kentucky, 40241, United States

Location

MedStar Health

Baltimore, Maryland, 21218, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

University of Calgary Sports Medicine Clinic

Calgary, Alberta, T2N 1N4, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St. Joseph's Health Care London - Hand and Upper Limb Centre

London, Ontario, N6A 4L6, Canada

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kacy Arnold, RN MBA

    Zimmer Biomet

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

August 21, 2019

Study Start

July 12, 2019

Primary Completion

January 31, 2020

Study Completion

March 31, 2020

Last Updated

May 13, 2021

Record last verified: 2021-05

Locations

US(4)CA(3)