Status:
WITHDRAWN
Long Term Sidus PMCF
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteoarthritis
Post-traumatic; Arthrosis
Eligibility:
All Genders
Phase:
NA
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 even...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04063943
Start Date
July 12 2019
End Date
March 31 2020
Last Update
May 13 2021
Active Locations (7)
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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