COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Sidus(TM) Post Market Clinical Follow-up (PMCF) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01700543
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Last Update Posted : August 24, 2020
Zimmer, GmbH
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:

This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.

The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events.

The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant & Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder.

The Sidus Stem-Free Shoulder is not approved for use in the US.

Condition or disease Intervention/treatment
Non-inflammatory Degenerative Joint Disease (NIDJD) Avascular Necrosis Osteoarthritis Inflammatory Joint Disease (IJD) Rheumatoid Arthritis Procedure: Shoulder Arthroplasty

Detailed Description:

This study is a prospective, noncontrolled, multi-center post market clinical follow-up study involving orthopedic surgeons skilled in hemi and total shoulder arthroplasty procedures.

A total number of 160 subjects will be included in the study.

Ethics Committee (EC) approval for each site has to be obtained prior to conducting this study. Sequentially, all eligible patients will be offered study enrollment at each center to avoid potential selection bias. All potential subjects will be required to participate in an informed consent process and sign the EC approved written Informed Consent prior to study enrollment.

The study is designed to be prospective to ensure that the study population is representative of the type of population that the device is intended to treat. Patients will be selected according to the subject selection criteria described in section 8. All subjects will undergo preoperative, intraoperative and immediate postoperative assessments including physical examinations, radiographic evaluations and collection of quality of life metrics. Follow-up evaluations are to be conducted at 3 and 6 months, 1, 2, 5, 7 and 10 years postoperation.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.
Study Start Date : October 2012
Actual Primary Completion Date : July 2020
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.
Procedure: Shoulder Arthroplasty
Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.
Other Names:
  • HSA
  • TSA

Primary Outcome Measures :
  1. Functional Performance (Constant & Murley Score) [ Time Frame: 5 Years ]

Secondary Outcome Measures :
  1. Survival (Kaplan-Meier) [ Time Frame: 10 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.

Inclusion Criteria:

  • Patient is 18 to 80 years of age, inclusive.
  • The patient is skeletally mature.
  • Patient is suffering from severe shoulder pain and disability requiring unilateral or bilateral HSA or TSA based on physical exam and medical history.
  • Patient has failed conservative treatment.
  • Patient meets at least one of the following indications: Osteoarthritis, Posttraumatic arthrosis, Rheumatoid arthritis without humeral metaphyseal defects, Focal avascular necrosis of the humeral head, Previous surgeries of the shoulder that do no compromise the fixation.
  • Patient is willing and able to cooperate in the required post-operative therapy.
  • Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
  • Patient has participated in the Informed Consent process and has signed the Ethics Committee approved "Informed Consent".

Exclusion Criteria:

  • Patient is unwilling or unable to give consent or to comply with the follow-up program.
  • Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is an known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
  • Patient is known to be pregnant or breastfeeding.
  • Patient meets at least one of the contraindications: Soft or inadequate humeral bone (including osteoporosis and extensive avascular necrosis or rheumatoid arthritis) leading to poor implant fixation, Metaphyseal bony defect (including large cysts), Posttraumatic tuberosity non-union, Signs of infection, Irreparable cuff tear, Revision from a failed stemmed prosthesis, Charcot's shoulder (neuroarthropathy)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01700543

Layout table for location information
AKH Linz
Linz, Austria
Groupe Chirurgical Thiers
Grenoble, France
Centre Hospitalier Universitaire Toulouse
Toulouse, France
Berlin, Germany
Orthopaedische Chirurgie Muenchen
Munich, Germany
Gemeinschaftspraxis am Wall
Rinteln, Germany
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
United Kingdom
New Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Sponsors and Collaborators
Zimmer Biomet
Zimmer, GmbH
Layout table for additonal information
Responsible Party: Zimmer Biomet Identifier: NCT01700543    
Other Study ID Numbers: CME2012-01E
1201E ( Other Identifier: Zimmer, Inc (Sponsor) )
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Keywords provided by Zimmer Biomet:
Stemless shoulder implant
Rheumatoid Arthritis
Hemi Shoulder Arthroplasty
Total Shoulder Arthroplasty
Good Bone Stock
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes