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

NCT01700543 | Active Not Recruiting

• 2 other identifiers: CME2012-01E1201E
• Study Type: observational
• Target: 152
• Locations: 5 countries
• Sites: 8

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.

Conditions

Non-inflammatory Degenerative Joint Disease (NIDJD); Avascular Necrosis; Osteoarthritis; Inflammatory Joint Disease (IJD); Rheumatoid Arthritis

Keywords

Stemless shoulder implant; Osteoarthritis; Rheumatoid Arthritis; Hemi Shoulder Arthroplasty; Total Shoulder Arthroplasty; Prospective; Multi-center; Europe; Non-Controlled; Good Bone Stock

Outcome Measures

Primary Outcomes (1)

• Functional Performance (Constant & Murley Score)

  The Constant \& Murley Score (CMS) is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.

  5 Years

Secondary Outcomes (1)

• Survival (Kaplan-Meier)

  10 years

Study Arms (1)

Experimental: Sidus Shoulder

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

Interventions

Shoulder Arthroplasty PROCEDURE

Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.

Experimental: Sidus Shoulder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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".

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zimmer Biomet: lead
• Zimmer, GmbH: collaborator

Study Sites (8)

AKH Linz

Linz, Austria

Location

Groupe Chirurgical Thiers

Grenoble, France

Location

Centre Hospitalier Universitaire Toulouse

Toulouse, France

Location

Charité

Berlin, Germany

Location

Orthopaedische Chirurgie Muenchen

Munich, Germany

Location

Gemeinschaftspraxis am Wall

Rinteln, Germany

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

New Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Osteonecrosis; Osteoarthritis; Arthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Shoulder

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: July 1, 2020
• Study Completion: March 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

FR (2); DE (3); AU (1); IT (1); GB (1)