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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Zimmer, Inc.
Sponsor:
Collaborator:
Zimmer, GmbH
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01700543
First received: October 2, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Functional Performance (Constant & Murley Score) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival (Kaplan-Meier) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2012
Estimated Study Completion Date: September 2024
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700543

Locations
Austria
AKH Linz Recruiting
Linz, Austria
Contact: Nikos Poulios, Dr       nikos.poulios@akh.linz.at   
Principal Investigator: Nikolaus Boehler, Prof         
France
Groupe Chirurgical Thiers Recruiting
Grenoble, France
Contact: Pierre Bellon-Champel, Dr       p.bellonchampel@ghm-grenoble.fr   
Principal Investigator: Pierre Bellon-Champel, Dr         
Centre Hospitalier Universitaire Toulouse Recruiting
Toulouse, France
Contact: Pierre Mansat, Prof       mansat.p@chu-toulouse.fr   
Principal Investigator: Pierre Mansat, Prof         
Germany
Charité Recruiting
Berlin, Germany
Contact: Markus Scheibel, Prof       markus.scheibel@charite.de   
Principal Investigator: Markus Scheibel, Prof         
Orthopaedische Chirurgie Muenchen Recruiting
Munich, Germany
Contact: Ernst Wiedemann, Prof       ocm@ocm-muenchen.de   
Principal Investigator: Ernst Wiedemann, Prof         
Gemeinschaftspraxis am Wall Recruiting
Rinteln, Germany
Contact: Stefan Bartsch, Dr       info@paw-rinteln.de   
Principal Investigator: Stefan Bartsch, Dr         
Italy
Azienda Ospedaliera Universitaria Careggi Recruiting
Florence, Italy
Contact: Renzo Angeloni, Dr    +390557947111      
Principal Investigator: Renzo Angeloni, Dr         
Switzerland
Kantonsspital St Gallen Recruiting
St Gallen, Switzerland
Contact: Bernhard Jost, Prof       bernhard.jost@kssg.ch   
Principal Investigator: Bernhard Jost, Prof         
United Kingdom
New Royal Infirmary of Edinburgh Recruiting
Edinburgh, United Kingdom
Contact: Julie McBirnie       julie.mcbirnie@nhs.net   
Principal Investigator: Julie McBirnie         
Sponsors and Collaborators
Zimmer, Inc.
Zimmer, GmbH
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01700543     History of Changes
Other Study ID Numbers: CME2012-01E, 1201E
Study First Received: October 2, 2012
Last Updated: February 5, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Zimmer, Inc.:
Stemless shoulder implant
Osteoarthritis
Rheumatoid Arthritis
Hemi Shoulder Arthroplasty
Total Shoulder Arthroplasty
Prospective
Multi-center
Europe
Non-Controlled
Good Bone Stock

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Necrosis
Osteonecrosis
Osteoarthritis
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on July 22, 2014