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

Sponsor

Zimmer Biomet (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01700543

Collaborator

Zimmer, GmbH (Industry)

160

Enrollment

Locations

143

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Oct 1, 2012

Actual Primary Completion Date :

Jul 1, 2020

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

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

Outcome Measures

Primary Outcome Measures

Functional Performance (Constant & Murley Score) [5 Years]

Secondary Outcome Measures

Survival (Kaplan-Meier) [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	AKH Linz	Linz	Austria
2	Groupe Chirurgical Thiers	Grenoble	France
3	Centre Hospitalier Universitaire Toulouse	Toulouse	France
4	Charité	Berlin	Germany
5	Orthopaedische Chirurgie Muenchen	Munich	Germany
6	Gemeinschaftspraxis am Wall	Rinteln	Germany
7	Azienda Ospedaliera Universitaria Careggi	Florence	Italy
8	New Royal Infirmary of Edinburgh	Edinburgh	United Kingdom