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

Rheumatoid Arthritis Clinical Trial

Official title:

Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01700543
• Other study ID #: CME2012-01E
• Secondary ID: 1201E
• Status: Active, not recruiting
• Start date: October 2012
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: April 2025
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Shoulder Arthroplasty
Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.

Locations

Country	Name	City	State
Austria	AKH Linz	Linz
France	Groupe Chirurgical Thiers	Grenoble
France	Centre Hospitalier Universitaire Toulouse	Toulouse
Germany	Charité	Berlin
Germany	Orthopaedische Chirurgie Muenchen	Munich
Germany	Gemeinschaftspraxis am Wall	Rinteln
Italy	Azienda Ospedaliera Universitaria Careggi	Florence
United Kingdom	New Royal Infirmary of Edinburgh	Edinburgh

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Zimmer, GmbH

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Survival (Kaplan-Meier)	The Kaplan-Meier (KM) method is a non-parametric method used to estimate the survival probability from observed survival times (Kaplan and Meier, 1958).; The survival probability at time ti, S(ti), is calculated as follow: S(ti)=S(ti-1)(1-dini); Where,; S(ti-1) = the probability of being alive at ti-1 ni = the number of patients alive just before ti di = the number of events at ti t0 = 0, S(0) = 1	10 years