Clinical trial NCT01700543: Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
Official title: Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Zimmer, GmbH
First posted: 2012-10-04
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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)

Primary outcomes:
measure: Functional Performance (Constant & Murley Score)
timeFrame: 5 Years
Secondary outcomes:
measure: Survival (Kaplan-Meier)
timeFrame: 10 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: AKH Linz
city: Grenoble
country: France
facility: Groupe Chirurgical Thiers
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire Toulouse
city: Berlin
country: Germany
facility: Charité
city: Munich
country: Germany
facility: Orthopaedische Chirurgie Muenchen
city: Rinteln
country: Germany
facility: Gemeinschaftspraxis am Wall
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Edinburgh
country: United Kingdom
facility: New Royal Infirmary of Edinburgh
Study officials:
affiliation: Zimmer Biomet
name: Elliott Goff, PhD
role: STUDY_CHAIR
References: