Non-inflammatory Degenerative Joint Disease (NIDJD)NCT01700543
Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
An observational study of Non-inflammatory Degenerative Joint Disease (NIDJD) and Avascular Necrosis, run by Zimmer Biomet at 8 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Osteoarthritis
- What is being tested?
- Shoulder Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 152 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Oct 2012to 4 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.
Who may be able to join
- 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".
Who cannot join
- 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)
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Germany3 sites
Charité
Berlin
Orthopaedische Chirurgie Muenchen
Munich
Gemeinschaftspraxis am Wall
Rinteln
France2 sites
Groupe Chirurgical Thiers
Grenoble
Centre Hospitalier Universitaire Toulouse
Toulouse
About this study
Official title: Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.
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.
Read the 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.
- Conditions
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Osteoarthritis, Inflammatory Joint Disease (IJD), Rheumatoid Arthritis
- Being tested
- Shoulder Arthroplasty
- Keywords
- Stemless shoulder implant, Osteoarthritis, Rheumatoid Arthritis, Hemi Shoulder Arthroplasty, Total Shoulder Arthroplasty, Prospective, Multi-center, Europe, Non-Controlled, Good Bone Stock
- Medical subject headings
- Osteonecrosis, Osteoarthritis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder ArthroplastyProcedure or surgery
Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 Years
Secondary outcomes (1)
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
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2020
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-inflammatory Degenerative Joint Disease (NIDJD)Studies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zimmer, GmbH
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700543
- Sponsor's protocol ID
- CME2012-01E
- Other IDs
- 1201E
- Status last verified
- Jun 2026
- First submitted
- 2 Oct 2012
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sidus(TM) Stem-Free Shoulder - A Multi-center, Prospective, Non-controlled Post Market Clinical Follow-up Study.
- ClinicalTrials.gov ID
- NCT01700543
- Acronym / sponsor ID
- CME2012-01E
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Zimmer, GmbH
- Study start
- Oct 2012 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 4 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sidus Shoulder | – | Procedure: Shoulder ArthroplastyPatients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for hemi or total shoulder arthroplasty with good bone stock who fulfill all inclusion and none of the exclusion criteria.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shoulder ArthroplastyImplantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures. | Procedure or surgery | Experimental: Sidus Shoulder |
Primary outcome
Functional Performance (Constant & Murley Score)
Time frame: 5 Years
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.
1 secondary outcome
Survival (Kaplan-Meier)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Rohmer study director
Zimmer Biomet
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-inflammatory Degenerative Joint Disease (NIDJD) and Avascular Necrosis, run by Zimmer Biomet at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, France, Austria, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Performance (Constant & Murley Score) (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.