Revision of a Shoulder ProsthesisNCT05358574
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
An observational study of Revision of a Shoulder Prosthesis, run by Zimmer Biomet at 1 site in Germany.
Trial summary
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Revision of a Shoulder Prosthesis
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 22 Apr 2022to 16 Jul 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be comprised of a consecutive series of cases implanted with the Anatomical Shoulder Bipolar System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible
- Patient should have received the Anatomical Shoulder Bipolar System
- Patient should have signed the Informed Consent Form
- Patient is 18-100 years of age, inclusive
- Patient is skeletally mature
Who cannot join
- Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule
- 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 a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them
- Patient is known to be pregnant or breastfeeding
- Musculoskeletal situation that enables the application of a regular hemi or total shoulder system
- Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is possible
- Patient's physical conditions that would impair achieving adequate implant support, and/or prevent the use of an appropriately sized implant (e.g. due to insufficient quality or quantity of bone).
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- Signs of infection
- Non-functional deltoid muscle
- Charcot's shoulder (neuroarthropathy)
- Presence of significant injury to the upper brachial plexus
- Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Helios ENDO-Klinik
Hamburg, 22767
Jörg Neumann, Dr.med
Jörg Neumann, Dr.med
About this study
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ Bipolar System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement.
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Read the detailed description
The Anatomical Shoulder Bipolar System is intended for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible. The system is intended for long-term implantation into the human shoulder joint.
One site will be involved in this study. The aim is to include a maximum of 40 consecutive series cases who received the Anatomical Shoulder Bipolar starting from 2009 until 2020. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervalls will be available in medical notes and collected retrospectively. During follow-up visits at 1, 2, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
- Conditions
- Revision of a Shoulder Prosthesis
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received the Anatomical Shoulder Bipolar | Patients who received the Anatomical Shoulder Bipolar and were operated according to the product's IFU and surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and frequency of revisions [Product safety based on implant survivorship]
Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. A Kaplan Meier survival curve will be calculated.
Measured: From operation to study completion, 1-10 years
Secondary outcomes (4)
Constant and Murley Score
The patient will be evaluated at each interval (1, 2, 5, 7, 10 years) The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points.
Measured: From post-operative to final follow-up visit, 1-10 years
Oxford Shoulder Score
The patient will be evaluated at each interval (1, 2, 5, 7, 10 years) The OSS is a self-assessment of shoulder pain and function with 12 items; pain (2), interference with pain (2), and daily functions (8). Each response is answered with a five point Likert scale. The total score is the sum of the 12 items, with lower scores indicating a more favorable outcome.
Measured: From post-operative to final follow-up visit, 1-10 years
EuroQol Five Dimensions Questionnaire
The patient will be evaluated at each interval (1, 2, 5, 7, 10 years)
The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. It is accompanied by the patient's self-assessment with the VAS.
Each dimension is assigned one of three discrete levels for evaluation on the day of administration:
Level 1 - No problems, no disability Level 2 - Some problems, moderate disability Level 3 - A lot of problems, severe disability
The final score is a five digit composite of the responses ranging between 33333 - 11111 with 243 possible combinations in between.
Measured: From post-operative to final follow-up visit, 1-10 years
X-rays
Performance and clinical benefits will be assessed by radiographic evaluation. Radiographs (A/P and axillary view) of the operated shoulder will be taken at each interval.
Measured: From post-operative to final follow-up visit, 1-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start22 Apr 2022
- Primary completion16 Jul 2033 (estimated)
- Study completion16 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Revision of a Shoulder ProsthesisStudies 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
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358574
- Sponsor's protocol ID
- MDRG2017-89MS-130E
- Status last verified
- Oct 2025
- First submitted
- 22 Apr 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Anatomical Shoulderᵀᴹ Bipolar System (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
- ClinicalTrials.gov ID
- NCT05358574
- Acronym / sponsor ID
- MDRG2017-89MS-130E
- Conditions
- Revision of a Shoulder Prosthesis
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 16 Jul 2033 (estimated)
- Study completion
- 16 Jul 2033 (estimated)
- First posted
- 3 May 2022 (actual)
- 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.
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to collect long-term data confirming safety, performance and clinical benefits of the Anatomical Shoulder Bipolar System (Implants and Instrumentation) when used as a salvage solution in shoulder replacement.
The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Detailed description
The Anatomical Shoulder Bipolar System is intended for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible. The system is intended for long-term implantation into the human shoulder joint.
One site will be involved in this study. The aim is to include a maximum of 40 consecutive series cases who received the Anatomical Shoulder Bipolar starting from 2009 until 2020. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervalls will be available in medical notes and collected retrospectively. During follow-up visits at 1, 2, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received the Anatomical Shoulder Bipolar | – | –Patients who received the Anatomical Shoulder Bipolar and were operated according to the product's IFU and surgical technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of a consecutive series of cases implanted with the Anatomical Shoulder Bipolar System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (5 listed)
- The Anatomical Should Bipolar Adaptor is indicated for hemi shoulder replacement as a salvage solution in situations, where a Zimmer Anatomical Shoulder Inverse/Reverse prosthesis was originally planned, but it is intra-operatively found that the attachment of the Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is not possible
- Patient should have received the Anatomical Shoulder Bipolar System
- Patient should have signed the Informed Consent Form
- Patient is 18-100 years of age, inclusive
- Patient is skeletally mature
Key exclusion criteria (11 listed)
- Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule
- 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 a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them
- Patient is known to be pregnant or breastfeeding
- Musculoskeletal situation that enables the application of a regular hemi or total shoulder system
- Good quantity or quality of the glenoid bone, where the fixation of a Zimmer Anatomical Shoulder Inverse/Reverse glenoid fixation is possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and frequency of revisions [Product safety based on implant survivorship]
Time frame: From operation to study completion, 1-10 years
Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events. A Kaplan Meier survival curve will be calculated.
4 secondary outcomes
Constant and Murley Score
Time frame: From post-operative to final follow-up visit, 1-10 years
Oxford Shoulder Score
Time frame: From post-operative to final follow-up visit, 1-10 years
EuroQol Five Dimensions Questionnaire
Time frame: From post-operative to final follow-up visit, 1-10 years
X-rays
Time frame: From post-operative to final follow-up visit, 1-10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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.
Hassan Achakri study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Revision of a Shoulder Prosthesis, run by Zimmer Biomet at 1 site in Germany.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Nicoux (+330672613502, julie.nicoux@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and frequency of revisions [Product safety based on implant survivorship] (time frame: From operation to study completion, 1-10 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 25 Nov 2025.